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What is eBMR and BMR as per PICS guideline? What is BMR? As per PICS guidelines, Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each…
Facility design and layout 1) Location and Surroundings 1.1) Preferred Location: The premises should ideally be situated in an industrial area and, under no circumstances, in residential or commercial zones. 1.2) Surrounding Environment: The premises should be located in an…
Introduction Compliance and enforcement play crucial roles in ensuring the implementation and adherence to Good Manufacturing Practices (GMP) within the manufacturing industry. GMP is a set of guidelines and regulations that govern the production, testing, and quality control of pharmaceuticals,…
1. Understanding Why GMP Compliance is Incumbent: To illustrate the importance of GMP compliance in Pharmaceuticals, let us consider a scenario involving a sterile area. Suppose there are several stages involved in producing a batch of medicine, such as sourcing…
