Abhimanyu et.al International Journal of Drug Regulatory Affairs.

2020; 8(4): 66-72

Available online on 15 Dec, 2020 at https://ijdra.com/index.php/journal

International Journal of Drug Regulatory Affairs

Published by Diva Enterprises Pvt. Ltd., New Delhi
Associated with Delhi Pharmaceutical Sciences & Research University
Copyright© 2013-20 IJDRA

Review Article

Good Manufacturing Practice (GMP): History, structure and its significance

Abhimanyu Rampal*, S P Yamini Kanti
Dept. of Applied Chemistry, Amity University Noida Sector-126, Uttar Pradesh, India 201301

Abstract
Good Manufacturing Practice (GMP) is set of guidelines enforced by USFDA under 21 CFR. Every Manufacturer of Food,
Cosmetics, Pharmaceuticals products, Medical Devices & Dietary products should follow these guidelines in order to be sure that their
product is safe and effective to be put in the market and for use by general population. The parameters of GMP for different Categories
may vary but there is only one aim & that is to prevent any kind of harm that can occur to the final user of the product.
Keywords: GMP, USFDA, EUROPE, CANADA, TGA, ANVISA

Article Info: Received 20 Nov. 2020; Review Completed 15 Dec. 2020; Accepted 15 Dec. 2020
Cite this article as:
Rampal A, Yamini Kanti SP. Good Manufacturing Practice (GMP): History, structure and its significance. Int J Drug
Reg Affairs [Internet]. 15 Dec 2020 [cited 15 Dec 2020]; 8(4):66-72. Available from:
http://ijdra.com/index.php/journal/article/view/439
DOI: 10.22270/ijdra.v8i4.439
*Corresponding author Tel.: +91-9953402923;
E-mail address: [email protected] (Abhimanyu Rampal).

1. Introduction of 1938 & after that, the companies for the very first
time were required to prove the safety of their
There were many tragic events happened around the
products to FDA, before marketing them directly.
world with respect to the safety & efficacy of drugs
(3)
which lead to the deaths of many people. After all these
 Case Study of 1941 – A Company introduced
incidents FDA felt the urgent need to propose some
Sulfathiazole tablets which were contaminated by
guidelines in order to ensure that the product coming to
Phenobarbital, a Sedative and with the consumption
the market and to the users should be regulated by GMP.
of this tablet nearly 300 people were killed, & with
(1)
such large no. of deaths, it persuaded FDA to make
Some of the events which led to Birth of Good’s revisions in their guidelines for Quality
Manufacturing Practices are as Mentioned below – Assurance/Control & Manufacturing. (4)
 Case Study of Thalidomide, 1957 – It was
 Case study of 1901- there were children suffering
introduced in West Germany, Europe as over the
from Diphtheria & they were given an antitoxin for
counter drug for Anxiety, Morning Sickness &
their treatment which was prepared from Horse
Trouble in Sleeping. When the Regulatory
Serum. All of the children who received that
Authorities gave Permission to sell this Drug for the
treatment died cause of Tetanus as the serum was
said symptoms, they didn’t have any idea about its
infected with Tetanus and case the led to the
side effects.
Biologics Control Act which was introduced in
 After sometime, pregnant women started consuming
1902. According to this act, it regulates the safety &
this drug for their associated Symptoms which
purity of Vaccines, Sera’s & Biological products.
further resulted in their babies were born with
(2)
deformed pair of limbs & after this incident the
 Case Study of 1937 – another tragedy happened
congress realized that this drug was Teratogenic & it
during this year, which killed almost 107 children.
was removed from the Market. (5)
An elixir formulation of Sulfanilamide was
 After all these incidents, the government came to
formulated to be used by Children for Gonorrhea &
realize that the quality & safety testing done at the
strap throat. But later, after the deaths of many
end point is not enough and the same check should
children, they discovered that liquid formulation
be done at each step so that the product meets all its
contains a poison which is was the same chemical
standards.
which is used as antifreeze and this case led to the
formation of Federal Food, Drug & Cosmetics Act
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2. Sections of GMP maintained and usage of correct materials, suitable

equipment & premises is encouraged. (6)
Before Initiating any procedure, it is required that it
should be properly defined and the necessary Pharmaceuticals GMP in India is known as Schedule M,
requirements & facilities are provided. Only trained a part of Drug & Cosmetics Act, 1940. Schedule M is
personnel should be allowed in practice, approved required to be followed by manufacturers operating
procedures should be used, Availability of storage & Pharmaceutical Manufacturing Units. Schedule M
transport facilities & proper records should be comprises of 2 parts. (7)

Well maintained Good Design Equipments

Regularly monitoring the choice of cleaning

material & equipment

Adequately trained personnel and their protective

GMP clothing

(Good Manufacturing Practices)

Important Components Maintaining Standard operating procedures and
other documentation

Quality control of Packaging, Raw materials, and

finished product

Figure 1. Important components of GMP

Part 1 – GMP for Premises & Materials  Market complaints & Adverse Reaction
It further includes: Site Master file
 General Requirements Part 1A- Requirements for Manufacturing of Parenteral
 Production area & Ophthalmic Preparations
 Ancillary area Part 1B- Requirement for Manufacturing of Oral Solid
 Personnel Dosage Form (Tablets & Capsules)
 Warehouse
 Quality Control Area Part1C- Specific Requirements for Manufacturing of
 Manufacturing operations & Controls Oral Liquids
 Health, Clothing & Sanitation of workers Part1D- Specific Requirements for Manufacture of
 Raw Material External Preparations
 Equipment
Part 2 – Requirement for Plant & Equipment (7)
 Labels & other Printed Materials
 Documentation & Records 3. General Requirements (7)
 Sanitation in the Manufacturing premises The Building & Premises which is to be used for the
 Self-inspection & internal quality audit manufacturing, processing, packaging, warehousing,
 Quality control system testing & labeling should be –
 Specifications
 Master Formula Record  Provided with adequate space to work & to
 Batch Processing Record orderly arrange all the materials & equipment &
 Packaging Record should also allow movement of personnel.
 SOPs  Compatible with the other operations that can be
carried out in the same area.
 Reference Sample
 Avoid all chances of mix-ups between different
 Reprocessing & Recovery
drugs, raw materials, intermediates, contamination
 Validation & Process Validation
& cross contamination.
 Product Recall
 The premises should be constructed in a way to
 Distribution Record prevent insects, pests, rodents & birds entry. The
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walls of the rooms should be smooth & free from  The walls & floors of the manufacturing unit
cracks and should allow easy painting and should be free from the cracks & open joints to
disinfection. avoid accumulation of dust. The walls should be
 The premises should be well Air-Conditioned in smooth so that they can be properly cleaned
all the areas where it is required, properly lighted, periodically.
ventilated & should have air handling units to  All the cleaning and painting records of the
maintain temperature, humidity inside the building should be maintained regularly.
building.
 Proper drainage system should be there in
building, open channels shall be avoided & timely
cleaning & disinfection should be done.

General requirements Production, Ancillary & Personnel, their Health, Clothing &
Warehouse Area Sanitation

Equipment, Raw materials, Quality control system and area

reference sample
Good Manufacturing
Practice (GMP)
Validation & Process Manufacturing operations & controls
Validation
Reprocessing & Recovery Sanitation in manufacturing premises

Labels & other printed materials, Documentation & records,

Product Recall
Market Complaints & Adverse Reaction Specifications, Master formula record, Batch Processing record,
Packaging record, SOPs, Site master file, Distribution Record

Figure 2. Combined components of GMP

Water System (7) There should be a separate warehouse area for raw
materials and excipient and the area must be designed so
Availability water treatment system must be there so
that there is sufficient place for different materials &
as to get purified water to carry out all the operations
products for starting & packaging materials, API &
except washing and cleaning. The water shall be stored
finished products, intermediates, products in quarantine,
in tanks and these tanks should be cleaned periodically
products released, rejected, recalled & returned spare
to ensure that water is free from any microbial growth, &
parts of machines & equipment.
records should be maintained.
Narcotics, Psychotropic drugs & substance should be
Disposal of waste (7)
stored in safe & secure areas to avoid any hazardous
The Disposal of waste from the premises should be in situation.
accordance with the requirement of Environment
Sampling & storage of sterile materials should be done
Pollution Control Board. All Bio-medical waste shall be
in Aseptic area.
destroyed as per biomedical waste Rules, 1996.
The area should be regularly checked for any kind of
There should be proper rules & provisions for the safe
leakage or breakage of containers.
storage of waste materials awaiting disposal.
All the records should be maintained from time to time.
Hazardous, flammable & toxic substance should be
stored in suitably designed areas. Ancillary Areas (7)
All the records should be maintained time to time. There should be separate rooms for Refreshment,
Rest, Changing, Storing clothes & washing for
Warehouse Area (7)
personnel’s. Toilets should be separate for males &
Warehouse area should be designed in such a way females.
that they shall be clear, dry & maintained. Temperature
These Ancillary areas should be separate from other
should be maintained at all times, the area should remain
areas & shall not lead directly to the manufacturing
free from rodents, pests, & well equipped with proper
units.
bins & platforms.

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Periodically cleaning and disinfecting records should be All the material that is received from the suppliers
maintained. should be stored separately from each other & after
checking all the materials, each one is labeled as
Quality Control Area (7)
quarantine with code no., material name, lot no. & date
These areas should be designed to avoid any kind of received. (8)
mix-ups & cross contamination, there should be proper
All the labels for quarantine, released & rejected should
space for test samples, reference standard, reagents &
be in different colors so as to avoid any kind of errors.
records.
All the equipment used for production should conform
Separate area for Physico-chemical, biological, the specified quality parameters. (9)
microbiological analysis. Periodically cleaning should be
They should be designed in a way so that it’s easy to
done. Airlocks & Laminar air flow should be there in
clean up. The material of the equipment should be well
microbiology section.
polished, smooth, no difficult corners, uneven joints, to
Personnel (7) avoid contamination & difficulty in cleaning. The
material of the equipment should be non-reactive in
All the manufacturing procedures & testing of
nature with the products so as to avoid any reaction or
products should be performed under the supervision of
contamination. Packaging material which comes in
competent technical staff, which has the required
direct contact with product should be of high grade
qualification and experience in the same. quality so that it does not cause any contamination. (10)
Staff for Quality Assurance & Quality Control section Validation (9)
should be qualified & experienced in the same. All the
duties for the technical staff & personnel responsible for Validation is an important part of GMP and it should
QA/QC shall be laid & followed by them strictly. be performed as per the protocols. All the results &
Adequate no. of personnel’s should be employed with conclusions of validation process should be recorded,
proportion to the workload in the premises documented & maintained.
Sanitation & Health (7) All the processes & procedures that had gone under
validation should be revalidated time to time to ensure
All the personnel should undergo medical
that they can give the desired results.
examination for full body; they should be free from any
diseases like skin, communicable or contagious, All the buildings & premises design should comply with
tuberculosis, before employment. the specifications of Design & they should operate in
accordance to their design specification.
A physician must be appointed for the health checkup of
all the personnel or assessing their health status. Self-Inspection & Quality Audits (7)
Staff handling the Beta-Lactum antibiotics should be A team should be made by the management including
tested for Penicillin sensitivity, & those handling staffs who are experts in their respective fields. These
cytotoxic substance, potent drugs & sex hormones teams can perform self-inspection in the production &
should be examined by physician periodically for any Quality control area time in a timely manner or on
kind of adverse effects, & these personnel should be special occasions to make sure that the manufacturer is
employed in these sections on rotation to safeguard their carrying out all the procedures in accordance with GMP.
health.
These self-inspection or quality audits can help in
All personnel should be trained well for personal detecting any shortcoming in GMP implementation &
hygiene & should be well observed if they are following corrective measures can be taken within time.
all the instructions or not. Smoking, Drinking, keeping
The procedure of self-inspection should be well
food, medicines & drinks should not be allowed in the
documented including results, conclusions, evaluation &
production, storage, laboratory & other areas.
the corrective actions.
All staff should report about their illness to their
There should be proper written instructions for –
supervisor, if they have any.
1) Premises with personnel facilities
All the premises shall be cleaned & maintained
2) Personnel
periodically to ensure that they are free from waste, dust
3) Storage facility for raw material & finished
etc.
products
There should be proper space for working & in-storage 4) Documentation
space to avoid mix-ups & contamination. 5) Quality control
6) Sanitation & Hygiene
Materials, Equipments, Packaging materials 7) Complaints
As per the starting materials specification shared by 8) Validation & Re-validation program
QC, to the purchasing department, they order materials 9) Procedures for recall
to be used for the production purpose.
Complaints & Product Recalls (7)
They usually make orders with a supplier who is
All the complaints related to the quality of the
approved by QA, QC & production department.
product must be very carefully reviewed & recorded &

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there should be a written procedure for carrying out this e) Information about any material,
process. equipment or event used.
If any serious adverse event occurs from the use of any f) Batch no. of the starting material
drug, it should be recorded & documented with the
g) Amount of product yielded at different
concerned authority.
stages of procedure
A well-structured SOP should be drafted in the premises
h) Record of all the in-process controls,
for recall of the products.
results yielded & the name of person who
All the product recalls should be documented and the carried out all of them.
necessary corrective actions are to be performed timely.
i) Record all the deviations occurred in the
Documentation (11) procedure from the master formula.
For GMP & Quality Assurance, Documentation of  Batch Packaging Record (12) - It should be in
each and every process or procedure is an important part. accordance with the packaging instructions and it
Quality Management system defines all the types of should be maintained for every batch.
Documentation required.
Before packaging each batch, it is made sure that
Through Documentation we can regulate all the the working station & the equipment is clear of the
procedures which are related to medicinal products. waste of previous the batch products
Common types of documents which are used in 4. GMP Certification Process: INDIA (13)
industries are as mentioned below-
1) Application – it’s the first step of GMP
 SOP (Standard Operating Procedures) –this is a Certification. It includes basic information of
document in which step by step instruction of all the company. The application needs to be
process and procedures are mentioned. accepted by the certification body.
 Test Method- it provides step by step instruction 2) Review of application – after receiving the
for testing materials, products, task, supplies etc. application, it should be reviewed by a team to
make sure it complies with the entire
 Policies – all the aspects of GMP o be complied by requirement.
the Manufacturer in the premises.
3) Quote & Agreement – After reviewing the
 Site Master File – it includes all the information application, the quote is provided to the clients
related to the Manufacturing site. & gap analysis is carried out so as to cover all
 Quality Handbook – it includes all the rules & the clauses & quality standard sections.
regulations which are to be followed by the 4) Documentation Review - Checking of
company. documents to make sure they comply with the
 Batch Record – it includes step by step instruction requirements.
for the entire task related to production area & these 5) Stage 1 Audit –
records are basically maintained by manufacturing
unit. 6) Review – Checking the documents, procedures
of your company in comparison to the
 Batch Processing Records – its documentation of compliance requirement.
each processed batch of the product & it complies
with the approved master formula. 7) Corrective Action – Take proper corrective
action in case of non-conformity.
1) Before processing every new batch, it should be
verified that the instrument & the working 8) Verification – Documents should be verified
station is properly clean & clear of previous according to the required standards.
products & suitable for use. 9) Stage 2 Audit –During this second audit, the
2) While processing every new batch, following auditor checks whether the company is
information should be recorded by a designated following rules & regulation according to its
person employed for the operations – documentation and if they have identified any
non-compliance, then the auditor gives an
a) Product name opportunity to the company to correct the
b) Number of the batch which is being particular non-compliance.
manufactured. 10) Review – Reviewing of the implementation of
c) Operator’s name or the person responsible regulation according to the documents of
for checking the process at each step. company.

d) Date & time of starting of any procedure, 11) Corrective Action- if they identify any non-
intermediate stage & completion of conformity, then corrective action has to be
process. taken.

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12) Verification – verify that all the rules & 15) Re-Certification –it’s done after every 3 years.
regulations are being followed by all the
- Review – review that the company
employees.
complies with the requirement of the
13) Granting of Certification – after checking all management system.
the parameters for compliance, the certification
- Corrective Action- if they identify any
body issues a certificate of compliance, valid
non-conformity, then corrective action has
for 3 years.
to be taken.
14) Surveillance Audit – After the certificate is
- Verification – compare all the company’s
issued, once in every 6 months period, a
documentation with the compliance
surveillance audit should be performed to
requirement.
ensure that the company fulfills all the
requirements of management system.
Table 1. Worldwide Agencies Regulating GMP
S. Countries with Regulatory Agencies Product to be inspected
No.
1. Canada – Health Canada API’s and Finished products (14)
2. Australia (Therapeutic Goods Administration API’s and Finished products (15)
3. Brazil ( National Agency for Sanitary Surveillance, Finished Pharmaceuticals (16)
ANVISA)
4. United States Bulk Pharmaceutical Chemicals (17)
5. Europe API’s & Finished Formulation (18)
6. United Kingdom(Medicine and Healthcare Products Finished Pharmaceuticals (19)
Regulatory Agency, MHRA)
7. South Africa (Medicines Control Council) Finished Pharmaceuticals (20)
Table 2. GMP Guidance Documents Websites
S.No. Country/Agency Website
1. Europe https://ec.europa.eu/health/documents/eudralex/vol-4_en (21)
2. United States https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-
manufacturing-practice-cgmp-regulations (22)
3. International Conference of https://www.ema.europa.eu/en/ich-q7-good-manufacturing-practice-
Harmonization active-pharmaceutical-ingredients (23)
4. The Pharmaceutical https://picscheme.org/en/activites-gmdp-harmonisation (24)
Inspection Convention and
Pharmaceutical Inspection
Co-operation Scheme (PIC/S)
5. Canada https://www.canada.ca/en/health-canada/services/drugs-health-
products/compliance-enforcement/good-manufacturing-
practices/guidance-documents/gmp-guidelines-0001/document.html (25)

5. Conclusion We would like to express our sincere gratitude to

International Journal of Drug Regulatory Affairs for
GMP is a practice for production & testing of
their continuous support and guidance.
medicinal products in order to assure that the general
population gets medicinal products of excellent quality. Financial Disclosure statement: The author received no
There have been different guidelines all over the world specific funding for this work.
for regulating the quality of medicinal products but all of
Conflict of Interest
them have the same goal of safeguarding the health of
patients as well as manufacturing good quality medicinal The authors declare that there is no conflict of
products. interest regarding the publication of this article.
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