EBR – Page 11 – Pharma GMP

GDP Errors Most Commonly Cited in FDA 483s and How to Avoid Them

November 22, 2025November 22, 2025 digi

GDP Errors Most Commonly Cited in FDA 483s and How to Avoid Them Common GDP Errors in FDA 483s and Best Practices to Prevent Them Good Documentation Practice (GDP) is essential for ensuring pharmaceutical product quality, safety, and regulatory compliance. Regulatory inspections frequently identify deficiencies related to GDP and batch records, leading to citations in…

Documentation, Batch Records & GDP

Document Hierarchy in Pharma: Policies, SOPs, Work Instructions and Records

November 22, 2025November 22, 2025 digi

Document Hierarchy in Pharma: Policies, SOPs, Work Instructions and Records Step-by-Step Guide to Document Hierarchy in Pharmaceutical Manufacturing Good documentation practice (GDP) is a cornerstone of pharmaceutical quality systems worldwide. Regulatory agencies such as FDA, EMA, MHRA, and PIC/S emphasize controlled and clearly structured GMP documentation to ensure integrity, traceability, and compliance throughout product lifecycle….

Documentation, Batch Records & GDP