GxP Insights
Cleanroom monitoring (ISO 14644-2) and 5µm mana...
How to build an audit-proof monitoring plan (ISO 14644-2). Data management, alert/action, and the challenge of particles ≥5 µm (Annex 1 2022).
Cleanroom monitoring (ISO 14644-2) and 5µm mana...
How to build an audit-proof monitoring plan (ISO 14644-2). Data management, alert/action, and the challenge of particles ≥5 µm (Annex 1 2022).
Cleaning Validation GMP: Requirements, Risks, a...
What Is Cleaning Validation GMP, What FDA and EMA Require, Common Errors, and the Impact on Quality and QA Careers
Cleaning Validation GMP: Requirements, Risks, a...
What Is Cleaning Validation GMP, What FDA and EMA Require, Common Errors, and the Impact on Quality and QA Careers
Annex 15: Practical Guide to GMP Validation and...
A step-by-step guide to Annex 15: from Validation Master Plan (VMP) to Continuous Process Verification (CPV). Learn how to implement the lifecycle.
Annex 15: Practical Guide to GMP Validation and...
A step-by-step guide to Annex 15: from Validation Master Plan (VMP) to Continuous Process Verification (CPV). Learn how to implement the lifecycle.
Cleanroom Qualification (ISO 14644-3): Guide to...
Practical guide to HVAC qualification testing (OQ/PQ) according to ISO 14644-3: HEPA filter integrity testing, smoke testing (flow visualization), recovery testing and more.
Cleanroom Qualification (ISO 14644-3): Guide to...
Practical guide to HVAC qualification testing (OQ/PQ) according to ISO 14644-3: HEPA filter integrity testing, smoke testing (flow visualization), recovery testing and more.
Annex 1 GMP 2023: Guidance on Contamination Con...
The 2023 revision of GMP Annex 1 introduces the Contamination Control Strategy (CCS). Learn what changes, the impact on QRM, and how to prepare your PQS.
Annex 1 GMP 2023: Guidance on Contamination Con...
The 2023 revision of GMP Annex 1 introduces the Contamination Control Strategy (CCS). Learn what changes, the impact on QRM, and how to prepare your PQS.
ISO 14644 and GMP Annex 1: What is the real rel...
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
ISO 14644 and GMP Annex 1: What is the real rel...
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.