Sumeet et al. Process validation in pharmaceutical industry: An overview. Jour. Drug Del.&Ther.; 2013; 3(4):184- 188.Sharma S, Singh G "Process validation in pharmaceutical industry: An overview" Journal of Drug Delivery & Therapeutics, 2013, 3(4): 184-188....
An Overview: The Role of Process Validation in Pharmaceutical Industry. International Research Journal of Pharmacy, 2012; 3(1): 25-27.Bala R, Kaur G, Rana AC, Seth N. The role of process validation in pharmaceutical industry. Int Res J Pharm 2012;3: 25-27....
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The present review article focus on introduction and general overview on process validation in pharmaceutical industry. The word validation simply means "A... G Kaur,AC Rana,R Bala,... - 《International Research Journal of Pharmacy》 被引量: 9发表: 2012年 Validation of Pharmaceutical Processes,...
Process validation life cycle principles1are increasingly adopted in the pharmaceutical industry to ensure robust and reproducible processes. Repeat U.S. FDA observations highlight the need to determine, better understand, and address variability within and between batches.2The criticality of process param...
Society of Pharmaceutical Sciences and ResearchWazade MB, Walde SR, Ittadwar AM. An Overview of Pharmaceutical Process Validation And Process Control Variables of Tablets Manufacturing Processes In Industry. International Journal of Pharmaceutical Sciences and Research. 2012 Sep 1;3(9):3007....
PROCESS VALIDATION IN PHARMACEUTICAL INDUSTRY: A REVIEW. Validation is a tool of quality assurance which provides confirmation of the quality in equipment system, manufacturing processes, software and testing met... Sharma,Ajay,Saini,... - 《Pharma Science Monitor》 被引量: 3发表: 2013年 Review ...
Process validation for APIs is discussed in the FDA/ICH guidance for industry, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7), available on the Internet at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Section XII of ...
Aim of the study is the Application of Process Validation approach in the Development and Scale-Up of pharmaceutical tablet dosage form of a low dose containing drug Diazepam tablet IP2 (5 mg) and a high dose-containing drug Paracetamol tablet IP 3(650 mg). Application of Process validation ...
industry, implement process validation in all your processes and you will be guaranteed of getting desired results by improving process performance and quality. It will also eliminate the chances of your products getting rejected based on several conditions. As manufacturers, you will have a thorough...