1. Good Manufacturing Practices (GMPs)
• www.cgmp.com
• www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/gmp_e.html
• www.fda.gov/cdrh/devadvice/32.html
Premise: The chemical industry is required to follow
GMPs whenever appropriate.
Goal: Students should be able to
1) describe the nature and function of GMPs
2) describe the nature and function of GLPs
3) describe the nature and function of the ISO
2. What are Good Manufacturing Practices?
Good Manufacturing Practices (GMPs) are regulations that
describe the methods, equipment, facilities, and controls required
for producing:
• human and veterinary products
• medical devices
• processed food
The U.S. regulations are called "current" Good Manufacturing
Practices (cGMP), to emphasize that the expectations are
dynamic.
cGMPs ARE NOT OPTIONAL!
3. Why do GMPs exist?
GMPs define a quality system that manufacturers use as they
build quality INTO their products.
For example, approved drug products developed and
produced according to GMP are:
• safe
• properly identified
• of the correct strength
• pure
• of high quality
4. How were GMPs developed?
Originally, GMPs were based upon the best practices of the
industry.
As technology and practices improve, the GMPs also evolved.
In the U.S., drug cGMPs were formally introduced in 1963 and
significantly rewritten in the 1970’s.
Canadian drug GMPs existed in various forms in the 1950’s-
1970’s before being published in their current form in the
1980’s.
5. How do GMPs change?
GMPs change formally and informally.
Both the U.S. drug cGMPs and Canadian drug GMPs are
currently undergoing significant changes.
Example of formal change:
The U.S. medical device GMPs have been completely rewritten,
making them more compatible with the ISO-9001 quality
document (see www.iso.ch). In fact device GMPs were renamed
- FDA now calls them the Quality System Regulation (QSR).
6. Example of informal change:
Expectations that inspectors have evolved over time.
In the U.S., these changes are communicated by seminars and
papers presented by FDA personnel and through agency
Guides and Guidelines.
One other way industry personnel can keep track of changes in
expectations is by watching the FDA-483s (inspectional
observations) and Warning Letters issued to firms by the
agency.
7. How do GMPs of different countries
compare?
At a high level, GMPs of various nations are very similar; most
require things like:
• equipment and facilities being properly designed,
maintained, and cleaned
• Standard Operating Procedures (SOPs) be written and
approved
• an independent Quality unit (like Quality Control and/or
Quality Assurance)
• well trained personnel and management
8. Good Laboratory Practices
GLP websites:
www.fda.gov/ora/compliance_ref/bimo/7348_808/default.htm
www.scc.ca/accreditation/palcan/psa/glp_e.html
9. What are GLPs?
Good Laboratory Practice Regulations (21CFR, Part 58.
http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr58_02.html)
"to assure the quality and integrity of the test data."
All studies are performed according to basic "good practices"
including the use of
• written procedures,
• trained Associates,
• calibrated equipment,
• accredited animal facilities,
• proper data collection and storage, etc.
(Note: CFR is the Code of Federal Regulations)
10. ISO Standards
What is the ISO?
• “International Organization for Standardization”
• a network of national standards institutes of 147 countries
• a non-government organization (NGO)
• grants an ISO standard status to manufacturing companies
who voluntarily meet the requirements
What is ISO 9000?
• This standard is concerned with “quality management”
• Customer’s quality requirements, customer satisfaction,
applicable regulatory requirements, and continual improvement
are the focus of this standard.
What is ISO 14000?
• This standard is concerned with “environmental management”
• Minimizing harmful effects on the environment and continual
improvement are the focus of this standard.
