PIC/S GMP Annex 1 vs EU Annex 1: Key Differences
PIC/S GMP Annex 1 is the PIC/S version of the sterile manufacturing annex, identical to the EU text apart from minor wording differences. Here are the joint revision...
Read the article →GXP ACADEMY · PIC/S GUIDELINES
PIC/S Guidelines: understand inspection expectations, prepare robust evidence.
Practical analysis of the PIC/S GMP Guide, Aide-Mémoires and PI documents: Pharmaceutical Quality Systems, Data Integrity, sterile manufacturing, deviations, CAPA and self-inspection. Built to use PIC/S as an inspection framework and turn expectations into verifiable controls.
✓ PIC/S GMP Guide
✓ Aide-Mémoire · PI documents
✓ Inspection readiness
PIC/S · AUDITS · GMP INSPECTIONS
Prepare for inspections by starting with what is actually checked.
PI documents, PQS, internal audits, Data Integrity, CAPA and inspection readiness explained through concrete criteria and control points.
PIC/S PI 041-1: The Data Integrity and Data Management Guide
PIC/S PI 041-1 is the reference guidance on data management and data integrity in GMP and GDP environments: 63 pages telling inspectors what to look at, from data...
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PIC/S PE 009-18: What Changed in the Revised GMP Guide
PIC/S PE 009-18 is the revision of the GMP Guide in force since 24 September 2026: it incorporates the revised Annex 19 on reference and retention samples, with...
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PIC/S GMP Guide Part 2: API Requirements Explained
The PIC/S GMP Guide Part 2 sets out the GMP requirements for API manufacturing, mirroring ICH Q7. We cover scope, the 20-chapter structure, the API Starting Material concept...
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PIC/S vs EU GMP vs WHO: Key Differences Explained
What is the difference between PIC/S, EU GMP and WHO guidelines? A practical comparison of the three GMP frameworks: nature, legal status, structure, annexes and inspections, with a...
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PIC/S PI and GMP Audits: What Inspectors Really Look For
What inspectors verify using PIC/S PI documents during GMP inspections and how to avoid critical deviations.
Read the article →PICS - Guidelines
PIC/S GMP Annex 1 vs EU Annex 1: Key Differences
PIC/S GMP Annex 1 is the PIC/S version of the sterile manufacturing annex, identical to the EU text apart from minor wording differences. Here are the joint revision timeline, the...
PIC/S GMP Annex 1 vs EU Annex 1: Key Differences
PIC/S GMP Annex 1 is the PIC/S version of the sterile manufacturing annex, identical to the EU text apart from minor wording differences. Here are the joint revision timeline, the...
PIC/S PI 041-1: The Data Integrity and Data Man...
PIC/S PI 041-1 is the reference guidance on data management and data integrity in GMP and GDP environments: 63 pages telling inspectors what to look at, from data governance to...
PIC/S PI 041-1: The Data Integrity and Data Man...
PIC/S PI 041-1 is the reference guidance on data management and data integrity in GMP and GDP environments: 63 pages telling inspectors what to look at, from data governance to...
PIC/S PE 009-18: What Changed in the Revised GM...
PIC/S PE 009-18 is the revision of the GMP Guide in force since 24 September 2026: it incorporates the revised Annex 19 on reference and retention samples, with a rewritten...
PIC/S PE 009-18: What Changed in the Revised GM...
PIC/S PE 009-18 is the revision of the GMP Guide in force since 24 September 2026: it incorporates the revised Annex 19 on reference and retention samples, with a rewritten...
PIC/S GMP Guide Part 2: API Requirements Explained
The PIC/S GMP Guide Part 2 sets out the GMP requirements for API manufacturing, mirroring ICH Q7. We cover scope, the 20-chapter structure, the API Starting Material concept and the...
PIC/S GMP Guide Part 2: API Requirements Explained
The PIC/S GMP Guide Part 2 sets out the GMP requirements for API manufacturing, mirroring ICH Q7. We cover scope, the 20-chapter structure, the API Starting Material concept and the...
PIC/S vs EU GMP vs WHO: Key Differences Explained
What is the difference between PIC/S, EU GMP and WHO guidelines? A practical comparison of the three GMP frameworks: nature, legal status, structure, annexes and inspections, with a comparison table...
PIC/S vs EU GMP vs WHO: Key Differences Explained
What is the difference between PIC/S, EU GMP and WHO guidelines? A practical comparison of the three GMP frameworks: nature, legal status, structure, annexes and inspections, with a comparison table...
PIC/S PI and GMP Audits: What Inspectors Really...
What inspectors verify using PIC/S PI documents during GMP inspections and how to avoid critical deviations.
PIC/S PI and GMP Audits: What Inspectors Really...
What inspectors verify using PIC/S PI documents during GMP inspections and how to avoid critical deviations.
