GxP Insights
Impact Assessment in Cleanrooms: Practical Guid...
How to perform an effective cleanroom Impact Assessment: technical factors, real examples, mitigations and integration with OCP/CCS.
Impact Assessment in Cleanrooms: Practical Guid...
How to perform an effective cleanroom Impact Assessment: technical factors, real examples, mitigations and integration with OCP/CCS.
Operations Control Programme (OCP) for Cleanroo...
OCP ISO 14644-5:2025: structure, minimum content, QRM/CCS integration and audit readiness. Real-world examples and common inspection pitfalls.
Operations Control Programme (OCP) for Cleanroo...
OCP ISO 14644-5:2025: structure, minimum content, QRM/CCS integration and audit readiness. Real-world examples and common inspection pitfalls.
Cleaning Validation GMP: What Inspectors Look For
FDA and EMA Audits on Cleaning Validation: Requirements, Critical Documents, and Errors to Avoid
Cleaning Validation GMP: What Inspectors Look For
FDA and EMA Audits on Cleaning Validation: Requirements, Critical Documents, and Errors to Avoid
ISO 14644-5:2025: Practical Guide to Cleanroom ...
ISO 14644-5:2025 updates, OCP, risk-based approach, cleaning, monitoring, and change control. A practical approach for QA/GMP and cleanroom managers.
ISO 14644-5:2025: Practical Guide to Cleanroom ...
ISO 14644-5:2025 updates, OCP, risk-based approach, cleaning, monitoring, and change control. A practical approach for QA/GMP and cleanroom managers.
Cleaning Validation GMP: Step-by-Step Practical...
Operational Approach to GMP Cleaning Validation: MACO, Worst-Case, Sampling, and Non-Conformity Management
Cleaning Validation GMP: Step-by-Step Practical...
Operational Approach to GMP Cleaning Validation: MACO, Worst-Case, Sampling, and Non-Conformity Management
Batch Release: How QP Uses Annex 16 and QRM (An...
QP guidance on how to use Annex 16 and QRM (Annex 20) for audit-proof batch release, managing deviations, imports, and third-party audits.
Batch Release: How QP Uses Annex 16 and QRM (An...
QP guidance on how to use Annex 16 and QRM (Annex 20) for audit-proof batch release, managing deviations, imports, and third-party audits.