November 21, 2018

Good Documentation Practices of BMR & BPR, Processing & Packaging Instructions,Sampling ,Testing Procedures and records. (EudraLex  Volume-4) Manufacturing Formula and Processing Instructions Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. The Manufacturing Formula should include: a) The name of the product, with a product reference […]

Generation and Control of Specifications for Intermediate, Bulk &  Finished Products  and Packaging Materials &  Retention of Documents.(EudraLex 4) All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in