SOP on Good Laboratory Practices as per schedule L1
Good laboratory practices need to be performed in the laboratory for consistent, reliable analytical results. This SOP introducing about Good …
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SOP on Site Master File (SMF) and How to prepare Site Master File as per guideline
Standard operating procedure on Site Master File (SMF) is describes, What is a site master file and what are the requirements of the …
What is the risk and How to minimize the risk of TSE (Transmissible Spongiform Encephalopathy) / BSE (Bovine Spongiform Encephalopathy)
What is Transmissible Spongiform Encephalopathy (TSE) / Bovine Spongiform Encephalopathy (BSE). How to minimize the risk of TSE/BSE in pharmaceuticals. …
Role and Responsibility of Production unit and Quality unit
Describing what is the key role and responsibility of production and quality units? This helps to avoid misunderstandings between the …
Data Integrity, ALCOA+, Common Issue of Data Integrity and How to minimize the risk of Data Integrity, Procedure for correction of Data Integrity issues
Data integrity is one of the most serious issues that most pharmaceutical companies are facing. Here, we are going to …
What is ALCOA+ (plus) / ALCOA+ details / ALCOA+ Principle
ALCOA+ is an acronym used for data integrity purposes. This article introduces the Origin of ALCOA+, what is ALCOA+, and the term ALCOA+. …
Terminology Done by, Prepared by, Checked by, Verified by, Reviewed by, Approved by
Explaining below terminology which is commonly used in the pharmaceuticals and difference between Done by/Performed By, Prepared By, Checked By / Witnessed …