common – Pharma GMP

Common Issues with In-Process Control of Filled Vials

digi — Mon, 24 Nov 2025 22:18:42 +0000

Common Issues with In-Process Control of Filled Vials – A Step-by-Step GMP Tutorial Common Issues with In-Process Control of Filled Vials: A Step-by-Step GMP Tutorial Ensuring the quality and safety of sterile pharmaceutical vials is a critical task in pharmaceutical manufacturing. In-process control (IPC) activities play a fundamental role during vial filling operations to monitor,...

Common Sampling Plan Deficiencies Noted by FDA Inspectors

digi — Mon, 24 Nov 2025 21:45:42 +0000

Common Sampling Plan Deficiencies Noted by FDA Inspectors Step-by-Step Guide to Identifying and Correcting Common Sampling Plan Deficiencies Noted by FDA Inspectors In pharmaceutical manufacturing, especially in the production of tablets, robust and compliant in-process sampling plans are essential for ensuring product quality and regulatory adherence. Across jurisdictions such as the US, UK, and EU,...

25 Common Documentation Errors Seen During Batch Record Review

digi — Mon, 24 Nov 2025 20:48:42 +0000

25 Common Documentation Errors Seen During Batch Record Review 25 Common Documentation Errors Seen During Batch Record Review: A Step-by-Step GMP Tutorial Batch record review is a critical quality control step in pharmaceutical manufacturing to ensure that manufacturing processes adhere strictly to Good Manufacturing Practice (GMP) standards. A compliant, accurate, and complete batch record provides...

Common GMP Manufacturing Process Control Failures and How to Prevent Them

digi — Mon, 24 Nov 2025 18:24:42 +0000

Common GMP Manufacturing Process Control Failures and How to Prevent Them Best Practices for Avoiding Common GMP Manufacturing Process Control Failures In pharmaceutical manufacturing, maintaining robust process control under Good Manufacturing Practice (GMP) guidelines is essential to ensure product quality, safety, and compliance. Regulatory authorities such as the FDA, EMA, and MHRA emphasize stringent process...