Quality Assurance (QA) ensures pharmaceutical products are made and controlled according to GMP through strong systems, documentation, and compliance processes.
Introduction In the pharmaceutical industry, documentation is just as important as manufacturing. A product may be perfectly made, but if the documentation is incomplete or incorrect, the batch can be rejected. This is why Good Documentation Practices (GDP) are a fundamental part of GMP. There is a well-known saying in pharma: “If it is not […]
In the pharmaceutical industry, even a small change can affect product quality, safety, and regulatory compliance. That’s why companies follow a Change Control Procedure — a formal system to evaluate, approve, implement, and document changes in a controlled manner. Change control is not just paperwork. It is a GMP requirement that ensures any change made
Introduction The Batch Manufacturing Record (BMR) is one of the most critical documents in the pharmaceutical manufacturing process. It provides complete and traceable evidence that a batch has been manufactured, processed, and controlled in accordance with approved procedures and Good Manufacturing Practices (GMP). In pharmaceutical industries, no batch is considered complete or releasable without a
