systems – Pharma GMP

Cleaning Procedure for Coating Pans and Coating Systems

digi — Tue, 25 Nov 2025 02:33:42 +0000

Cleaning Procedure for Coating Pans and Coating Systems: A Step-by-Step GMP Guide Step-by-Step GMP Cleaning Procedure for Coating Pans and Coating Systems The pharmaceutical industry relies heavily on tablet coating operations to enhance product stability, control drug release, and improve patient acceptability. Central to this process is the coating pan and associated coating systems, which...

Risk-Based Batch Release in Modern Pharmaceutical Quality Systems

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

Risk-Based Batch Release in Modern Pharmaceutical Quality Systems Implementing Risk-Based Batch Release in Modern Pharmaceutical Quality Systems Batch release is a critical GMP activity ensuring that pharmaceutical products meet all predefined quality criteria before entering the market. In recent years, regulatory agencies including the FDA, EMA, and MHRA have encouraged adoption of risk based batch...

FDA Data Integrity Guidance: Applying Risk-Based Approaches Across Systems

digi — Sat, 15 Nov 2025 08:11:47 +0000

FDA Data Integrity Guidance: Applying Risk-Based Approaches Across Systems Implementing FDA Data Integrity Guidance Through Risk-Based System Prioritisation Data integrity remains a cornerstone of pharmaceutical quality systems globally, underpinning patient safety, product efficacy, and regulatory compliance. The FDA data integrity guidance issued in recent years emphasizes a risk-based approach to managing data through manufacturing, laboratory,...