Richard L. Friedman’s main argument in “Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System” is: The author concludes that the sterile dosage form contamination issues can emerge in the deficient design concepts and the daily operations of the pharmaceutical industry determine safety and efficacy of drug products by analysis of 8 case studies. In this paper, the following system deficiencies are mentioned: production system, packaging and labeling system, facilities and equipment system, material system, and lab control. What I learnt from this paper is the importance of supplier audit, rational design of validation method and facilities design.
Firstly, supplier audit is important. Although the author just mentioned it in the case study 5 “Parenteral-Grade Drug Substance Pyrogenicity”, I think the supplier audit deficiency is also involved in the case study 3 “Modified 0.2-micron Filter Design and Change Control Systems”. In the case study 3, the customers have been notified the change control of the vendor, and the vendor told them the change is minor. I think the customers did not focus more on this change control and did not assess the impact of the change control to their production. Therefore they continue purchasing and using the filter of this vendor. In the case study 5, the API manufacturer had numerous quality problems, especially there is no equipment usage log for some equipment and this is an obvious deficiency. I believe that these problems have been existed for a long time. If the customers can conduct an effective audit of a vendor’s facility, they will refuse to purchase the API from this vendor, and then numerous adverse reactions did not occurred. I found that supplier audit for some companies are formalization. The vendor does not like to be audited, so they just provide the superficial things to the customer. The customer is being hindered and just focus more on the price than on the quality. In my...
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