Manufacturing Data

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Pharmaceutical manufacturers' compliance with cGMP and ISO standards means that manufacturing is data driven. Both sets of standards require the manufacturer to measure and document many aspects of its operation. These data are both the basis for improving the manufacturing operation and safeguarding the product, and a potential source of data for a biosurveillance system that could pay attention to a pharmaceutical table 10^1 Drugs Vulnerable To Counterfeiting

1. Combivir (lamivudine/zidovudine)

2. Crixivan (indinavir)

S. Diflucan (fluconazole)

4. Epivir (lamivudine)

5. Epogen (epoetin alfa)

6. Gamimune (globulin, immune)

7. Gammagard (globulin, immune)

8. Immune globulin

9. Lamisil (terbinafine)

10. Lipitor (atorvastatin)

11. Lupron (leuprolide)

12. Neupogen (filgrastim)

1S. Nutropin AQ (somatropin, Escherichia coli derived)

14. Panglobulin (globulin, immune)

15. Procrit (epoetin alfa)

16. Retrovir (zidovudine)

17. Risperdal (risperidone)

18. Rocephin (ceftriaxone)

19. Serostim (somatropin, mannalian derived)

20. Sustiva (efavirenz)

21. Trizivir (abacavir/lamivudine/zidovudine)

22. Venoglobulin (globulin, immune) 2S. Videx (didanosine)

24. Viracept (nelfinavir)

25. Viramune (nevirapine)

26. Zerit (stavudine)

27. Ziagen (abacavir)

28. Zocor (simvastatin)

29. Zofran (ondansetron)

50. Zoladex (goserelin)

51. Zyprexa (olanzapine)

From National Association of Boards of Pharmacy, 2004.

supply chain in ways analogous to surveillance of food supply chains.

Typically, a drug manufacturer's quality control department keeps track of incoming materials used in production. These records include information on suppliers and details on quantity and quality of raw materials received. For each incoming raw material, manufacturer often sets quality standards or "specifications'' for the required purity of the material to be supplied and the kinds and degree of acceptable impurities.

The receiving manufacturer may not test all incoming raw materials. In most cases, a manufacturer accepts raw materials based on quality assurance provided by the supplier. A supplier will submit a "certificate of analysis'' (CoA) with the materials supplied. The CoA details the quality of the raw material as analyzed by the supplier. Many raw materials arrive in several lots; each lot will arrive with its own CoA even though all are composed of the same chemical. Some suppliers will combine different lots of the same bulk chemical (chemical transported by tanker trucks or railcars) and only submit one CoA per truck or railcar. The manufacturer receiving these shipments may choose to sample the raw materials, depending on the crit-icality of the process. For high-value products, chemists will typically check these in-house and keep records. They may decide to test each of several lots separately or sample only a randomly selected portion of them. Once the manufacturer begins synthesizing intermediate products (which in turn become the ingredients used for synthesizing medicines), it will analyze the result of each synthetic step for yield, purity, physical properties (e.g., color), and types and amounts of impurities.The margin of error allowed in synthesizing pharmaceutical-grade chemicals is very small, as impurities in the API may retard effectiveness or cause adverse effects. Therefore, impurities in all steps leading to the API are also monitored closely and controlled to acceptable levels, and the manufacturer records detailed data about impurities.

The meticulous recording of data offers a way to detect the most vulnerable points of a manufacturing and supply chain to contamination or tampering. These data also represent a level of vertical organization to which the food industry could aspire, if only funding were available.

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