Regulatory Compliance Guides
Stay ahead of evolving global pharmaceutical regulations with our concise summaries and expert interpretations.
FDA 21 CFR Part 11
A checklist for ensuring data integrity in electronic records and signatures within analytical laboratory workflows. Key focus on audit trails and access control.
EU Annex 1 Revision
Summary of impact on sterile medicinal product manufacture, specifically concerning CCS (Contamination Control Strategy) for pre-filled syringes.
ICH Q1A 鈥?Q1F
Stability testing guidelines matrix for different climate zones (I-IV), including storage conditions and testing frequency recommendations.
USP <790> and <797>
Updates in visible particulate matter inspection and sterile compounding quality standards for biologic therapies.
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