WHO GMP documentation – Pharma GMP

Electronic Batch Records (EBR) vs Manual: GMP Pros and Cons

digi — Fri, 12 Sep 2025 18:15:03 +0000

Electronic Batch Records (EBR) vs Manual: GMP Pros and Cons Electronic Batch Records vs Manual Systems: Pros and Cons for GMP Compliance Introduction: Why This Topic Matters for GMP Compliance Batch records are central to demonstrating Good Manufacturing Practice (GMP) compliance. They document every stage of drug production, packaging, and quality control, serving as proof...

How to Build a GMP-Compliant Documentation System

digi — Fri, 05 Sep 2025 21:26:59 +0000

How to Build a GMP-Compliant Documentation System Step-by-Step Guide to Building a GMP-Compliant Documentation System Introduction: Why This Topic Matters for GMP Compliance In the pharmaceutical industry, documentation is often referred to as the backbone of Good Manufacturing Practice (GMP). Regulators such as the FDA, EMA, and WHO emphasize that if a process or activity...

Documentation Standards for WHO GMP Compliance

digi — Thu, 29 May 2025 21:12:18 +0000

Documentation Standards for WHO GMP Compliance Mastering Documentation Standards for WHO GMP Compliance Documentation is the cornerstone of Good Manufacturing Practices (GMP), providing verifiable evidence of quality, consistency, and compliance. In the context of the WHO Prequalification Programme (PQP), manufacturers must meet rigorous documentation standards to obtain and maintain compliance. This article explores the critical...

WHO Site Master File Requirements for GMP Prequalification

digi — Mon, 26 May 2025 22:56:27 +0000

WHO Site Master File Requirements for GMP Prequalification WHO Site Master File Requirements for GMP Prequalification The Site Master File (SMF) is a foundational document required during the WHO GMP prequalification process. It provides a comprehensive overview of a pharmaceutical manufacturing site’s quality system, infrastructure, operations, and compliance framework. As a core submission component under...