What is GMP?
⚫ GMP is a common term and its full form is Good
⚫ It is a set of regulations, codes, and guidelines for the
manufacture of drug substances and drug products,
medical devices, in vivo and in vitro diagnostic products,
⚫ GMP is that part of Quality Assurance which
ensures that medicinal products are constantly
produced and controlled to the quality
standard appropriate to their intended use.
GMP handbooks for every
It is concerned with both
Production and Quality
It’s a magic key that opens
the door to quality.
A basic tenet (principle) of GMP is that quality cannot be
tested into a batch of product but must be built
into each batch of product during all stages of
the manufacturing process.
It is designed to minimize the risks involved in
any pharmaceutical production that cannot be
eliminated through testing the final product.
Some of the main risks are;
Unexpected contamination of products, causing damage to health or
Incorrect labels on containers, which could mean that patients receive the
Insufficient or too much active ingredient, resulting in ineffective treatment
or adverse effects.
Ten Principles of GMP
1. Design and construct the facilities and equipments
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits
QA, GMP & QC inter-relationship
QA is the sum total of the organized arrangements
with the objective of ensuring that products will
be of the quality required for their intended
GMP is part of quality assurance which ensures
that medicinal products are consistently produced
and controlled to the quality standards
appropriate to their intended use.
QC is that part of GMP concerned with sampling,
specification & testing, documentation & release
procedures which ensure that the necessary & relevant
tests are performed & the product is released for use
only after ascertaining it’s quality.
What is cGMP?
cGMP refers to Current Good Manufacturing Practices
regulation enforced by USFDA
According to FDA:
the "C" in cGMP stands for "current," requiring
companies to use technologies and systems that are up-to- date
in order to comply with the regulations.
Systems and equipment that may have been "top-of-the-line"
to prevent contamination, mix-ups, and errors.
⚫ cGMP reminds manufacturer that they must
employ the technologies and systems which are up
to date in order to comply with the current
⚫ GMP has to be updated time to time in order to
comply with the standard guidelines.
⚫ cGMP is a unique term to define most recent guidelines
with improvement and additions.
⚫ Even if any product meets the specification but cGMP is not
followed, the product is then considered “adulterated” by the law.
⚫ cGMP provide for systems that assure proper design, monitoring
and control of manufacturing processes and facilities.
⚫ It is important to note that cGMPs are minimum
What is GxP?
⚫A general term for Good Practice quality guidelines and
regulations. These guidelines are used in many fields,
including the pharmaceutical and food industries.
⚫The titles of these good practice guidelines usually begin
with "Good" and end in "Practice", with the specific
practice descriptor in between
What is GxP?(continued…)
• GxP represents the abbreviations of these titles, where x
(a common symbol for a variable) represents the specific
• Good Automated Manufacturing Practice, or GaMP
• Good Clinical Practice, or GCP
• Good Distribution Practice, or GDP
• Good Documentation Practice, or GDP
• Good Laboratory Practice, or GLP
• Good Manufacturing Practice, or GMP
• Good Storage Practice, or GSP
Why cGMP is important?
⦁ cGMP is important because it is related with the well
being of human life.
⦁ A consumer usually cannot detect or understand
much about drugs which is safe or if it will
work through smell, touch, or sight
⦁ So it is the responsibility of the people involved with this
industry to produce quality and safe product and make
it available for the people.
A poor quality medicine may contain toxic substances that
have been unintentionally added.
A medicine that contains little or none of the claimed
ingredient will not have the intended therapeutic effect.
Most countries will only accept import and
sale of medicines that have been manufactured
to internationally recognized GMP
Governments seeking to promote their countries export of
pharmaceuticals can do so by making GMP mandatory for
all pharmaceutical production and by training their
inspectors in GMP requirements
Importance of cGMP(continued…)
Some recent incidents are mentioned as follows;
A Local GMP noncompliant incidence:
⦁ Paracetamol Tragedy in Bangladesh in 1991 and
⦁ Miltefosine fraud in 2008
A very recent scenario in international arena:
A British based Multinational giant Pharma has to pay $ 750
million to settle the manufacturing fraud, October, 2010.
Importance of cGMP(continued…)
GMP is important because it affects life. Some
• 1960 : The Thalidomide case in Europe…..
Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based on the
maker’s safety claims. They advertised their product as “completely safe” for everyone, including
mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to
kill a rat.” By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of
• 1970: Following the thalidomide case few regulation
were released by congress that company has to ensure
not only safety but also the efficacy of the intended use
including clinical trial reports
Importance of cGMP(continued…)
• 1980 & 1990: A 12 yrs old girl died after taking Tylenol
Acetaminophen capsule. Six other people died for the
same reason, 3 of them from the same family.
• The mfg. company recalled 32 million bottles of the
product. The investigation revealed that, a criminal
tampered had intoxicated the bottles with Cyanide
• FDA issued the tamper resistant packaging regulations
for all OTC drugs.
From the above discussion we can conclude that
Pharmaceutical Industry is regulated by GMPs
Good Manufacturing Practices must be followed
GMPs ensure drug products are safe, pure and
1. Introduction: general mechanisms of drug release from dosage forms and types of
modified release dosage forms:
2. Physicochemical &Biological Considerations in the Design of Modified Release
3. Designs, development and characterization of modified release dosage forms.
Approaches based on drug modification
Approaches Based on Dosage Form Modification
4. In vitro/In vivo evaluation of modified release dosage forms
Ancillary spaces are spaces that help support the main function of a building
The drugs, manufactured at the plant between 2001and 2005, are Kytril, Bactroban, Paxil CR and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug.