Regulatory Guidelines & Inspection Readiness

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…

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.…

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.…

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…

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…

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…

Cleanroom Behavior Training and Regulatory Expectations

Cleanroom Behavior Training and Regulatory Expectations Cleanroom Behavior Training and Regulatory Expectations This article provides a comprehensive, step-by-step tutorial on validation in cleanroom environments, particularly focusing on cleanroom class 1 settings. Designed for QA, QC, and Validation teams within the…

Regulatory Emphasis on Contamination Control Strategy (CCS)

Regulatory Emphasis on Contamination Control Strategy (CCS) Regulatory Emphasis on Contamination Control Strategy (CCS) As the pharmaceutical industry continues to evolve, the emphasis on effective contamination control strategies (CCS) remains paramount, especially in sterile manufacturing. The guidelines provided by Eudralex…

How to Handle Media Fill Failures During an Inspection

How to Handle Media Fill Failures During an Inspection How to Handle Media Fill Failures During an Inspection In the pharmaceutical industry, ensuring the integrity of aseptic processes is critical. Media fill tests are essential components of process validation, particularly…

Audit-Ready Documentation Flow for Aseptic Validation

Audit-Ready Documentation Flow for Aseptic Validation Audit-Ready Documentation Flow for Aseptic Validation Step 1: User Requirements Specification (URS) and Risk Assessment The foundation of any validation effort is the User Requirements Specification (URS). The URS outlines the specific requirements that…