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ICH Q3E draft outlines global guidance for Extractables & Leachables, covering scope, risk assessment, AET, and regulatory expectations....
Annex 22 - EU's new draft regulatory framework for AI in GMP, focusing on model validation, performance, and risk management...
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....
IDMP Ontology explained: how it supports regulatory data, improves data governance, and prepares your pharma organization for SPOR and ISO...
Explore the critical role of Clean Hold Time (CHT) and Dirty Hold Time (DHT) in cleaning validation. This in-depth guide...
GMP vs cGMP—understand what “current” means for today’s quality standards, compliance expectations, and pharma manufacturing practices...
The 2025 EU GMP draft revisions to Chapter 4, Annex 11, and Annex 22 bring major changes to documentation, computerized...
Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control....
USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations....

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