- Good Manufacturing Practices (GMP) regulations were established in the early 1900s as the pharmaceutical industry grew with no standards for product quality. GMP aims to ensure quality, safety and efficacy of drugs.
- Key events that led to strengthened GMP regulations include The Jungle exposing unsanitary meat conditions in 1905, contaminated sulfathiazole tablets killing hundreds in 1941, and the thalidomide tragedy in the 1960s from birth defects.
- Major GMP regulations and guidelines have been established by the FDA and other agencies worldwide since then to enforce manufacturing standards for facilities, equipment, components, processes, training and more.
2. The Early Beginnings
• 1900s house-calls
• Home remedies, ointments
and “miracle elixirs”
• Entertainment and music
• No regulations until 1902
Fig. 1. Animation of ancient medicine show
3. Public Involvement
• 1905 - The Jungle by Upton
Sinclair
• Exposure of unsanitary
conditions in meat packing
plants
• Public awareness and
involvement
• Pure Food and Drug Act
• False labeling became illegal
Fig. 2. The Jungle by Upton Sinclair
Fig. 3. 1906 Meat processing plant
4. What is GMP?
• Good Manufacturing
Practice 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,
and foods.
Fig.4 GMP handbooks for every industry
5. Good Manufacturing Practices
Worldwide Enforcement
• Good Manufacturing Practices are enforced in the United
States by the FDA
• In the United Kingdom by the Medicines and Healthcare
Products Regulatory Agency
• GMPs are enforced in Australia by the Therapeutically
Goods Administration
• In India by the Ministry of Health, multinational and/or
foreign enterprises
• Many underdeveloped countries lack GMPs
6. A Time line of GMP
• 1902 - Development of the Biologic Control Act
• 1906 - Development of the Pure Food and Drug Act
• 1938 - Federal Food, Drug and Cosmetic Act
• 1941 - Initiation of GMP
• 1944 - Development of Public Health Services Act
• 1962 - Kefauver-Harris Drug Amendments released
• 1963 - Establishment of GMPs for Drugs
• 1975 - CGMPs for Blood and Components Final Rule
• 1976 - Medical Device Amendments
• 1978 - CGMPs for Drugs and Devices
• 1979 - GLPs Final Rule
• 1980 - Infant Formula Act is passed
7. 1941 Initiation of GMP
• Sulfathiaziole tablets
contaminated with
phenobarbital
• 1941 - 300 people died/injured
• FDA to enforce and revise
manufacturing and quality
control requirements
• 1941 - GMP is born
Fig. 5 1906 Certificate of Purity signed by
doctor
8. 1962 Kefauver-Harris Drug
Amendments
• Thalidomide tragedy
• Thousands of children born
with birth defects due to
adverse drug reactions of
morning sickness pill taken
by mothers
• Strengthen FDA’s
regulations regarding
experimentation on humans
and proposed new way how
drugs are approved and
regulated
• “Proof of efficacy” law Fig 6. Kennedy signing the Kefauver –
Harris Drug Amendments
9. 1976 Medical Device
Amendments
• 1972 and 1973
-Pacemaker failures
reported
• 1975 - hearing-Dalkon
Shield intrauterine device
caused thousands of
injuries
• Class I, II and III medical
devices – based on
degree of control
necessary to be safe and
effective
Fig.7 President Gerald Ford signs the
Medical Device Amendments
10. 1980 Infant Formula Act
• 1978 - major
manufacturer of infant
formula reformulated two
of its soy products
• 1979 - Infants diagnosed
with hypochloremic
metabolic alkalosis
• Greater regulatory control
over the formulation and
production of infant
formula
Fig.8 Parody on Infant Formula Act
11.
12. 21 CFR Part 820
(Medical Device Industry)
21 CFR Part 110
(Food Industry)
21 CFR Part 606
(Blood Industry)
13. Part 211 –Selected cGMP For
Finished Pharmaceuticals
• Subpart A-General Provisions
• Subpart B-Organization and Personnel
• 211.22 Responsibilities of quality
control unit.
• 211.25 Personnel Qualifications.
• 211.28 Personnel responsibilities.
• Subpart C-Buildings and Facilities
• 211.46 Ventilation, air filtration, air
heating and cooling.
• 211.58 Maintenance
• Subpart D-Equipment
• 211.63 Equipment design, size, and
location.
• 211.65 Equipment construction.
• 211.67 Equipment cleaning and
maintenance.
• 211.68 Automatic, mechanical, and
electronic equipment.
• 211.72 Filters.
• Subpart E-Control of Components and
Drug Product Containers and
Closures
• 211.80 General requirements.
• 211.82 Receipt and storage of
untested components, drug product
containers, and closures.
• 211.84 Testing and approval or
rejection of components, drug product
containers, and closures.
• 211.86 Use of approved components,
drug product containers, and
closures.
• Subpart F-Production and Process
Controls
• 211.100 Written procedures;
deviations.
• 211.101 Charge-in of components.
• 211.103 Calculation of yield.
• 211.105 Equipment identification.
• ..............
14. § 211.25 Personnel
qualifications
• (a) Each person engaged in the manufacture, processing, packing, or holding of a
drug product shall have education, training, and experience, or any combination
thereof, to enable that person to perform the assigned functions. Training shall be in
the particular operations that the employee performs and in current good
manufacturing practice (including the current good manufacturing practice
regulations in this chapter and written procedures required by these regulations) as
they relate to the employee's functions. Training in current good manufacturing
practice shall be conducted by qualified individuals on a continuing basis and with
sufficient frequency to assure that employees remain familiar with CGMP
requirements applicable to them.
• (b) Each person responsible for supervising the manufacture, processing, packing,
or holding of a drug product shall have the education, training, and experience, or
any combination thereof, to perform assigned functions in such a manner as to
provide assurance that the drug product has the safety, identity, strength, quality,
and purity that it purports or is represented to possess.
• (c) There shall be an adequate number of qualified personnel to perform and
supervise the manufacture, processing, packing, or holding of each drug product.
15. • Good Manufacturing Practices (GMP) ensures quality
assurance, compliance and good product development
within the therapeutic goods industry.
• Graduate Certificate, Graduate Diploma or Master of
Science (Good Manufacturing Practices).
• GMP courses are a joint initiative
• The GMP courses are designed for people currently
working, or intending to work in the pharmaceutical or
biotechnological sectors.
• Specialization in pharmaceuticals, biologics or medical
devices
• http://www.gmptrainingsystems.com/?gclid=CKyi-t-
S1JUCFQM1gQod3m9cjg
16. GMP Training
• GMP Training Products
• In-Plant Training Programs
• Interactive Computer-based GMP Training
• Web-based GMP Training
• Public Workshops
• GMP Implementation Resources
http://www.gmptrainingsystems.com/PDF/Sample_Write_it_down_
17. Career Opportunities
• International Quality Assurance Manager
• Senior Quality Assurance Manager
• Quality Assurance Associate - QA - (GMP)
• Pharmaceutical - Quality Manager
• GMP / GCP Manager
• Packaging Operator
• Line Service Operator
18. References
Blackwell, John. 1906: Rumble Over ‘The Jungle’. 31 Aug. 2008.
http://www.capitalcentury.com/1906.html
FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug. 2008.
http://images.google.com
http://freepages.genealogy.rootsweb.ancestry.com/~myhadlfamily/hadl/hadlstories/phoeni17.
jpg
The Center for Professional Advancement. Good Manufacturing Practice. 2008. 1 Sep. 2008.
http://www.cfpa.com/gmp-training
The Power of Story Telling. A Brief History of the GMPs. 2004. 31 Aug. 2008.
http://immelresources.com/HistoryofGMPs.pdf
The New York Times. 1906 Meat Processing Plant. 26 Jan. 2005. 31 Aug. 2008.
http://www.nytimes.com/imagepages/2005/01/26/national/26meat.ready.html
Torrent Pharmaceuticals Ltd. Pharmaceutical GMP: past, present, and future–a review. 2008.
31. Aug. 2008.
http://www.atypon-link.com/GVR/doi/abs/10.1691/ph.2008.7319?
cookieSet=1&journalCode=phmz
