Gmp

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

• 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

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 • 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

• Modification of industry’s and FDA’s recall procedures

Fig.8 Parody on Infant Formula Act

Provisions21 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

• 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.

• ..............

§ 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.

• 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

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• 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.atypon-link.com/GVR/doi/abs/10.1691/ph.2008.7319?cookieSet=1&journalCode=phmz

Questions?