Stamford University Bangladesh

Assignment On
“International Organization for Standardization
& Good Manufacturing Practice”
Course Title: Ethics and Regulatory Affairs
Course Code: BPH 425
Submitted To:
Name: Afia Ferdous
Designation: Assistant Professor, Dept. of Pharmacy
Stamford University Bangladesh
Submitted By:

Name ID
Sufia Akter BPH 06307213
Yeasin Chowdhury BPH 06307259
Aysha Akter BPH 06307271
Arafatunnahar Mukta BPH 06307276

Submission date: 26rd November, 2020

 International Organization for Standardization(ISO)
Introduction:
The International Organization for Standardization (ISO; /ˈaɪɛsoʊ/) is an international standard-
setting body composed of representatives from various national standards organizations.

Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial, and
commercial standards. It is headquartered in Geneva, Switzerland and works in 164 countries. was one
of the first organizations granted general consultative status with the United Nations Economic and
Social Council.

The International Organization for Standardization is an independent, non-governmental organization,

the members of which are the standards organizations of the 164 member countries. It is the world's
largest developer of voluntary international standards and it facilitates world trade by providing
common standards among nations. More than twenty thousand standards have been set, covering
everything from manufactured products and technology to food safety, agriculture, and healthcare.

Use of the standards aids in the creation of products and services that are safe, reliable, and of
good quality. The standards help businesses increase productivity while minimizing errors and waste.
By enabling products from different markets to be directly compared, they facilitate companies in
entering new markets and assist in the development of global trade on a fair basis. The standards also
serve to safeguard consumers and the end-users of products and services, ensuring that certified
products conform to the minimum standards set internationally.
History

Plaque marking the building in Prague where the ISO predecessor, the ISA, was founded

The organization began in the 1920s as the International Federation of the National Standardizing
Associations (ISA). It was suspended in 1942 during World War II, but after the war ISA was
approached by the recently formed United Nations Standards Coordinating Committee (UNSCC) with
a proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25
countries met in London and agreed to join forces to create the new International Organization for
Standardization. The new organization officially began operations in February 1947.

Name and abbreviations

The name of the organization in French is Organisation internationale de normalisation, and in

Russian, Международная организация по стандартизации (Mezhdunarodnaya organizatsiya po
standartizatsii). ISO is not an acronym. ISO gives this explanation of the name: "Because 'International
Organization for Standardization' would have different acronyms in different languages (IOS in
English, OIN in French), our founders decided to give it the short form ISO. ISO is derived from the
Greek word isos (ίσος, meaning "equal"). Whatever the country, whatever the language, the short form
of our name is always ISO. During the founding meetings of the new organization, the Greek word
explanation was not invoked, so this meaning may have been made public later, making it a backronym

Structure

ISO is a voluntary organization whose members are recognized authorities on standards, each one
representing one country. Members meet annually at a General Assembly to discuss the strategic
objectives of ISO. The organization is coordinated by a central secretariat based in Geneva
A council with a rotating membership of 20 member bodies provides guidance and governance,
including setting the annual budget of the central secretariat

The technical management board is responsible for more than 250 technical committees, who develop
the ISO standards.

IEC joint committees

ISO has formed two joint committees with the International Electrotechnical Commission (IEC) to
develop standards and terminology in the areas of electrical and electronic related technologies.

ISO/IEC JTC 1

ISO/IEC Joint Technical Committee 1 (JTC 1) was created in 1987 to develop, maintain, promote and
facilitate IT standards", where IT refers to information technology.

ISO/IEC JTC 2

ISO/IEC Joint Technical Committee 2 (JTC 2) was created in 2009 for the purpose of "standardization
in the field of energy efficiency and renewable energy sources".

Membership

ISO member countries with a national standards body and ISO voting rights
Correspondent members (countries without a national standards body)
Subscriber members (countries with small economies)

ISO has 164 national members

ISO has three membership categories

  Member bodies are national bodies considered the most representative standards body in each
country. These are the only members of ISO that have voting rights.
 Correspondent members are countries that do not have their own standards organization. These
members are informed about the work of ISO, but do not participate in standards promulgation.
 Subscriber members are countries with small economies. They pay reduced membership fees, but
can follow the development of standards.

Participating members are called "P" members, as opposed to observing members, who are called "O"
members.

ISO 9000 Quality Management Principles

 Customer focus. Understand the needs of existing and future customers. ...
 Establish a vision and direction for the organization. Set challenging goals. ...
 Engagement of people. ...
 Process approach. ...
 Improvement. ...
 Evidence-based decision making. ...
 Relationship management
.

International Standards and other publications

International standards are the main products of ISO. It also publishes technical reports, technical
specifications, publicly available specifications, technical corrigenda, and guides.

 International standards

These are designated using the format ISO[/IEC] [/ASTM] [IS] nnnnn[-p]:[yyyy] Title,
where nnnnn is the number of the standard, p is an optional part number, yyyy is the year
published, and Title describes the subject. IEC for International Electrotechnical
Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC
Joint Technical Committee). ASTM (American Society for Testing and Materials) is used for
standards developed in cooperation with ASTM International. yyyy and IS are not used for an
incomplete or unpublished standard and, under some circumstances, may be left off the title of
a published work.

 Technical reports

These are issued when a technical committee or subcommittee has collected data of a different
kind from that normally published as an International Standard, such as references and
explanations. The naming conventions for these are the same as for standards,
except TR prepended instead of IS in the report's name.

For example:

 ISO/IEC TR 17799:2000 Code of Practice for Information Security Management

 ISO/TR 19033:2000 Technical product documentation — Metadata for construction
documentation

 Technical and publicly available specifications

Technical specifications may be produced when "the subject in question is still under
development or where for any other reason there is the future but not immediate possibility of
an agreement to publish an International Standard". A publicly available specification is
usually "an intermediate specification, published prior to the development of a full
International Standard, or, in IEC may be a 'dual logo' publication published in collaboration
with an external organization". By convention, both types of specification are named in a
manner similar to the organization's technical reports.

For example:
  ISO/TS 16952-1:2006 Technical product documentation — Reference designation
system — Part 1: General application rules
 ISO/PAS 11154:2006 Road vehicles — Roof load carriers

 Technical corrigenda

ISO also sometimes issues "technical corrigenda" (where "corrigenda" is the plural
of corrigendum). These are amendments made to existing standards due to minor technical
flaws, usability improvements, or limited-applicability extensions. They are generally issued
with the expectation that the affected standard will be updated or withdrawn at its next
scheduled review.

 ISO guides

These are meta-standards covering "matters related to international standardization". They are
named using the format "ISO[/IEC] Guide N:yyyy: Title".

For example:

 ISO/IEC Guide 2:2004 Standardization and related activities — General

vocabulary
 ISO/IEC Guide 65:1996 General requirements for bodies operating product
certification
  International Standards are developed by ISO technical committees (TC) and
subcommittees (SC) by a process with six steps:

 Stage 1: Proposal stage

 Stage 2: Preparatory stage
 Stage 3: Committee stage
 Stage 4: Enquiry stage
 Stage 5: Approval stage
 Stage 6: Publication stage

The ISO Standardization Process

Each member body who has an interest in the work of a committee is entitled to be a member of that
committee. Standards are reached by consensus with each member organization representing the
interests of the vendors, manufacturers, consumers, profession als, and government of it's country.
Popular standards

Some of the most popular ISO standards for information technology include:

Open Systems Interconnection (OSI): Computer manufacturers and telecommunications providers

developed this universal reference model for communication protocols in 1983, and ISO later adopted
it as a standard.

ISO 27001: This ISO standard provides a six-step process for developing and implementing
information security policies and processes.

ISO 17799: This security management standard specifies more than 100 best practices regarding
business continuity, access control, asset management and more.

ISO 20000: This ISO standard creates a technical specification and codifies best practices for IT
service management.

ISO 31000: This risk management framework standardizes the definition of risk and associated terms
and offers guidelines for any person, business or agency

ISO 12207: This ISO standard creates a consistent lifecycle management process for all software.
 Good Manufacturing Practice (GMP)

Introduction:

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently
produced and controlled according to quality standards. It is designed to minimize the risks involved
in any pharmaceutical production that cannot be eliminated through testing the final product.

Good manufacturing practices (GMP) are the practices required in order to conform to the
guidelines recommended by agencies that control the authorization and licensing of the
manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary
supplements, and medical devices.

GMP covers all aspects of production from the starting materials, premises, and equipment to the
training and personal hygiene of staff. Detailed written procedures are essential for each process that
could affect the quality of the finished product. There must be systems to provide documented proof
that correct procedures are consistently followed at each step in the manufacturing process - every time
a product is made.

GMP is typically ensured through the effective use of a quality management system (QMS)

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers
that they must employ technologies and systems which are up-to-date in order to comply with the
regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may
have been first-rate 20 years ago may be less than adequate by current standards

Guidelines:
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality
assurance in order to ensure that a manufactured product is safe for human consumption or use. Many
countries have legislated that manufacturers follow GMP procedures and create their own GMP
guidelines that correspond with their legislation.

 Manufacturing facilities must maintain a clean and hygienic manufacturing area.

 Manufacturing facilities must maintain controlled environmental conditions in order to
prevent cross-contamination from adulterants and allergens that may render the product unsafe for
human consumption or use.
 Manufacturing processes must be clearly defined and controlled. All critical processes
are validated to ensure consistency and compliance with specifications.
 Manufacturing processes must be controlled, and any changes to the process must be evaluated.
Changes that affect the quality of the drug are validated as necessary.
 Instructions and procedures must be written in clear and unambiguous language using good
documentation practices.
 Operators must be trained to carry out and document procedures.
 Records must be made, manually or electronically, during manufacture that demonstrate that all
the steps required by the defined procedures and instructions were in fact taken and that the
quantity and quality of the food or drug was as expected. Deviations must be investigated and
documented.
 Records of manufacture (including distribution) that enable the complete history of a batch to be
traced must be retained in a comprehensible and accessible form.
 Any distribution of products must minimize any risk to their quality.
 A system must be in place for recalling any batch from sale or supply.
 Complaints about marketed products must be examined, the causes of quality defects must be
investigated, and appropriate measures must be taken with respect to the defective products and to
prevent recurrence.
Components:
To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing
attention on five key elements, which are often referred to as the 5 P's of GMP—
a. People,
b. Premises,
c. Processes,
 d. Products And
e. Procedures (Or Paperwork).

The 10 Principles of the GMP Lifestyle

 Written Procedures. The first principle of GMP is to develop detailed step-by-step procedures, in
writing, that provide a "road map" for consistency in performance. ...
 Following Procedures. ...
 Documentation. ...
 Validating Work. ...
 Facilities and Equipment. ...
 Maintenance. ...
 Job Competence. ...
 Avoiding Contamination.
 Quality Control
 Audits

MAIN RISKS WITHOUT GMP:

Unexpected contamination of products, causing damage to health or even death.

Incorrect labels on containers, which could mean that patients receive the wrong medicine.
Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

WHY GMP IS IMPORTANT?

 Government requirement

 Ensure quality product

 Reduce rejects, recalls

 Satisfied customers

 Maintain manufacturing consistency

 Company image and reputation

Final testing of the product cannot ensure the Quality efficiency and safety.

 Final testing may always not detect contamination, error, etc.

 Conformance to the predetermined specification.

 To minimize contamination eg:- microbial contamination.

 To eliminate error.

 To produce product of consistent quality.

Good Manufacturing Practices for pharmaceuticals

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently
produced and controlled according to quality standards. It is designed to minimize the risks involved
in any pharmaceutical production that cannot be eliminated through testing the final product.

Parts of GMP:
PART I
Good manufacturing practices for premises and
Materials
1. GENERAL REQUIREMENTS
1.1. Location and surroundings
The factory buildings for mfg. of drugs shall be so situated or shall have such measures
as: -
 To avoid risk of contamination from external environment.
 Any factory, which produces obnoxious odors, fumes, dust, smoke, chemical or
biological emissions.
1.2. Building and premises
The building should be designed in such a way that permits mfg. operations in hygienic
conditions.
 Compatible with other mfg. operations.
 Adequately provided with working space.
 To avoid risk of mix-ups.
 To avoid contamination.
 Designed to avoid entry of pests, birds, rodents etc. Interior surface should be
smooth and free from crakes
 The production and dispensing area shall be well lightened, ventilated, and may
have proper air handling system.
 Proper drainage system as specified for various categories of products.
 The walls and floors of mfg. area shall be free from cracks and open joints to
permit easy and effective cleaning.
1.3. Water system
 There shall be validated system for treatment of water to render it potable.
 Potable water should be used to perform all the operations except cleaning and
washing. The storage tanks shall be cleaned periodically and records maintained
by the licensee.
1.4. Disposal of waste
 The disposal of sewage and effluents shall be in conformity with the
requirements of Environment Pollution Control Board.
 All bio-medical waste shall be destroyed as per the provisions of Bio-Medical
Waste Rules, 1996.
 Record shall be maintained.
 Provision shall be made for proper storage of waste materials.

2. Warehousing area
 Adequate areas for proper warehousing of various categories of materials and
products.
 Designed and adapted to ensure good storage conditions.
 Quarantine area shall be clearly demarcated and restricted to authorized persons.
 Separate sampling area for active raw materials and excipients.

3. Production area
 Designed to allow the production preferably in uni-flow and with logical sequence
of operations.
 Separate mfg. facilities shall be provided for the mfg. of contamination causing
and potent products such as;
 β-lactam, sex hormones and cyto-toxic substance.
 Service lines shall be Well designed and constructed, shall be identified by
colours. Direction of flow shall be marked.

4. Ancillary areas
 Rest and refreshment rooms shall be separate from other areas.
Facility for changing, storing clothes and for washing and toilet purpose shall be
easily accessible and adequate.
 Areas for housing animals shall be isolated and maintained as prescribed in rule
150- C (3) of D & C Rules, 1945.
5. Quality control area
 Quality control laboratories shall be independent of the production areas.seprate
areas shall be provided each for physico-chemical, biological, micribiological or
radio –isotope analysis.
 Adequate space shall be provided to avoid mix-ups and cross contamination.
 The design of the laboratory shall take into account the suitability of construction
materials and ventilation.
 Separate air handling units and radioisotopes testing areas. The laboratory shall be
provided with regular supply of water of appropriate quality for cleaning and
testing purposes.
6. Personnel
 The manufacture and testing shall be conducted under direct supervision of
qualified technical staff.
 Personnel for QA & QC shall be qualified and experienced.
 No. of personnel employed shall be adequate and in direct proportion to the
workload.
 Personnel in production and QC lab. shall receive training appropriate to the duties
& responsibility assigned to them.
7. Health, clothing and sanitation of workers
 The personnel handling beta-lactum antibiotics shall be tested for penicillin
sensitivity before employment and those handling sex hormones, cytotoxic
substances and other potent drugs shall be periodically examined for adverse effect.
 Prior to employment, all personnel shall undergo medical examination including
eye examination, and shall be free from tuberculosis, skin and other communicable
or contagious diseases.
 Clothing:
 Protection of operator and product, highly potent products or those of particular
risk.
Need for special protective clothing.
 Personnel should not move between areas producing different products.
 Garments need to be cleaned.
 Health examinations:
On recruitment for direct operators, repeated on regular basis.
 Training: – Check Induction training for new operators includes basic personal
hygiene training.
Written procedures - to wash hands before entering a manufacturing area.
 Illness: -
Staff with illness or open lesions should not handle starting materials, intermediates or
finished products.
8. Manufacturing operations & controls
 All manufacturing operations shall be performed by trained personnel under direct
supervision of approved technical staff approved by the licensing Authority. All
the materials & containers used in mfg. process shall be conspicuously labeled
with
 Name of product
 Batch number and batch size
 Stages of manufacture
 Products not prepared under aseptic condition are required to be free from
pathogens like, Salmonella, Escherichia coli, Pyocyanea, etc.
 The licensee shall prevent mix-up and cross-contaminations of drug materials and
drug product by proper air –handling system, pressure differential, segregation,
and status labeling and cleaning. Proper records and SOPs thereof shall be
maintained.
9. Sanitation in manufacturing premises
 Manufacturing premises shall be Cleaned and maintained according to validated
cleaning procedures.
 Manufacturing areas shall not be use as storage or thoroughfare.
 A Routine sanitation program shall be drawn up and observed.
 Area shall be Well lightened production area particularly where visual on line
controls carried out.
10. Standard operating procedures (SOP), and Records , Regarding.
1. Receipt of material
Includes –
 Written SOP for receipt of raw, primary & printed packaging materials.
 Written SOP for the internal labeling, quarantine & storage of various materials.
 SOPs for related instrument & equipments.
2. Sampling
Includes –
 SOP for method of sampling.
 SOP for equipments to be used.
 Precautions to avoid contamination.
 Instruction for qty. & pooling of sample.
 Specific precautions for sampling of sterile or hazardous materials
3. Batch numbering
SOPs
 Describing the detail of batch numbering set up for each batch of intermediate,
bulk or finished product.
 Applied to a processing stage & to the respective packaging stage.
 Include date of allocation, product identity & batch size.
4. Testing: -
There shall be written procedures for testing materials and products at different
stages of manufacture, describing the methods and equipment to b e used, the tests
performed shall be recorded.

 Conclusion: Good Manufacturing Practices (GMPs) are systems created and mandated
by the government to regulate production, verification and validation of drugs, food and/or
medical devices, ensuring that finished products are effective and safe for market distribution
 References

 https://en.wikipedia.org/wiki/International_Organization_for_Standardization
 https://searchdatacenter.techtarget.com/definition/ISO
 https://www.meadmetals.com/blog/what-exactly-is-iso-certified-and-what-does-it-mean
 https://en.wikipedia.org/wiki/Good_manufacturing_practice
 https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp
 https://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/
 https://www.researchgate.net/publication/320373559_Good_manufacturing_Practice
 https://www.iso.org/home.html
 https://asq.org/quality-resources/iso-9000