Current Good Manufacturing
Practices
the sum total of procedures aimed at
ensuring that the products are
consistently manufactured to a quality
appropriate to their intended use
Objectives of cGMP
To minimize the risks involved in any pharmaceutical
production that cannot be eliminated through testing
the final product.
Main risks are:
- unexpected contamination of products
(causing damage to health or even death)
- incorrect labels on containers
( patients receive the wrong medicine)
- insufficient or too much active ingredient
( result in ineffective treatment or adverse effects)
Objectives of cGMP
To produce product that is
SAFE – unable to cause damage
PURE – free from contamination
EFFECTIVE – producing the
desired effect
Disadvantages of product recall
• Financial lost
• Bad publicity
• Affect the sales
• Affect the employee morale
Contamination
Particulate
Cross – contamination
Microbial
Foreign matter substances
Benefits of complying cGMP
• Assurance of product quality
• Increased company productivity
• Protection of employees and customers health
and safety
• Compliance with company policies and
procedures, government regulations and
international standards
How quality be built into the
products?
• Control of raw materials
• Control of manufacturing process
• Packaging and labelling control
• Holding and distribution control
Five Pillars of cGMP
Facilities
Traceability
Accountability
Quality Management
Validation
FACILITIES
BUILDING
Location: Protected against contamination from the
environment
Design and layout: 1. Compatible with other manufacturing
operations
2. Allow production to take place in
logical order
3. Adequate working space
4. Adequate size and appropriate for its
intended use
Construction: Well-constructed and protected against
unsanitary external environment
Maintenance: Reviewed regularly and repairs one
FACILITIES
BUILDING
Pest control Procedure: To control the infestation of
mosquitoes, houseflies, ants, cockroaches, rodents,
bed bugs, fleas and birds and to control presence of
cats and dogs.
Method of treatment:
1. Spraying
2. Dry chemical
3. Rat control
4. Use of insect killers
5. Preventing the presence of cats and dogs
6. Monitoring of bird nests
FACILITIES
BUILDING
Termite control: To prevent infestation of
termites on a weekend or during non-
productive days.
Method of treatment:
1. Perimeter treatment
2. Drilling of holes for chemical injection
3. Surface spraying with termiticide and wood
preservation
FACILITIES
EQUIPMENT
Design and Construction
– Should be of appropriate design, adequate size and
suitably located to facilities or operations for its
intended use
– Surface should not be reactive, absorptive, and
additive
– Filters for filtration used in the product manufacturing
should not release fibers
– The layout and design of equipment must aim to
minimize the risk of errors and permit effective
cleaning and maintenance
FACILITIES
EQUIPMENT
Installation and Location
– Equipment should be installed in such a way as to
minimize any risk of error or of contamination,
product mix-up and provide for easy operation and
maintenance.
– Each machine with identity numbers, tanks and pipes
are insulated to prevent injury and energy loss
– Fixed paperwork should be clearly labelled to indicate
the contents and where applicable the direction of
flow.
FACILITIES
EQUIPMENT
Maintenance and Calibration
– Conduct at appropriate intervals to prevent
malfunction and ensure that intended results are
achieved.
– With written procedures, record of usage,
maintenance and calibration are maintained.
– Immediately cleaned after each use; stored in clean
condition when not in use.
Nb. Calibration certificate
Calibration identification tag
FACILITIES
PERSONNEL
– Must be of proper mix of qualification and experience
– Of adequate number to perform the task at hand
– Trained in particular operations that the employees perform
– Properly attired
Nb. Proper laboratory attire
Should practice good sanitation and health habitS
Pass pre-employment and annual medical exam
Exclusion of personnel with apparent illness or open
lesions from direct contact with drug products,
components, and containers.
Practice personnel hygiene
TRACEABILITY
DOCUMENTATION
Four kinds of documents
• Specifications – describes in detail the requirements with which the
product, raw materials, equipments, instruments, test procedure
used or obtained have to conform
• Standard Operating Procedures – gives directions on the sequence
or course of action to be followed to carry out a specific operation
• Batch Production Record – detailed procedures for processing and
packaging of a product in its dosage form, strength, and the specific
batch size, and the quality control procedures performed
• Records (logbooks, notebooks, inventory stock cards, forms) –
provide the history of each batch product
TRACEABILITY
DOCUMENTATION
Method of documentation
• Written clearly, accurately, and contain
detailed description to prevent
misinterpretation
• Written in plain English that can be easily
understood by the user
• In imperative mood and sequential steps
TRACEABILITY
DOCUMENTATION
• Record all necessary information immediately upon completion of
task
• Signatures/initials shall be similar from specimen signature
• Permanent blue ink shall be used
• Unauthorized personnel shall not sign for another
• When procedure is not applicable “Not Applicable” “NA” shall be
written”
• Raw data shall be recorded in logbooks, notebooks, or forms, not in
loos sheets of paper
• Don’t assume that undocumented work has been properly
completed
• No alteration shall be made on approved documents
• Provision of preventing the use of superseded documents
TRACEABILITY
MATERIALS / PRODUCT
1. With inventory system
2. Identification of materials and products
stored
3. Rejected materials/products
4. Returned materials/products
ACCOUNTABILITY
• No missing materials/products
• After each processing or packaging operations,
the total amount of product yield should be
accounted for
• Rework operations
• Personnel responsibilities
• Signatures of people concerned in each operation
during manufacture and distribution should
appear on all records and documentation
QUALITY MANAGEMENT
• In-process Quality Control Test
• Finished Product Quality Control Test
• Internal Audit – quality inspection of personnel,
premises, equipment, sanitation and hygiene,
purchasing, production, quality control,
engineering, research and department, holding
and distribution, documents and depots to
identify problems within the company to verify
by inspection the compliance of the subjects to
the SOPs and GMP
QUALITY MANAGEMENT
Classification of Findings
• Critical observation: an observation which has produced or leads to
significant risk of producing a product that is harmful to the human
patient (24 hours)
• Major observation: a non-critical observation, which has produced
or might produce a product which would not comply with the
marketing authorization, a major deviation from good
manufacturing practice regulations, or a combination of several
minor deficiencies (7 days)
• Minor observation: an observation which cannot be classified as
critical or major, but indicates a departure from good
manufacturing practice or internal SOP. The observation does not
have a major impact on the quality of the product (30 days)
Nb. Corrective Action / Preventive Action
QUALITY MANAGEMENT
• External Audit
• Product Complaint – a complaint is when a customer
or any other (internal or external party) has reported
product defects, adverse effects, or serious adverse
events with any of the company’s marketed products
Defective product
– proved to be harmful under conditions of use
– lacking in quality, safety, and efficacy
– the qualitative and quantitative composition of the product is not as
declared
– visual defects that is inconsistent with the products specifications
– the manufacturing process has not been fulfilled
• Product Stability Testing – a test conducted on raw
materials and finished products to determine the
storage conditions, re-test procedures and shelf-life of
the product
VALIDATION
the action of approving materials, process,
procedure, activity, system, equipment, and
mechanism used in manufacturing has
consistently achieved the desired result
