Good

Manufacturing
Practices-
GMP in Pharma
Industry
Presenter- Team-3
Date- 19 July 2020
FABRIKAM
 MEET THE TEAM

Umesh Bodhe Madhuri Yadav Shankar Nadar Santosha Kadam Oliver Antony

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Ag enda
01 What is GMP Oliver
Oliver
02 History of GMP for Pharma Oliver

03 Significance of GMP in Pharma Oliver

04 Governing Regulations Oliver

05 Principles of GMP Oliver

06 Our Team Oliver

07 Our Offices Oliver

08 Q&As Oliver

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 WHAT IS GMP?
The GMP establishes minimum standards for product manufacturing, to assist in preventing adulteration.
But more importantly, GMP needs to be a so-called “lifestyle” that each company clearly defines and
implements through its quality systems, in order to protect the safety of its customers.

WHO Definition GMP

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 Beverage industry, cosmetics, pharmaceutical products,
dietary supplements, and medical devices.

cGMP: Current Good Manufacturing Practices

Addition of current is there to signal to manufacturers that these recommendations
are updated on a regular basis. Any they need to always upgrade their Quality
Management Processes to comply to the updated guidelines.
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 HISTORY OF GMPs FOR PHARMA
1906 Pure Food and Drug Act: One of the first government regulatory agencies
made selling “adulterated” or “misbranded” food or drugs illegal
Federal Food, Drug and Cosmetic (FD&C) Act: Tragedy:107 deaths due to Sulfanilamide made with poisonous solvent
1938 Requires manufacturers to prove the safety of products before marketing

1941 Insulin Amendment to test and certify purity & potency of insulin. Revision of manufacturing and quality controls drastically
Tragedy-~300 deaths & injuries from distribution of sulfathiazole tablets tainted with phenobarbital

1962 Kefauver-Harris Drug Amendment

Tragedy: Thalidomide causes birth defects in thousands of European babies
Manufacturers must prove efficacy of products before marketing them and ensure stricter control over drug testing

1969 First Draft requirements for GMP in the manufacture and quality control of medicines and pharmaceutical specialties

1978 CGMPs Final rules for drugs and devices (21 CFR 210–211 and 820)
Established minimum current GMP for manufacturing, processing, packing, or holding drug products and medical devices

1979 GLPs Final Rule (21 CFR 58) Establishes good laboratory practices for conducting nonclinical laboratory studies that support
applications for research or marketing permits for human & animal drugs, medical devices for human use, & biological products.

1982 Tamper-resistant packaging regulations issued for OTC products

Tragedy: Acetaminophen-capsule poisoning by cyanide causes seven deaths. Millions of bottles recalled for Tylenol by J&J in US

1987 Guideline on General Principles of Process Validation Agency expectations regarding the need for process validation are outlined

1996 Revision to US CGMPs for Drugs and Biologics (21 CFR 21–211)
Added detail for validation, blend uniformity, prevention of cross-contamination, and handling out of specification results.
Draft guidance Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients and Investigating Out-of-Specification
1998 (OOS) Test Results for Pharmaceutical Production FABRIKAM 5
 WHY cGMP IS REQUIRED?
 It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks
are: 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. 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.

provide guidance for manufacturing, testing, and quality

assurance in order to ensure that a manufactured product
is safe for human consumption or use GMP helps boost pharmaceutical export opportunities
to prevent harm from occurring to the end user.
provide minimum requirements that a manufacturer must meet to assure that their
products are consistently high in quality, from batch to batch, for their intended use
makes sure that every pharmaceutical product is adequatelyensuring the end product is free from contamination, that it
tested and dosed for optimal effectiveness. is consistent in its manufacture, that its manufacture has
been well documented, that personnel are well trained,
and that the product has been checked for quality more
than just at the end phase
goal of safeguarding the health of consumers and patients as well as producing quality products. In the
United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests but
is found to be manufactured in a facility or condition which violates or does not comply with current good
manufacturing guideline.
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 BASIC PRINCIPLES?
•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.
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 MAJOR REGULATORY BODIES GOVERNING GMP
Code of Federal Regulations (CFR) Title 21
Part 314 & Part 600 -Application & licensing submission requirements for new & generic drug applicants
U.S. Food & Drug Part 210-Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs
Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals
Administration Part 11- Electronic Records & Electronic Signature Requirements

Medicines and Healthcare

Code of Federal Regulations (CFR) Title 21
Products Regulatory Agency

Central Drugs Standard

Control Organization Code of Federal Regulations (CFR) Title 21

Therapeutic Goods Code of Federal Regulations (CFR) Title 21

Administration

Code of Federal Regulations (CFR) Title 21

ANVISA- National Health
Surveillance Agency

Transnational
Standards
World Health Organization The European Union International ConferenceFABRIKAM
on Harmonization
8
• So, in short, if you want to adhere to current Good Manufacturing Practices, you need to have a quality assurance
system in place which can deal with all of the above points.

• This might seem intimidating – long words and complex sentences often have that effect – but it doesn’t have to be.

• All of this is achievable via four concepts:

• Policy: A policy is a stated aim of an organization; a principle which its operations should adhere to.

• Process: A process is a flow within an organization whereby resources or information get transformed.

• Procedure: A procedure is a specified step by step way of approaching a given task.

• Audit: An audit is an event where an organization or one of its parts is checked to see whether it meets certain
criteria.

• Combine these four concepts together effectively and you have a quality management system.

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 “
Quality is not an act,
it is a habit!
” “
-Aristotle Quality is never an accident.
It is always a result of intelligent effort!
”
-John Ruskin

ANY QUESTIONS?

THANK YOU
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