Essay about Aseptic Processing Contamination Case S

Richard L. Friedman’s main argument in â€Å"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†¦show more content†¦The good quality of the vendor’s product can also help the customer to guarantee their finished product quality. Secondly, the rational design of validation method is very important. In the case study 1 â€Å"Aseptic Processing of a Sterile Active Pharmaceutical Ingredient (API)†, the process simulation (i.e., media fill) program was not adequately representative of the actual manufacturing process. The process simulation validation program is used to detect and diagnose an existing source of contamination. However, some companies do not realize this usage, and the process simulation validation program designed does not reflect the actual situation of production. Not just only for the simulation validation, other validations, like analysis methodology validation, equipment performance qualification, also exist this kind of problem, that is, the method used to validate/qualify does not have a sufficient sensibility and representativeness. Many engineers do not know how to design the validation method; even they do not like to perform the validation, but FDA mandates to perform validation, so some of engineers copy with it just for FDA inspection, not for keeping the quality of production. It is clear to cause the waste of manpower, material and financial resources. Good validation design cannot only help to maintain a robust qualityShow MoreRelatedAseptic Technique 14911 Words   |  20 PagesAseptic technique Michele Pearson, Leah Christine Silver, and William Jarvis Purpose Aseptic technique is employed to maximize and maintain asepsis, the absence of pathogenic organisms, in the clinical setting. The goals of aseptic technique are to protect the patient from infection and to prevent the spread of pathogens. Often, practices that clean (remove dirt and other impurities), sanitize (reduce the number of microorganisms to safe levels), or disinfect (remove most microorganisms but notRead MorePharmaeutical Industry Training Report with Deep Description of Different Area in Ibn Sina Pharmaceutical Industry Ltd.14426 Words   |  58 PagesSyrup †¢ Blending †¢ Filling B. Liquid Semisolid Department: †¢ Liquid Dosage Form †¢ Oral Liquid Processing and Filling †¢ Suspension Dosage Form †¢ Topical Ointment and filling C. Sterile Department: †¢ Ophthalmic products Read MoreIndustrial Attachment Report at Cmr-Kemri9715 Words   |  39 PagesSTERILIZATION ............3 2. MEDIA AND REAGENT PREPARATION ............................................................................5 3. SPECIMEN COLLECTION AND TRANSPORTATION ......................................................7 4. SPECIMEN PROCESSING .....................................................................................................9 1. BLOOD TESTS ............................................................................................................9 Read MoreIndian Beverage Industry Report15071 Words   |  61 Pagesproducts like milk. Commonly, drinks are filled into containers, like glass or plastic bottles, steel or aluminum cans as well as cardboard supported packages, like the TetraPak or others. Filling of beverages can be done cold, hot, ambient and cold-aseptic filling to mention the latest trend of beverage marketing and technology. The beverage is mainly categorized into two major categories based upon the alcoholic and nonalcoholic nature of the drink. Non-Alcoholic beverages are further o two types