Transcript GMP, a closer look

Good Manufacturing
Practices
By: Carolina Gallango-Brun
Sana Khan
Vedrana Sahovic
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
Public Involvement
• 1905 - The Jungle by Upton
Sinclair
• Exposure of unsanitary
conditions in meat packing
plants
Fig. 2. The Jungle by Upton Sinclair
• Public awareness and
involvement
• Pure Food and Drug Act
• False labeling became illegal
Fig. 3. 1906 Meat processing plant
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
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
A Time line of GMP
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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
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
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
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
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
Provisions
21 CFR Parts 210 and 211
(Drug Industry)
21 CFR Part 820
(Medical Device Industry)
21 CFR Part 110
(Food Industry)
21 CFR Part 606
(Blood Industry)
Part 211 –Selected cGMP For
Finished Pharmaceuticals
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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.
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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.
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§ 211.25 Personnel
qualifications
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(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.
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(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.
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(c) There shall be an adequate number of qualified personnel to perform and
supervise the manufacture, processing, packing, or holding of each drug product.
• 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-tS1JUCFQM1gQod3m9cjg
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_handout.pdf
Career Opportunities
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International Quality Assurance Manager
Senior Quality Assurance Manager
Quality Assurance Associate - QA - (GMP)
Pharmaceutical - Quality Manager
GMP / GCP Manager
Packaging Operator
Line Service Operator
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.atyponlink.com/GVR/doi/abs/10.1691/ph.2008.7319?cookieSet=1&journalCode=phmz
Questions?