GAMP 5 – Concept and Implementation
The GAMP 5 life cycle is a comprehensive framework that outlines the various phases involved in the development, implementation, and maintenance of computer systems and software used in regulated industries,…
Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared…
21 CFR Part 11 : Electronic Records & Signatures
Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR…