Quality Control Principle : Quality Control is concerned with sampling, specifications and testing as well as the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control … Continue reading Quality Control in Pharmaceuticals Principle and General information
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Deviation SOP and Production Interview Questions and Answers and Good Laboratory Practices (GLP)
Good Manufacturing Practices (GMP) Elements
Donation
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Amazon kindle Ebooks related to Pharmaceutical industry
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On Occasion of World Pharmacist Day
“I'm not a doctor; But patient care is my religion. A doctor's medicine saves two lives; But I fill my life with medicine by virtue of my knowledge and experience. Ability to read any doctor's prescription. Because I am a pharmacist, that is, a pharmacist. Indian philosophy says - Sarbe Bhabantu Sukhina, Sarbe Santu Niramaya... … Continue reading On Occasion of World Pharmacist Day
Drug Approval Process/Requirements for US, Europe and India
EMEA : European Medicines Evaluation Agency CHMP : Committee for Medicinal Products for Human Use TSE/BSE : Transmissible spongiform Encephalopathy/Bovine Spongiform Encephalopathy
Seven (7) Steps of CAPA Process
Let’s go through the seven steps of a CAPA implementation process. Identification ↓ Evaluation ↓ Investigation ↓ Analysis ↓ Action Plan ↓ Implementation ↓ Follow up Identification : Problem identification is the first step and plays a vital role in the success of the ongoing CAPA process. It includes identifying all the product and quality … Continue reading Seven (7) Steps of CAPA Process
Investigating and Handling of Out Of Trend (OOT) Test Results
SOP covers below points:Out of trend in pharmaDefinitions Investigation procedurePreliminary Laboratory InvestigationManufacturing InvestigationExtended Laboratory InvestigationClosure of OOT OOT FormatsInvestigation report for Out of Trend resultsChecklist for Laboratory Investigation of OOT results Flow Chart for the OOT Investigation OOT Logbook Justification for extension of OOT 1.0 OBJECTIVE : To lay down a procedure for investigating and … Continue reading Investigating and Handling of Out Of Trend (OOT) Test Results
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