Tag: Risk Assessment

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Featured image for change control in the pharmaceutical industry, highlighting risk-based change classification, workflow, and regulatory expectations.

Change Control in Pharmaceutical Industry

Learn how GMP change control in pharma manages modifications through risk assessment, approval, and documentation to maintain regulatory compliance....
How to write a gmp compliant user requirement specification in pharma - featured image

How to Write a GMP-Compliant User Requirement Specification (URS)

Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...
Contamination Control Strategy Featured Image

Risk-Based Contamination Control Strategy (CCS)

Learn how to build a risk-based Contamination Control Strategy (CCS) that meets Annex 1 (2022) expectations. Discover the key elements,...

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