Current Good Manufacturing Practices D.

SANITARY OPERATION
1. General maintenance. Buildings, fixtures, and other
CGMP refers to the Current Good Manufacturing physical facilities of the plant shall be maintained in a
Practice regulations enforced by the FDA. CGMPs provide sanitary condition and shall be kept in repair sufficient to
for systems that assure proper design, monitoring, and prevent food from becoming adulterated within the meaning
control of manufacturing processes and facilities. of the act. Cleaning and sanitizing of utensils and
Adherence to the CGMP regulations assures the identity, equipment shall be conducted in a manner that protects
strength, quality, and purity of drug products by requiring against contamination of food, food contact surfaces, or
that manufacturers of medications adequately control food-packaging materials.
manufacturing operations. This includes establishing strong 2. Substances used in cleaning and sanitizing; storage
quality management systems, obtaining appropriate quality of toxic materials. Cleaning compounds and sanitizing
raw materials, establishing robust operating procedures, agents used in cleaning and sanitizing procedures shall be
detecting and investigating product quality deviations, and free from undesirable microorganisms and shall be safe
maintaining reliable testing laboratories. and adequate under the conditions of use.
3. Education and Training.
DEFINITION OF TERMS  A training program shall be established and
1. Critical control point means a point in a food process maintained to define appropriate training
where there is a high probability that improper control may necessary for food handlers and supervisors on
cause, allow, or contribute to a hazard or to filth in the final proper food handling techniques and food-
food or decomposition of the final food. protection principles.
2. Quality control operation means a planned and  Training shall be regularly instituted and validated
systematic procedure for taking all actions necessary to to ensure compliance of personnel to established
prevent food from being adulterated within the meaning of procedures and work instructions
the act 4. Supervision
3. Adulteration means to make impure by mixing in a  Authority and responsibility for assuring compliance
foreign or inferior substance. to established procedures and work instructions
4. Contaminants is any biological or chemical agent, and identifying sanitation failures or food
foreign matter or other substances that are not intentionally contamination by all personnel shall be clearly
added to food. assigned to competent supervisory personnel (Shift
5. Disinfection is the reduction by means of chemical Hygiene and Sanitation Officer or any other title).
agents or physical methods. Overall sanitation of the plant shall be under the
6. Quality Assurance is the activity of providing the supervision of one or more competent individuals
evidence needed to establish confidence that the quality given the responsibility for this function.
function is being performed adequately.  Personnel responsible for identifying sanitation
failures or food contamination problems should
A. PERSONNEL have an educational background or experience, or
The plant management shall take all reasonable measures a combination thereof, with a level of competency
and precautions to ensure the following: necessary for production of clean and safe food.
1. Disease control. Any person who, by medical 5. Sanitary Facilities
examination or supervisory observation, is shown to have  Water Supply - Water shall be of the quality
abnormal source of microbial contamination, shall be necessary for the product, process or use.
excluded from any operations which may be expected to -potable water
result in such contamination until the condition is corrected. -non-potable water
2. Cleanliness. All persons working in direct contact with  Effluent and Waste Disposal – The facility shall
food, food-contact surfaces, and food-packaging materials have an efficient effluent and waste disposal
shall conform to hygienic practices while on duty to the system and facilities for storage of waste and
extent necessary to protect against contamination of food. inedible material, should at all times be maintained
3. Education and training. Personnel responsible for in good order and repair and in conformance with
identifying sanitation failures or food contamination should DENR regulations. All effluent lines (including
have a background of education or experience, or a sewer systems) should be large enough to carry
combination thereof, to provide a level of competency peak loads and shall be so constructed as to avoid
necessary for production of clean and safe food. contamination of potable water supplies.
 Changing Facilities Adequate, suitable and
B. BUILDING AND FACILITIES conveniently located changing facilities shall be
1. Grounds. The grounds about a food plant under the provided.
control of the operator shall be kept in a condition that will  Toilets – Adequate number of toilets shall be
protect against the contamination of food. provided in all establishments. Toilets shall be
2. Plant construction and design. Plant buildings and designed and constructed to ensure hygienic
structures shall be suitable in size, construction, and design removal of waste matter.
to facilitate maintenance and sanitary operations for food-  Hand Washing Facilities in Processing Areas –
manufacturing purposes. Adequate and conveniently located facilities for
hand washing and drying shall be provided where
C. EQUIPMENT appropriate. Where appropriate, facilities for hand
 All plant equipment and utensils shall be so designed disinfection should also be provided.
and of such material and workmanship as to be  Disinfection Facilities - Where appropriate,
adequately cleanable and shall be properly adequate facilities for cleaning and disinfection of
maintained. working implements and equipment should be
 The design, construction, and use of equipment and provided.
utensils shall preclude the adulteration of food with  Facilities for Storage of Waste and Inedible Material
lubricants, fuel, metal fragments, contaminated water, - Facilities shall be provided for the storage of
or any other contaminants. waste and inedible material prior to removal from
 All equipment should be so installed and maintained as the processing plant.
to facilitate the cleaning of the equipment and of all  Eating Facilities – Consumption of food in
adjacent spaces. processing areas, warehouses and offices inside
the production areas and in laboratories shall be
 strictly forbidden, as such a eating facilities shall be 4. Laboratory Facilities and Controls
provided. 4.1 The laboratory shall be well designed to suit the
6. Maintenance and Sanitation relevant operations.
 General Maintenance. There shall be procedures 4.2 It shall be separated physically from the production
for general maintenance of the plant and its areas.
premises. 4.3 Its concomitant facilities – laboratory equipment and
 Cleaning Procedures and Methods. Cleaning can instruments shall be suitable to the testing procedures
be carried out by the separate or the combined use undertaken.
of physical methods, such as heat, scrubbing,
turbulent flow, vacuum cleaning or other methods G. DOCUMENTATION
that avoid the use of water, and chemical methods 1. All documents related to the manufacture and operations
using detergents, alkalis or acids. from raw, packaging materials, master production and
 Cleaning Programs. Cleaning and disinfections control, batch production, laboratory control and batch
programs should ensure that all parts of the production record review should be prepared reviewed,
establishment are appropriately clean and should approved and distributed according to written procedures.
include the cleaning of cleaning equipment. 2. The issuance, revision, superseding and withdrawal of all
 Animal and Vermin Control. There shall be documents, should be controlled by maintaining revision
procedures for animal and vermin control histories.
 Pest Control. Pests pose a major threat to the 3. A procedure should be established for retaining all
safety and suitability of food. Pest infestations can appropriate documents (e.g. development history reports,
occur where there are breeding sites and a supply scale-up reports, technical transfer reports, process
of food. Good hygiene practices should be validation reports, training records, production records,
employed to avoid creating an environment control records, and distribution records). The retention
conducive to pests. period for these documents should be specified.
4. Records of major equipment use, cleaning, sanitation,
E. PRODUCTION AND PROCESS CONTROLS and/or sterilization and maintenance shall show the date,
All operations in the receiving, inspecting, transporting, time (if appropriate), product, and batch number of each
segregating, preparing, manufacturing, packaging, and batch processed in the equipment and the person who
storing of food should be conducted in accordance with performed the cleaning and maintenance.
adequate principles. There shall be appropriate quality 5. Specifications shall be established and documented for
control operations procedures to ensure that food is raw materials, labeling and packaging materials.
suitable for human consumption and that food-packaging Acceptance criteria should be established and documented
materials are safe and suitable. for in-process controls.
1.1 Raw Materials and Other Ingredients
There shall be procedures and work instructions for the H. QUALITY AUDIT
sanitary handling of raw materials and other A quality audit consists of an examination and assessment
ingredients. of all or part of a quality system with the specific purpose of
1.2 Manufacturing Operations improving it. A quality audit may be conducted by outside or
Procedures and work instructions shall be established independent specialists or an internal audit team
for the sanitary handling and maintenance of equipment designated by the management for this purpose. Such
and utensils for manufacturing operations audits may also be extended to suppliers and contractors, if
necessary. A report should be made at the completion of
F. QUALITY CONTROL each quality audit.
1. Quality Management
1.1 A quality control system should be established to I. WAREHOUSE AND DISTRIBUTION
ensure that products contain the correct materials of There shall be appropriate procedures for sanitary handling
specified quality and quantity and are manufactured under of food on storage and distribution. Storage and
proper conditions following standard procedures to ensure transportation of finished food shall be under conditions that
the quality and safely of the product will protect food against physical, chemical, and microbial
1.2 The quality control involves sampling, inspecting and contamination as well as against deterioration of the food
testing of starting materials, in process, intermediate, bulk and the container.
and finished products. It also includes where applicable, Warehouses should be kept free from rodents, insects,
review of batch documentation, sample retention program, birds and other pests. All product spills should be cleaned
stability studies, product complaints, product recalls, and up immediately, as this is an important preventive measure
maintaining correct specifications of materials and products. against pests

2. Testing of Reprocessed Products J. PRODUCT RECALL

2.1 The methods of reprocessing should be evaluated to 1. All quality-related complaints, whether received orally or
ensure that they do not affect the quality of the product. in writing, shall be recorded and investigated according to a
2.2 Additional testing of any finished product, which has written procedure. Documented records of complaint should
been reprocessed, should be performed. be retained to evaluate trends, product-related frequencies
and severity with a view to taking additional and if
[Link] of Returned Goods appropriate, immediate corrective action.
3.1 Returned products should be identified and stored 2. There shall be a written procedure that defines the
separately either in allocated area or by moveable barrier circumstances under which a recall should be considered.
such as rope or tape. The recall procedure should designate who should be
3.2 All returned products should be tested if necessary, in involved in evaluating the information, how a recall should
addition to physical evaluation before being released for be initiated, who should be informed about the recall, and
distribution. how the recalled material should be treated
3.3 Any returned products that do not comply with the 3. In the event of a serious or potentially life-threatening
original specification should be rejected. situation, all concerned local and national authorities shall
3.4 Rejected products should be disposed according to be informed and their advice sought. If it is necessary to get
appropriate procedures. in touch with concerned international authorities,
3.5 Records of returned products must be maintained. communication should come from the national authority and
not from the local companies.
4. It is important to have a record of the traceability of raw
materials, packaging materials, processing data and from other equipment to avoid congestion and to ensure
laboratory results which could be relevant to analyze the that products do not become admixed or confused with one
effectiveness of the implementation of procedure for another.
product recall. 3.3 Maintenance
3.3.1 Equipment shall be subjected to regular maintenance
checks at appropriate intervals to prevent malfunctions or
K. RETENTION OF SAMPLES contamination that can alter the strength, safety, identity,
1. An appropriate and adequate number of samples of the quality, or purity of the product beyond established limits.
finished batch product shall be withdrawn from the
production/packaging line to serve as reserve or retention SECTION 4. SANITATION AND HYGIENE
samples. The number shall be such that it will be adequate High level of sanitation shall be practiced in every aspect of
for a complete testing, if and when necessary to do so. manufacturing drug product. Scope of the sanitation and
2. Retention samples shall be stored in an area compatible hygiene program covers personnel, premises, equipment
with storage condition prevailing in the market. and apparatus, production materials and containers and
anything that could become a source of contamination to
L. SUB-CONTRACTING OF MANUFACTURE the product. Potential sources of contamination shall be
The conditions of contract manufacturing should be defined, eliminated through an integrated comprehensive program of
agreed, and controlled to avoid misunderstandings, which sanitation and hygiene. In all instances, the sanitation and
could result in a product or work of unacceptable quality. All the hygiene procedures should be validated and
aspects of contracted work should be specified to obtain a periodically assessed to ensure that the effectiveness of the
quality product conforming to the agreed standards. There operation meets the requirements.
should be a written contract between the principal and the 4.1 Personnel
contract manufacturer to clearly establish the duties and 4.1.1 All personnel, prior to and during employment, shall
responsibilities. undergo health examinations. Operators required to
undertake visual inspections shall also undergo periodic
BASIC GMP GUIDELINES eye examination.
SECTION 1. PERSONNEL 4.1.5 Direct contact shall be avoided between the operator
1.1 There shall be an adequate number of personnel at all and raw materials, intermediate or bulk products.
levels having knowledge, skills and capabilities relevant to 4.2 Premises
their assigned functions, in good mental and physical health 4.2.4 Waste materials shall not be allowed to accumulate. It
to be able to execute their duties. shall be collected in suitable receptacles for removal to
1.2 The premises for manufacturing shall be of suitable collection points outside the buildings and should be
size, design, construction and location to facilitate proper disposed off properly in a safe sanitary manner at regular
operation, cleaning and maintenance. The individual and adequate intervals.
working areas shall be adequate so that any risk of 4.3 Equipment
confusion, cross-contamination and other mistakes that will 4.3.3 Cleaning and storing of mobile equipment and storing
adversely affect the quality of drugs and devices will be of cleaning materials shall be done in rooms separated from
avoided. processing areas.

SECTION 2. PREMISES SECTION 5. STORAGE OF STARTING AND PACKAGING

2.1 Location, Construction, Design & Lay-out MATERIALS, INTERMEDIATES, BULK PRODUCTS AND
2.1.1 Premises shall be so located and protected against FINISHED PRODUCTS
contamination from the environment. 5.1 The materials shall be stored under suitable
2.1.2 Premises shall be constructed and maintained to environmental condition. Any special storage condition shall
protect against weather, flood, ground seepage and the be provided, and conditions monitored.
access and harboring of vermin, rodents, birds, insects or 5.1.1 Intermediate, Bulk and Finished Products
other animals. 5.1.2 Intermediates, bulk products and finished products
2.1.3 The layout of rooms, corridors, and spaces shall shall be held pending quality control testing and disposition.
provide for logical movements of materials and personnel 5.1.3 Each container of intermediates, bulk products and
with minimal traffic for operations to be carried out in finished products delivered to the storage area shall be
defined areas and to avoid cross contamination. checked for proper identification and condition.
2.1.4 In all manufacturing rooms (processing and
packaging), air supply and air exhaust points shall not be so SECTION 6. PRODUCTION
close or so disposed as to restrict or negate the supply of Production shall follow defined procedures capable to
clean air to worksites and or movement of product dust or provide assurance of consistently yielding drug products
other contaminants away from worksites. The airflow that conform to their specifications
pattern within the facility and each manufacturing area and Section 6.1. Basic Manufacturing Requirements
the throughput rate of air shall be selected to afford Equipment shall be technically suitable, well sited (so as not
adequate protection to the products and personnel. to interfere with other operations), easy to clean and
maintain. The design, siting and operation of equipment
SECTION 3. EQUIPMENT shall ensure that no contamination from foreign materials
Equipment used in the manufacturing of drug products shall such as rust, lubricants, abraded particles or foreign
be of appropriate design and construction, adequate size ingredients should occur.
and suitably located in order to assure product quality and Section 6.2. Product Validation
process reproducibility and to facilitate its cleaning and A company should only use validated manufacturing
maintenance. processes. All established processes, materials or
3.1 Design and Construction products, procedures, activities, systems, equipment or
3.1.1 The equipment surfaces coming in contact with any mechanism used in manufacture or control procedures may
raw material, intermediate, bulk or finished product shall not be validated utilizing a retrospective approach.
be reactive, additive or absorptive so as to alter safety, Section 6.3. Contamination
strength, identity, quality or purity of the drug beyond the The presence in a drug product of any contaminant is
established limits. unacceptable.
3.2 Installation and Location
3.2.1 Equipment shall be suitably installed and located to SECTION 7. PACKAGING
eliminate cross contamination. The function of the packaging operation is to subdivide and
3.2.2 Equipment shall be located at a sufficient distance control bulk product. These operations shall be performed
under strict control designed to protect the identity, integrity There shall be written procedures for environmental
and quality of the final package. monitoring, for gowning, cleaning and disinfection within
Section 7.4. Coding of Components manufacturing areas. These procedures shall contain
Labels, cartons and other components that require pre- “target”, “alert” and “action” limits for environmental
coding with a batch number or lot number, expiration date, contaminants. The procedure shall include the action/s to
or other information specific to a given packaging order be taken if the limit is exceeded, or particular indicator
shall be strictly controlled at all stages of the process, from organisms are isolated
the time of delivery from the warehouse until they become Section 9.10. Stability Study
parts of finished packages. A stability-testing program shall be designed to assess the
Section 7.5. Line Clearance stability characteristics of drug products and to determine
Immediately prior to the placement of materials on the storage conditions and expiration date.
packaging line, a line clearance check shall be made by a
designated responsible packaging person in accordance Section 10. DOCUMENTATION
with a written line clearance procedure. It refers to the part of management information system,
Section 7.7. Operating Practices which includes specifications, procedures, methods and
Products of similar appearance shall not be packaged in instructions, reports and records and other documents that
close proximity unless there is physical segregation. are required for planning, organizing, controlling and
Section 7.8. Completion of the Packaging Operations evaluating the whole activities of drug manufacturing.
10.1 General Provisions
Section 8. FINISHED PRODUCT QUARANTINE AND 10.1.1 Documents shall be prepared and designed carefully
DELIVERY TO WAREHOUSE for easy, correct and effective use.
Finished product quarantine is the last point of control 10.1.2 Documents shall contain records of activities within
before the product enters the warehouse and becomes production, quality control, equipment maintenance,
available for distribution to the market. Strict controls shall warehouse, distribution and other specific activities related
be exercised to ensure that the product and its packaging to Good Manufacturing Practice.
records meet all specified requirements before release to 10.1.5 Documents shall contain all-important data, which
the warehouse. shall be reviewed, updated or amended as necessary and
Section 8.9. Control record for shipment of finished formally authorized. It shall include provision for periodic
products review and revision.
A system designed to control the shipment of finished 10.1.8 Any error made or detected on a document shall be
products shall assure that the first expiry material is corrected in such a manner that the original entry is not lost.
distributed first. The correction is made close to the original entry, initialed
The system shall generate records from which the and dated.
distribution of each batch or lot of drug product can be 10.1.10 Each manufacturing document shall be dated,
readily determined to facilitate investigation or recall if signed and authorized by the production manager and
necessary. quality control manager. Departments or other persons
Written procedures describing the distribution of products receiving copies of the document should be listed at least
(drug, devices and other products) shall be established and on the original copy.
followed
Document of specifications shall include specifications for
Section 9. QUALITY CONTROL raw materials, packaging materials, intermediate products,
Quality Control is an essential part of Good Manufacturing bulk products and finished products.
Practices to provide assurance that the products will be
consistently of a quality appropriate to their intended use. 10.2 Specifications
The involvement and commitment of all concerned at all 10.2.1 Raw Material Specifications
stages are mandatory towards the achievement of this 10.2.2 Packaging Material Specifications
quality objective from the start of manufacturing to the 10.2.3 Specifications for Intermediate Products, Bulk
distribution of the finished product. An independent quality Products and Finished Products
control unit shall be established.
Section 9.2. Control Laboratory 10.3 Production Documents
9.2.1. Premises 10.3.2 Master Processing Procedure
Control laboratories shall be designed, equipped 10.3.3 Master Packaging Procedure
and of enough space to suit relevant operations. 10.3.4 Batch Processing Record
Provisions shall be made for the proper and safe 10.3.5 Batch Packaging Record
storage of waste materials awaiting disposal. Toxic
substance and inflammable materials shall be stored in The storage and distribution of drug products shall be
suitably designed and storage. documented. The most important documents in this area
9.2.3. Equipment are inventory card and distribution record.
Equipment and instrument shall be serviced and
calibrated at pre-specified intervals and their records shall 10.5 Warehouse and Distribution Documents
be maintained. Pre-check of the instrument to ensure its 10.5.1 Inventory Card
satisfactory functioning shall be conducted daily or prior to The card contains record of the quantity received, issued
using the instrument for performing an analytical test. and balance stock of the starting material, intermediate
Section 9.4. Control of Starting Materials, Intermediate, product, bulk product or finished product at any time.
Bulk and Finished Products 10.5.2 Record of Distribution of Finished Product
Section 9.4.2. Sampling is an important operation in which [Link] The record shall be complete, up to date and the
only a small fraction of a batch is taken. Valid conclusions progressive data of distribution can be easily followed and
on the whole cannot be based on tests which have been retrievable to enable the manufacturer to impose a drug
carried out on non-representative samples. Correct recall quickly and effectively whenever it becomes
sampling is thus an essential part of a system of quality necessary.
assurance. 10.7 Documents for Specific Equipment
Section 9.4.3. Test Requirement 10.7.1 Procedure for Operating a Specific Equipment
Each raw material shall be tested for conformity with A procedure for operating specific equipment is required to
specification for identity, strength, purity and other quality prevent mishandling of the equipment that may influence
parameters. the quality of product utilizing the equipment or cause
Section 9.5. Environmental Control damage to the equipment. The procedure is normally
adapted from the equipment manual. Section 12. GUIDELINES FOR HANDLING OF PRODUCT
10.7.2 Procedure and Record of Calibration of a COMPLAINT, PRODUCT RECALL AND OR RETURNED
Specific Equipment PRODUCT
A procedure for calibrating specific equipment is required to 12.1 Product Complaint and Report
ensure that the equipment always weighs or measures A product complaint and report may relate to the quality,
accurately. The procedure shall include the calibration adverse reaction or other therapeutic effect of the product.
schedule, reference standards, reagents and tools to be All complaints and reports shall be thoroughly investigated
used and the method of calibrating or the reference manual and evaluated.
used for calibrating the equipment. The calibration 12.1.1 A product complaint and report may be due to:
performed and its result shall be documented. [Link] a complaint about quality whether
10.8 Procedure and Record of Self Inspection physical, chemical or biological defect of the product or its
10.8.1 The procedure shall include the forms to be packaging
used and check list for self-inspection, team composition [Link] a complaint or report of adverse reaction
and the schedule of inspection. like allergy, toxicity, fatal or near fatal reaction and other
10.8.2 The record shall contain the team’s medical reaction and
evaluation and conclusion of the inspection and corrective [Link] a complaint or report of the product
actions to be taken as necessary. therapeutic activity such as the product lack of efficacy or
10.10 Documents for Handling of Product Complaints, poor clinical response
Product Recall, 12.1.2 A system for handling product complaint shall be
Returned Products and Destruction of Products designed and include written procedures and indicate the
10.10.1 Procedure and Record for Product Complaints responsibility of persons through whom the complaints are
[Link] This procedure shall include the definition of to be channeled. A record shall be made for all product
product complaint and adverse reaction, the type of complaints and reports received.
complaint and report, method of handling and evaluation of 12.1.5 Follow-up Action
the complaint and report. A follow-up action shall be taken after investigation
10.10.2 Procedure and Record for Returned Products and evaluation of the product complaint and report. The
[Link] The procedure shall specify the guidelines for action may include:
making decision either to salvage, reprocess or destroy the [Link] corrective action where applicable
returned product. Returned products, which cannot be [Link] recall of the batch or all the finished
reprocessed, shall be destroyed. The handling, disposition products
and follow-up actions of returned products should be [Link] other appropriate action
documented and reported. 12.2 Product Recall
A product recall is a process of withdrawing one or more
Section 11. SELF INSPECTION batches or all of a certain product from market distribution.
Self-inspection shall be performed routinely. All A product recall is instituted following discovery of a quality
recommendations for corrective actions shall be defect or if there is a report of serious adverse reaction of a
implemented. A team consisting of personnel who can product which may cause health risk. Total withdrawal of a
evaluate the implementation of Good Manufacturing product from market distribution may result in a suspension
Practices objectively shall be appointed. The procedure and or discontinuation of manufacturing of the product.
record for self-inspection shall be documented. 12.3 Returned Product
11.1 Items for Self-Inspection A returned product is a finished product which is already in
A checklist for self-inspection shall be established to distribution and returned to the manufacturer due to
provide a minimum and uniform standard of requirements. complaint, damage, expiration, validity or other reasons
The list shall include questionnaires on Good Manufacturing such as the condition of the container or package which
Practices requirements covering the following items: may cast doubt on the product identity, quality, quantity and
11.1.1 personnel; premises including personnel safety.
facility Based on the evaluation, the returned products are
11.1.2 storage of starting materials and finished categorized as follows:
products 12.3.1 returned products which still meet their
11.1.3 equipment specifications and therefore may be returned to inventory
11.1.4 production 12.3.2 returned products which may be
11.1.5 quality control reprocessed and
11.1.6 documentation and 12.3.3 returned products which do not meet their
11.1.7 maintenance of building and equipment specifications and cannot be reprocessed
11.2 Team of Self Inspection
Management shall appoint a team of self-inspection Emergency Preparedness
consisting of at least three members who are experts in
their own fields and familiar with Good Manufacturing The term refers to the steps you take to make sure
Practices. The members of the team may be appointed you are safe before, during and after an emergency or
from inside or outside the company. Each member shall be natural disaster. These plans are important for your safety
independent in performing the inspection and evaluation.
in both natural disasters and man-made disasters.
11.3 Coverage and Frequency of Self Inspection
Self-inspection may be conducted by part of unit Examples of natural disasters are floods, blizzards,
depending on the company requirement, however, a tornadoes and earthquakes. Man-made disasters can
complete self-inspection shall be conducted at least once a include explosions, fires, chemical and biological attacks.
year. People with disabilities may be especially
11.4 Self Inspection Report vulnerable during and after emergencies. In an emergency,
A report shall be made at the completion of a self- many systems you rely on may not function as well as they
inspection. The report shall include:
usually do. Familiar landmarks and usual travel routes you
11.4.1 self-inspection report
11.4.2 evaluation and conclusion and and your service animal know may be altered. Utilities like
11.4.3 recommended corrective actions electricity, water, gas and phone service may be disrupted.
11.5 Follow - up Action You might need to temporarily evacuate to a shelter which
may not be fully accessible for your needs. The tips and
strategies in this newsletter can help you plan to be
prepared for these situations.
Importance of Emergency Preparedness Content of an Emergency Plan
 Perform corrective actions to save lives and • Brief Process description
sufferings or injuries • Various hazards available
 Protect plant machines, equipment, buildings, loss • Classification of emergencies
of materials and properties • Emergency scenario envisaged
 Pacify dangerous/hazardous situations within • Agencies required for Emergency handling
minimum possible time • Declaration and notification of emergency
• Emergency Control center and assembly areas
Workplace Emergency • Communication facilities available
It is an unforeseen situation that threatens your • First-aid center and hospital facilities
employees, customers, or the public; disrupts or shuts • Responsibilities of key personnel/Alternate persons
down your operations; or causes physical or environmental with contact numbers.
damage. • Monitoring of hazardous chemicals.
Emergencies may be natural or manmade and include • Firefighting and rescue arrangements.
the following: • Assessment of conditions subsequent to release of
• Floods, Hurricanes, Tornadoes, Fires, Toxic gas toxic chemicals, rescue.
releases, Chemical spills, Radiological accidents, • Termination of emergency and notification of the
Explosions, Civil disturbances, Workplace violence same.
resulting in bodily harm and trauma. • Maintenance of emergency equipment.
• Surveillance and record keeping.
Types of Emergencies • Mutual aid scheme members and communication
1. On-Site Emergency system among members.
Controlling authority is General Manager • Periodicity of conducting drills/exercises
2. Off-Site Emergency
Controlling authority is District Collector Objectives of Emergency Plan

• This plan is a standing instruction for handling

Declaration of Emergency
`Emergency situations'
1. Commence • The plan envisages pooling of resources to mitigate
- Short intermittent signals 5 seconds 'ON' & 5 emergency.
seconds 'OFF' for a total period of 2 minutes. • To safe guard human beings, machines, equipment
2. Termination and property.
- A continuous signal (All clear) for 2 minutes. • To safeguard other persons not affected by
3. Emergency Announcement emergency so far.
- Emergency announcement on PA system shall • Identify/rescue casualties and arrange for their
be made in English and/or known language. treatment
• To define channels of communications with key
Means for Declaring Emergency personnel
1. Emergency Siren
- It is operated from main control room. Power
supply to the siren is class III (backed by diesel The Sectors in Emergency Response
generator). 1. Site Emergency Director
2. Public Address System Occupier/ factory manager shall be Site Emergency
- Provided at main control room and covers Director and is overall Controlling Authority.
entire plant area and buildings. Power supply to  On hearing the emergency siren or on getting
PA system is class III (backed by diesel siren or on getting information of the same, he
generator). shall proceed to the emergency control center
and take over as Site Emergency Director
Emergency Plan
 He will assess the emergency situation based
Emergency plan comes in to effect at the
upon the information and data provided.
declaration of emergency and extends up to termination of
 He will directly handle the emergency situation.
the emergency. It is applicable to all employees and
2. Advisory Group
persons available in the plant/ facility.
 Advisory group will assemble in emergency
After Bhopal gas disaster in 1984, the Factories Act
control center and advise Site Emergency
of 1948 was amended in 1987 and new provisions
Director in consultation with Shift-In-Charge
regarding safety and emergency management were added.
and damage control group.
Now it is mandatory to an organization to prepare
3. Damage Control Group
emergency preparedness plan handling hazardous
 Damage Control Group members shall
chemicals as per MSIHC rules 1989. Under the provision of
assemble immediately in main control room on
section 41B (4) of Factories Act of 1987, every occupier
hearing siren.
shall have valid emergency plan for his factory.
 Provide necessary assistance to SI to
The Regulatory Body shall formulate guidelines on
coordinate the jobs pertaining to their sections
counter measures to be taken at various intervention levels,
for combating the emergency and controlling
along with derived intervention levels in the case of off-site
the damage.
emergencies. Action plans, based on these guidelines and
 Carry out head count in their respective
other requirements in the off-site emergency plans are
sections and report missing persons to Site
described in detail in the Safety Guidelines for preparation
Emergency Director.
of emergency.
  Follow up the progress of the handling of the  All person will remain present at their work place, in
emergency case of site emergency is in local zone only and not
 Give feedback to SI or Site Emergency Director effecting health of plant employees.
for terminating the emergency as soon as the
situation eases. Tips for Workplace Emergency Response Plans
4. Station Officer  Identify Objectives
 On getting information, he will immediately o Review preparedness and response
reach the fire station/scene of fire and take planning performance objectives for your
charge of firefighting/rescue operations company or site’s program. Objectives may
depending upon the situation. include regulatory compliance, hazard
 Station Officer arrives on the scene the sub- prevention/ deterrence, risk mitigation,
officer on duty will take charge of the activities. emergency response and business
 He will ensure that necessary information is continuity.
passed on to OIECR / GSFC / IPCL (Reliance  Perform a Risk Assessment
Industries Limited) / GR / VMC fire services for o Review hazard or threat scenarios
immediate help through hot line or any identified during a risk assessment.
alternate means of communication, if  Identify Response Resources
assistance is required in his opinion. o Identify the availability and capabilities of
5. Information Officer resources to help stabilize the situation
 He will inform the officers listed under Channels including people, systems and equipment
of Communication-Intimation of Emergency within your facility, as well as external
about declaration of emergency. He is the only sources.
authorized channel through whom information  Create Incident Management Team
should be given out into public domain. o This requires response plan knowledge,
 He shall periodically collect all information, role specific training, and an effective
status of the emergency and maintain a synergy between team members and
chronological record of the events. He will be external responders.
responsible for the receipt and transmission of  Evaluate Applicable Regulations
information on the emergency and the control o Determine which response planning
measures in progress to the appropriate regulations pertain to your facility and how
authorities as per direction and advice by the you can ensure compliance within your
SED. site-specific plan.
 He will arrange for augmenting transport,  Develop Protective Action Response
ambulance, security and other facilities as Procedures
required. o Evaluate and include life protective action
6. Security Officer/Assistant Security Officer procedures such as evacuation, shelter,
 On hearing / getting information about the shelter-in-place, lockdown.
emergency, he shall restrict entry of the  Establish Hazard-Specific Response
personnel to the plant as per the directions Procedures
given by the SI / SED. o Depending upon the response planning
 He shall regulate the personnel movement into structure and required content, hazard-
the plant site and no outsiders other than fire specific information may be either
services shall be permitted through main gate. included within the response plan or
created as a separate stand-alone plan.
Emergency Control Center  Coordinate with Public Emergency Services
An emergency control center is established for use o Work with public emergency services such
during the emergency. Its location is in the General as fire, police, HAZMAT teams and
Manager s office, in technical building (housing all emergency medical services to share
communication gadgets including STD telephones, knowledge of your facility and its hazards,
wireless, GSFC telephone, HWP telephone and understand their capabilities to stabilize an
communication lists and formats and other appliances as emergency, and determine their response
listed). The meeting room in main control room will serve as time to your facility that would be needed to
the alternate Emergency Control Center. Direction of stabilize incidents at your facility.
emergency activities should be transferred from the plant
control room to emergency control center/alternate Emergency Response Training
Emergency Control Center as soon as possible to enable Training is essential so that everyone on site knows
plant operators to perform system and field operations what to do in an emergency or disruption of business
without disturbance. operations.
Training should include, but not limited to:
Assembly Point and Escape Route  Response plan familiarization
 Multipurpose hall near security gate is declared as  Individual roles and responsibilities
assembly point during emergency in the plant. All  Plan review training whenever a substantial
persons will assemble in the multipurpose hall if change or revision is made to the plan
they are asked to do so. that affects organization, procedures, roles
and responsibilities, or response capability.
 Refresher courses, as necessary
Response Drills and Exercises emphasized a total systems approach to manufacturing that
Corporate preparedness drills and exercises, which may could improve quality while lowering costs.
include fire and evacuation drills, should be designed to test HACCP was developed by the Pillsbury Company
response plan components and participants’ knowledge of while working on producing foods for NASA for use in
expectations and required duties to deploy response space missions in early 1959. NASA had concerns of food,
strategies and tactics, and restore operations. particularly crumbs, in the space capsule in zero gravity and
also food that was free of pathogens and biological toxins
Hazard Analysis and Critical Control Points (HACCP) that Pillsbury addressed by the use of HACCP. The concept
of HACCP was first presented to the public in the 1971
Hazard Analysis and Critical Control Points National Conference on Food Protection. At that time it was
based on three principles. In 1985, interest in HACCP was
The Hazard Analysis and Critical Control Points
renewed when a subcommittee of the Food Protection
(HACCP) system is a logical, scientific approach to
Committee of NASA issued a report on microbiological
controlling hazards in meat production. HACCP is a
criteria. A National Advisory Committee on Microbiological
preventive system assuring the safe production of food
Criteria for Foods was formed and that committee published
products. The application of HACCP is based on technical
a report in 1992 that provided the framework for HACCP as
and scientific principles that assure food safety. An ideal
we know it today.
application would include all processes from the farm to the
table. The principle of HACCP can be applied to production,
ADVANTAGES OF HACCP
meat slaughter and processing, shipping and distribution,
food service and in home preparation.  The HACCP system, as it applies to food safety
HACCP is a systematic preventative system that management, uses the approach of controlling
uses common sense application of scientific principles. The critical points in food handling to prevent food
most important aspect of HACCP is that it is a preventative safety problems. The system, which is science
system rather than an inspection system of controlling food based and systematic, identifies specific hazards
safety hazards. Prevention of hazards cannot be and measures for their control to ensure the safety
accomplished by end product inspection, so controlling the of food. HACCP is based on prevention and
production process with HACCP offers the best approach. reduces the reliance on end product inspection and
The application of HACCP is systematic because structured testing.
hazard analysis and implementation are provided. The
 The HACCP system can be applied throughout the
process is common sense in that each processor
food chain from the primary producer to the
understands their operation and is best able to assess
consumer. Besides enhancing food safety, other
controlling the process. HACCP is also science-based and
benefits of applying HACCP include more effective
so the controls that are placed in the process should be
use of resources, savings to the food industry and
based on scientific information.
more timely response to food safety problems.
The HACCP system has two major components:  HACCP enhances the responsibility and degree of
1. The HA of HACCP represents the logic in the control at the level of the food industry. A properly
hazard analysis which identifies the where and implemented HACCP system leads to greater
how of hazards. involvement of food handlers in understanding and
2. The CCP of HACCP represents the critical control ensuring food safety, thus providing them with
points that provide the control of the process and renewed motivation in their work. Implementing
the proof of the control. HACCP does not mean undoing quality assurance
procedures or good manufacturing practices
The end objective of HACCP is to make the product already established by a company; it does,
as safe as possible and to be able to prove that the product however, require a revision of these procedures as
was processed as safe as possible. This does not mean part of the systematic approach and for their
that HACCP provides 100% assurance of food safety to appropriate integration into the HACCP plan.
consumers, but does mean that a meat processing  The application of the HACCP system can aid
company is doing the best job possible for safe food inspection by food control regulatory authorities and
production. promote international trade by increasing buyers'
confidence. Any HACCP system should be capable
The assurance of safety comes from the process of of accommodating change, such as advances in
identifying the hazards, establishing controls for the equipment design, changes in processing
identified hazards, monitoring the controls and periodically procedures or technological developments.
verifying that the system works.
 Any HACCP system should be capable of
accommodating change, such as advances in
HISTORY OF HACCP
equipment design, changes in processing
HACCP has become synonymous with food safety.
procedures or technological developments.
It is a worldwide-recognized systematic and preventive
approach that addresses biological, chemical and physical HAZARDS
hazards through anticipation and prevention, rather than
through end-product inspection and testing. HACCP focuses on three types of hazards:
The HACCP system for managing food safety
concerns grew from two major developments. The first  biological hazards
 chemical hazards
breakthrough was associated with W.E. Deming, whose
 physical hazards
theories of quality management are widely regarded as a
major factor in turning around the quality of Japanese
products in the 1950s. Dr. Deming and others developed Biological Hazards
total quality management (TQM) systems which
 Biological hazards are the type of hazards that 5. Campylobacter
receive the most attention in the HACCP system and also  The bacteria is in the food and may become
present the greatest risk of severity and occurrence. It numerous
include hazards from pathogens such as bacteria, viruses,
 If the food is eaten, the bacteria may continue to
yeasts and molds. Bacteria that receive the greatest grow in intestines and cause illness.
attention include E. coli 0157:H7, Listeria
monocytogenes, Salmonella, Staphylococcus aureus,  #1 Cause of Food-Borne Illnesses
and Campylobacter.  Harbored in the Intestinal Tract of Animals
 Very Sensitive to Environment: Cooking, Oxygen,
1. E. coli 0157:H7
Drying
 This organism does not have to grow in food to
Campylobacter – Control
cause illness
 Low Infectious Dose  Always treat raw chicken, beef and pork as if they
are contaminated with campylobacter.
 Harbored in the Intestinal Tract of Animals: Cattle,
Sheep, Deer, other Farm Animals  Avoid eating raw or undercooked eggs.

E. coli 0157:H7 - Control  Avoid eating raw or undercooked meats (i.e.

poultry, seafood, beef, pork, etc.).
 Cooking: 160 oF for 15 Seconds
 Avoid eating raw or unpasteurized milk, cheese or
 Temperature Control: Less than 45 Less than 45- other dairy products.
40 F
 Avoid drinking untreated surface water, such as
 Fewer Cells = Less Likely to Cause Illness water from a lake or stream.
2. Listeria monocytogenes  Wash your hands with soap and water after having
contact with pet feces (i.e. after cleaning pet cages
 Concern in Processed Products: Sliced Deli Meats,
or litter boxes or picking up after a pet dog).
Hot Dogs, Soft Cheese
 Harbored in Intestinal Tract of Animals and the
Environment Chemical Hazards
 Cross Contamination from Plant Environment Chemical hazards in meat products could result
 Grows at Refrigeration Temperature from misuse of antibiotics in production, contamination with
Listeria monocytogenes – Control sanitizers or cleaning agents, or environmental
contamination from hydrolic fluids. They affect more people
 Proper Cooking than physical hazards, but typically not as many as a
 Plant Sanitation biological hazard.
 Low pH Chemicals are divided into two primary categories:
 Low Atomic weight  prohibited substances: Each company
should make certain that none of the
 Freezing prohibited substances are present in
3. Salmonella ingredients or supplies.

 All Meats can be Sources  unavoidable poisonous or deleterious

substances: They have FDA tolerance
 30% of Poultry Carry Salmonella levels or action levels, in the event that
 Some Humans are Carriers exposure or introduction is unavoidable.

 Can be found in Intestinal Tracts of Animal Products that fall into these categories include
pesticides, herbicides, growth hormones and antibiotics,
 Live Cells Must Be Consumed to Cause Illness additives and processing aids, lubricants, paints, cleaners
Salmonella – Control and sanitizers.
 Proper Cooking
Chemical hazards should be addressed in steps in
 Avoid Cross-Contamination After Cooking the production process: storage, during use (cleaning
 Use only Pasteurized Egg Products or Cook any agents, sanitizers), prior to receipt (in ingredients and
Product That has Eggs Added packaging materials), upon receipt of materials, during
 Good Personal Hygiene processing and prior to shipment of product.

4. Staphylococcus Aureus How Can Chemical Hazards Be Controlled?

 Food Intoxication  Perhaps foremost in controlling chemical

contamination are proper storage and handling
 Pathogen Must Grow in the Food and Produce practices.
Toxin
 Chemicals should be stored separately from food
 Toxin Causes Illness and is Heat Stable products and packaging materials to avoid
 Live (vegetative) Cells do NOT have to be contamination.
Consumed  Special care should be taken to thoroughly rinse
Staphylococcus Aureus – Control cleaning products and sanitizers from equipment
during clean-up, especially in areas where liquid
 Good Personal Hygiene tends to accumulate. In addition, only USDA
 Keep Foods out of the Temperature Danger Zone approved chemicals should be used during
cleaning and sanitizing.
  Pest control should be performed by professionals DEVELOPING A HACCP PLAN: THE FIVE
and chemical residues in incoming food products PRELIMINARY STEPS
should be controlled. To start a HACCP system, a company must first
write a HACCP plan. Companies may use generic models
 Other actions that may be taken include the use of
as resources for developing a plant specific plan, however,
approved chemicals only, keeping of an inventory
the most useful and successful HACCP plans need to be
of all chemicals, colorings and additives, frequent
developed from the very beginning from the plant that will
review of current procedures and formulations as
use and implement the plan. To develop a HACCP plan, a
well as audits of chemical use, adequate employee
team of individuals from within the company, with some
training and in-house testing.
assistance from outside experts, conducts five preliminary
 It is also good policy to keep up with new steps and applies the seven HACCP principles.
regulations. Pre-HACCP Step 1: Bring Together the HACCP
Resources/Assemble the HACCP Team
 The first step is to assemble the HACCP resources
Physical Hazards and team. For the development of a HACCP plan,
a meat processing company should bring together
Physical hazards are probably the most recognized as much knowledge as possible.
by consumers as they usually find this hazard. Glass,  Companies should assemble written materials and
metal, and plastic are physical hazards that can occur in company documents that relate to food safety as
meat products. well as assemble a team of individuals that
represent different segments within the industry.
 One HACCP coordinator with HACCP skills should
be appointed. HACCP skills are not necessary for
other members to be on team.
 The team should be multi-disciplinary and
represent all areas of plant such as engineering,
production, sanitation, and quality assurance.
 Some companies may consider including outside
experts from universities or trade associations.
Larger companies may develop teams of seven or
eight people while small companies may have
teams as small as two or three people.
The HACCP Coordinator should have overall responsibility
 A physical hazard is any extraneous object or
for the HACCP program and should play the role of team
foreign matter in a food item which may cause
leader. The HACCP coordinator must have management
illness or injury to a person consuming the product.
skills, must be trained in the HACCP principles and needs
 These foreign objects include, but are not limited to to have the company resources to implement HACCP.
bone or bone chips, metal flakes or fragments,
injection needles, BB's or shotgun pellets, pieces of Pre-HACCP Step 2: Describe the Product and its Method of
product packaging, stones, glass or wood Distribution
fragments, insects or other filth, personal items, or The second step is to describe completely each
any other foreign material not normally found in food product the plant makes. This can include a brief
food products. description of how the process occurs and/or how the
product is produced or prepared. This will help to focus on
 Sources for such contaminants include raw potential hazards that may occur in the product. To
materials, badly maintained facilities and describe the product, the company should answer the
equipment, improper production procedures and questions in the form below.
poor employee practices.
 Processors must determine procedures to control
physical hazards and then, during the hazard Product Category Description
analysis portion of developing a HACCP plan,
determine whether or not the severity and rate of Product:
occurrence indicate implementation of a control at The following areas need to be defined when developing
that point. the product category description.
1. Common Name/Description:
How can physical hazards be controlled? 2. Process Description:
 Control methods include raw material inspection 3. How is it to be used?
and specification, vendor certification and letters of 4. Type of Package?
guarantees, metal detectors, x-ray technology (to 5. Length of shelf-life; at what temperature?
detect bone fragments), effective pest control in the 6. Where will it be used?
facility, preventative equipment maintenance and 7. Labeling instructions:
proper sanitation procedures. 8. Is special distribution control needed?
 In addition, proper maintenance and calibration of
detection equipment is vital.
 Also important are appropriate handling of Pre-HACCP Step 3: Develop a Complete List of Ingredients
packaging material, proper shipping, receiving and and Raw Materials
storage practices as well as tamper-proof or
The third step is to develop a written list of
tamper-evident packaging.
ingredients and raw materials for each
 Equally important is employee education, since a
process/product. The ingredients and raw materials will
significant portion of items reported in food
help to focus on potential hazards in the meat product
products are personal effects dropped by
produced. Some processors have found it helpful to divide
employees.
the ingredients as indicated in the form below.
 It is also worth considering less obvious methods of
prevention like protected light fixtures and
controlling contact between pieces of machinery. Product and Ingredients
Product:
Meat Ingredients: Principle 4- Monitor CCP
Non-Meat Ingredients:
Restricted Ingredients: The HACCP team will describe monitoring
Packaging Materials: procedures for the measurement of the critical limit at each
Casing: critical control point. Monitoring procedures should describe
how the measurement will be taken, when the
measurement is taken, who is responsible for the
Pre-HACCP Step 4: Develop a Process Flow Diagram measurement and how frequently the measurement is
The next step is to construct a process flow taken during production.
diagram that identifies all the steps used to prepare the
product, from receiving through final shipment, that are Principle 5 - Establish Corrective Action
directly under the control of the processing plant. After the
flow diagram is constructed it should be verified by walking Corrective actions are the procedures that
through the plant to make sure that the steps listed on the are followed when a deviation in a critical limit occurs. The
diagram describe what really occurs in producing the HACCP team will identify the steps that will be taken to
product. prevent potentially hazardous food from entering the food
chain and the steps that are needed to correct the process.
This usually includes identification of the problems and the
Pre-HACCP Step 5: Meet the Regulatory Requirements for steps taken to assure that the problem will not occur again.
Sanitation
Good sanitation is the most basic way to ensure Principle 6 - Verification
that a safe product is produced. Maintaining good sanitation
serves as an excellent foundation for building a HACCP
Those activities, other than monitoring, that
plan. It also demonstrates that plant management has the
determine the validity of the HACCP plan and that the
commitment and resources to successfully implement the
system is operating according to the plan. The HACCP
HACCP plan. The regulatory requirement that must be met
team may identify activities such as auditing of CCP's,
in USDA inspected facilities.
record review, prior shipment review, instrument calibration
and product testing as part of the verification activities.

THE SEVEN PRINCIPLES OF HACCP

Principle 7 - Recordkeeping

The seven HACCP principles are the most

A key component of the HACCP plan is recording
important steps in writing a HACCP plan. The first two steps
information that can be used to prove that the a food was
provide the foundation for the HACCP plan. These two
produced safely. The records also need to include
steps are essential since application of the other HACCP
information about the HACCP plan. Record should include
principles depend on the results of the hazard analysis. The
information on the HACCP Team, product description, flow
remaining five steps are the application steps of the
diagrams, the hazard analysis, the CCP's identified, Critical
HACCP plan and provide the structure for conducting the
Limits, Monitoring System, Corrective Actions,
workings of the HACCP plan in the processing plant.
Recordkeeping Procedures, and Verification Procedures.

Principle 1 - Conduct a Hazard Analysis

HACCP Does not Stand Alone

The application of this principle involves listing the

The application of HACCP does not stand alone in
steps in the process and identifying where significant
a food processing facility. The plan must be built on other
hazards are likely to Occur. The HACCP team will focus on
food safety programs. Good Manufacturing Practices
hazards that can be prevented, eliminated or controlled by
(GMP) that are practiced by the processing facility will
the HACCP plan. A justification for including or excluding
support HACCP plan and will address food safety and food
the hazard is reported and possible control measures are
quality issues that are not critical for the reduction of food
identified.
safety hazards. Sanitation Standard Operating Procedures
(SSOP's) are required in federally inspected meat and
Principle 2 - Identify the Critical Control Points poultry operations and address procedures for clean
facilities, equipment and personnel that are necessary for
A critical control point (CCP) is a point, step or all products produced in a facility.
procedure at which control can be applied and a food safety
hazard can be prevented, eliminated or reduced to
acceptable levels. The HACCP team will use a CCP
decision tree to help identify the critical control points in the
process. A critical control point may control more that one
food safety hazard or in some cases more than one CCP is
needed to control a single hazard. The number of CCP's
needed depends on the processing steps and the control
needed to assure food safety.

Principle 3 - Establish Critical Limits

A critical limit (CL) is the maximum and/or minimum

value to which a biological, chemical, or physical parameter
must be controlled at a CCP to prevent, eliminate, or
reduce to an acceptable level the occurrence of a food
safety hazard. The critical limit is usually a measure such
as time, temperature, water activity (Aw), pH, weight, or
some other measure that is based on scientific literature
and/or regulatory standards.