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Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources....
Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance...
Explore ALCOA++ in GMP: practical data integrity principles that keep records accurate, traceable, and inspection-ready....
Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing....
Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance....
Explore HEPA filter types used in pharmaceutical cleanrooms. Understand H13 vs H14, ULPA, gel-sealed filters, and Annex 1 testing requirements....
Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....
ISO 14644-1 cleanroom classification explained: particle limits, GMP grade mapping, and key compliance insights for sterile pharma manufacturing....
Learn how Quality by Design (QbD) ensures consistent pharmaceutical quality through process understanding, risk management, and regulatory alignment....
Improve supplier qualification management through practical GMP steps, detailed checklists, audits, and ongoing performance monitoring....

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