CHE102

Current Good Manufacturing Practices

Good Manufacturing Practices (cGMP)

• Refer to guidelines laid down by agencies which

control authorization and licensing for manufacture
and sale of food, drug products, and active
pharmaceutical products

• These guidelines are laid down with the intention of

providing minimum requirements that a
pharmaceutical or a food product manufacturer
must meet while manufacturing drugs or food
products, which then assures that the products
manufactured/produced are of high quality and
do not pose any risk to the consumer or public.
Good Manufacturing Practices (cGMP)
Good Manufacturing Practices (cGMP)

• Good manufacturing practice guidelines

provides guidance for manufacturing, testing, and
quality assurance in order to ensure that drug
product is safe for human consumption.

• Many countries have legislated that pharmaceutical

and medical device manufacturer must follow GMP
procedures, and have created their own GMP
guidelines that correspond with their legislation.
Good Manufacturing Practices (cGMP)

• Basic concepts of all of these guidelines remain

more or less similar to the ultimate goals of
safeguarding the health of patient as well as
producing good quality medicine, medical devices
or active pharmaceutical products.

• In the U.S.A, a drug may be deemed adulterated

even though it has passed all of the specifications
tests and it is found to be manufactured in a facility
or condition which violates or do not comply with
current good manufacturing guideline. Therefore
complying with GMP is a mandatory aspect in
pharmaceutical manufacturing.
Basic Principles

• Hygiene: Pharmaceutical manufacturing

facility must maintain a clean and hygienic
manufacturing area.

• Controlled environmental conditions in order

to prevent cross contamination of drug
product from other drug or extraneous
particulate matter which may render the drug
product unsafe for human consumption.
Basic Principles

• Manufacturing processes are clearly defined

and controlled. All critical processes are
validated to ensure consistency and
compliance with specifications.

• Manufacturing processes are controlled, and

any changes to the process are evaluated.
Changes that have an impact on the quality
of the drug are validated as necessary.
Basic Principles

• Instructions and procedures are written in

clear and unambiguous language. (Good
Documentation Practices)
• Operators are trained to carry out and
document procedures.
• Records are made, manually or by
instruments, 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 drug was as expected. Deviations are
investigated and documented.
Basic Principles

• Records of manufacture (including

distribution) that enable the complete history
of a batch to be traced are retained in a
comprehensible and accessible form.

• The distribution of the drugs minimizes any

risk to their quality.

• A system is available for recalling any batch

of drug from sale or supply.
Basic Principles

• Complaints about marketed drugs are

examined, the causes of quality defects
are investigated, and appropriate
measures are taken with respect to the
defective drugs and to prevent
recurrence.
cGMP in the Philippines – AO 153
cGMP in the Philippines – AO 153

Refer to Administrative Order No. 153, S. 2004

for more details.
Other good-practice systems
1. Good laboratory practice (GLP), for laboratories
conducting non-clinical studies (toxicology and
pharmacology studies in animals);
2. Good clinical practice (GCP), for hospitals and
clinicians conducting clinical studies on new drugs in
humans;
3. Good regulatory practice (GRP), for the management
of regulatory commitments, procedures and
documentation.
4. Good Distribution Practice (GDP) deals with the
guidelines for the proper distribution of medicinal
products for human use
5. Good Transportation Practice (GTP) deals with the
guidelines for the proper domestic and international
transportation of medicinal products for human use.
What is the relevence of cGMP in
Chemical Engineering?
What is the relevence of cGMP in
Chemical Engineering?