Professional Documents
Culture Documents
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.
1979 - Infants diagnosed with hypochloremic metabolic alkalosis Greater regulatory control over the formulation and production of infant formula
Provisions
21 CFR Parts 210 and 211 (Drug Industry)
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.
..............
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
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 futurea review. 2008. 31. Aug. 2008. http://www.atyponlink.com/GVR/doi/abs/10.1691/ph.2008.7319?cookieSet=1&journalCode=phmz
Questions?