1. Good Manufacturing Practices
By: Carolina Gallango-Brun
Sana Khan
Vedrana Sahovic

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 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
Development of the Pure Food and Drug Act
Federal Food, Drug and Cosmetic Act
Initiation of GMP
Development of Public Health Services Act
Kefauver-Harris Drug Amendments released
Establishment of GMPs for Drugs
CGMPs for Blood and Components Final Rule
Medical Device Amendments
CGMPs for Drugs and Devices
GLPs Final Rule
Infant Formula Act is passed

7. 1941 Initiation of GMP
Sulfathiaziole tablets contaminated with phenobarbital
people died/injured
FDA to enforce and revise manufacturing and quality control requirements
GMP is born
Fig 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 Pacemaker failures reported
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
major manufacturer of infant formula reformulated two of its soy products
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

12. 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)

13. Part 211 –Selected cGMP For Finished Pharmaceuticals
Subpart E-Control of Components and Drug Product Containers and Closures
General requirements.
Receipt and storage of untested components, drug product containers, and closures.
Testing and approval or rejection of components, drug product containers, and closures.
Use of approved components, drug product containers, and closures.
Subpart F-Production and Process Controls
Written procedures; deviations.
Charge-in of components.
Calculation of yield.
Equipment identification.
Subpart A-General Provisions
Subpart B-Organization and Personnel
Responsibilities of quality control unit.
Personnel Qualifications.
Personnel responsibilities.
Subpart C-Buildings and Facilities
Ventilation, air filtration, air heating and cooling.
Maintenance
Subpart D-Equipment
Equipment design, size, and location.
Equipment construction.
Equipment cleaning and maintenance.
Automatic, mechanical, and electronic equipment.
Filters.

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

16. GMP Training GMP Training Products In-Plant Training Programs
Interactive Computer-based GMP Training
Web-based GMP Training
Public Workshops
GMP Implementation Resources

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
FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug
The Center for Professional Advancement. Good Manufacturing Practice Sep
The Power of Story Telling. A Brief History of the GMPs Aug
The New York Times Meat Processing Plant. 26 Jan Aug
Torrent Pharmaceuticals Ltd. Pharmaceutical GMP: past, present, and future–a review Aug

19. Questions?