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QUALITY: THE BIG ( BUT RELATIVELY BRIEF ) PICTURE

Discusses quality systems in research labs, testing labs, and production facilities in the biotechnology field. Explains informal and formal quality systems, oversight, consequences of poor quality, and regulatory compliance.

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QUALITY: THE BIG ( BUT RELATIVELY BRIEF ) PICTURE

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  1. QUALITY: THE BIG (BUT RELATIVELY BRIEF) PICTURE

  2. OVERVIEW • Talk about product quality systems • In broad way • Apply ideas to the various work places we talked about

  3. QUALITY SYSTEMS • Broad systems of regulations, standards, or policies that ensure the quality of the final product

  4. Discussion of product quality and quality systems leads to… • Regulatory affairs • Interaction of government with the industry • Which for biotechnology…. • Takes us to GMP

  5. WHAT IS PRODUCT QUALITY? • What is a “good” product in biotechnology? • That depends… • Consider biotech: • Research labs • Testing labs • Production facilities

  6. QUALITY PRODUCT: RESEARCH LAB • Research lab, knowledge is product: • Knowledge of nature (basic research) • Understanding of technology (applied research, R&D)

  7. QUALITY SYSTEMS IN RESEARCH LABS • Quality system in research • Ensure meaningful data • has been around a long time • It is called:

  8. “DOING GOOD SCIENCE” • Less formalized than other quality systems • No one book spells it out • No laws to obey • But it exists

  9. INFORMAL SYSTEM • Consequences of poor quality product not life-threatening so • Government seldom involved in monitoring research quality • Oversight not generally by outside inspectors or auditors

  10. BUT THERE IS OVERSIGHT • Oversight is by peers • Grant review • Publications • Reputation

  11. CHANGE: RESEARCH LABS • Change is good • Basis for advances • Flexibility is valued • Willingness to change directions is necessary

  12. SUMMARY: RESEARCH LABS • Quality system: “Doing Good Science” • Least formal • Not found in any one book • No laws to follow • No enforcement by regulatory agency • Change is accepted • Oversight is by peers

  13. Compare and contrast situation in research labs and other work places

  14. PRODUCT QUALITY: TESTING LAB • Testing lab: • Information about samples that can be relied on when making decisions

  15. CONSEQUENCES • A poor quality product can be life-threatening or have serious effects

  16. QUALITY SYSTEMS IN TESTING LABS • Include most of what we call “doing good science” plus • Specific formal requirements • Personnel • Equipment • Training • Facilities • Documentation…

  17. You can find a book that spells it out for: • Clinical labs • Forensic labs • Environmental labs…

  18. ENFORCEMENT: TESTING LABS • Since consequences of poor product can be life-threatening • Is outside oversight • FBI • EPA • Etc.

  19. CHANGE: TESTING LABS • Change is controlled • May improve test methods, but • Test new methods against old ones • Document changes • Control change

  20. PRODUCT QUALITY: PRODUCTION FACILITY • Make tangible items • Quality means fulfill intended purpose • Ex.: reagent grade salt vs road salt vs table salt

  21. QUALITY SYSTEMS IN PRODUCTION FACILITIES • Depends on nature of product • Poor product may or may not have life-threatening consequences

  22. SO, FOR EXAMPLE • Products for research use, not generally regulated • Agricultural products are regulated in one way • Pharmaceutical products are regulated in another

  23. VOLUNTARY STANDARDS • Companies that are not regulated may choose to comply with a product quality system for business reasons

  24. ISO 9000 • ISO 9000 • Formal product quality system • Extensive • Exists in a series of books • Companies comply voluntarily to improve the quality of products • …and to make more money

  25. Developed by the International Organization for Standardization (ISO) • International

  26. OVERSIGHT: ISO 9000 • Oversight by outside auditors, paid by company

  27. CHANGE: ISO 9000 • Change is controlled • Deviations monitored • Operation of systems maintained in narrow range

  28. BIOTECH AND MEDICAL PRODUCTS • Many biotech companies that make money make medical/pharmaceutical products • Consequences of poor product can be life-threatening

  29. SO… • These products are highly regulated by the government • But, it wasn’t always this way…

  30. From http://www.fda.gov/cder/about/history/Gallery/Gallerypg.htm Gallery GuideIntroduction

  31. http://www.fda.gov/cder/about/history/Gallery/Gallerypg.htm

  32. http://www.fda.gov/cder/about/history/Gallery/Gallerypg.htm

  33. http://www.fda.gov/cder/about/history/Page6.htm

  34. http://www.fda.gov/oc/history/historyoffda/section4.html Early biomedical device

  35. “THE JUNGLE” • Upton Sinclair described shocking conditions in food industry in U.S.

  36. FEDERAL FOOD, DRUG AND COSMETIC ACT 501[351]

  37. CANNOT SELL ADULTERATED PRODUCTS “A drug or device shall be deemed adulterated – (a)1 if it consists in whole or part of any filthy…substance (2) (A) If it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth…

  38. Or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated in conformity with current good manufacturing practice to assure that such drug meets the requirements of the Act as to safety and has the identity and

  39. strength, and meets the quality and purity characteristics, which it purports or is represented to possess…”

  40. KEY IDEAS: 1906 FDCA • Adulteration • Good manufacturing practices, which we now call cGMP • FDA (Food and Drug Administration) eventually established to interpret and enforce this law

  41. SULFANILAMIDE -- 1937 • Diethylene glycol used to dissolve sulfanilamide • Hundreds of people died, mainly children

  42. First drug recall, because the drug was labeled “elixir” and had no alcohol

  43. KEY IDEAS: 1938 FDCA • Required new drugs to be shown SAFE • Eliminated requirement to prove intent to defraud in drug misbranding cases. • Extended control to cosmetics and therapeutic devices. • Authorized factory inspections…

  44. CROSS-CONTAMINATIONSULFATHIAZOLE • Nearly 300 deaths and injuries resulted from sulfathiazole tablets tainted with phenobarbital. • FDA dramatically revised manufacturing and quality controls -- good manufacturing practices (GMPs).

  45. KEY IDEAS: GMP REGULATIONS 1941 • Cover actual manufacturing • Raw materials must be good • Must have lab testing of raw materials, samples as you go along, products • Facilities, personnel, equipment must be good • Documentation

  46. Safety Testing Approval Process Revised GMP Regulations 1941

  47. THALIDOMIDE -- 1960 • Sedative that appeared safe but in reality caused severe birth defects • Thousands of children affected throughout Europe • Led to tightened laws

  48. CONTAMINATED IV BAGS --1976 • Septicemia • 1960s and 1970s there were many cases caused by IV fluids contaminated with bacteria. • Many people died

  49. FDA INSPECTIONS • Found serious problems: • Contaminated cooling water • Sterilization equipment that did not reach sterilizing temperature • Contamination

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