Tag: Regulatory Guidelines & Inspection Readiness

How to Document and Present Aseptic Process Validation to Inspectors

How to Document and Present Aseptic Process Validation to Inspectors How to Document and Present Aseptic Process Validation to Inspectors Aseptic process validation is a critical aspect of pharmaceutical manufacturing, particularly in the production of sterile products. With rigorous regulatory…

Recent FDA 483s for Aseptic Process Failures: Lessons Learned

Recent FDA 483s for Aseptic Process Failures: Lessons Learned Recent FDA 483s for Aseptic Process Failures: Lessons Learned Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment The initial phase of the validation lifecycle for aseptic processes begins with…

Preparing for an Aseptic Process Inspection: Checklist

Preparing for an Aseptic Process Inspection: Checklist Preparing for an Aseptic Process Inspection: Checklist Ensuring compliance with regulatory standards for aseptic processes is vital for pharmaceutical manufacturers. This article provides a comprehensive, step-by-step tutorial on preparing for an aseptic process…

WHO and PIC/S Guidelines on Sterile Product Validation

WHO and PIC/S Guidelines on Sterile Product Validation WHO and PIC/S Guidelines on Sterile Product Validation Step 1: Understanding the Importance of ISO 11607-2 The ISO 11607-2 standard is integral to the validation of packaging for terminally sterilized medical devices.…

Annex 1 (2023 Revision) – Key Changes for Aseptic Validation

Annex 1 (2023 Revision) – Key Changes for Aseptic Validation Annex 1 (2023 Revision) – Key Changes for Aseptic Validation The recent updates to Annex 1 for the manufacturing of sterile medicinal products have significant implications for aseptic validation practices.…

FDA Guidance on Aseptic Processing: What to Know in 2025

FDA Guidance on Aseptic Processing: What to Know in 2025 FDA Guidance on Aseptic Processing: What to Know in 2025 This comprehensive tutorial provides a step-by-step validation lifecycle for aseptic processing, focusing on the essential practices and regulatory expectations outlined…