PIC/S PE009-18: What’s New in the Latest GMP Guide — And How It Compares to PE009-16
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) continues to enhance global GMP standards through its evolving guide. While Australia currently enforces PE009-16 (as of February 2022), the most recent PIC/S version is PE009-18, adopted internationally by some regulatory bodies from 1 February 2022.
So, what’s changed in PE009-18, and how does it compare to PE009-16? Let’s break it down for quality professionals, manufacturers, and consultants keeping an eye on future compliance trends.
What Is PIC/S PE009-18?
PE009-18 is the latest revision of the PIC/S Guide to GMP for Medicinal Products, incorporating updates to support:
- Risk-based manufacturing oversight
- Enhanced data integrity
- Revised Annex structures
- Alignment with EU GMP updates and ICH Q series guidelines
PE009-18 vs PE009-16 — Key Differences at a Glance
| Focus Area | PE009-16 | PE009-18 |
|---|---|---|
| Annex 1 - Sterile Manufacturing | Legacy version | Refreshed version adopted (2023): heavy focus on Contamination Control Strategy (CCS) |
| QRM (Quality Risk Management) | Stronger focus added | Expanded integration across entire lifecycle (aligned with ICH Q9(R1)) |
| Data Integrity | Reinforced in Chapter 4 | Further aligned with MHRA & FDA expectations, including audit trails, access controls |
| Product Quality Review (PQR) | Required annually | Enhanced expectations for data trending and CAPA linkage |
| Supplier Qualification | Strengthened under PE009-16 | Further detailed in Annex 8 with risk-based supplier management strategies |
| Pharmaceutical Quality System (PQS) | Defined in Chapter 1 | Now demands continuous improvement and alignment with ICH Q10 |
| Computerised Systems | Addressed in Annex 11 | Harmonized expectations on cloud-based systems, backups, and electronic batch records |
Is PIC/S PE009-18 Mandatory in Australia?
Not yet. The TGA currently enforces PE009-16, and there has been no formal announcement (as of May 2025) of adoption of version 18.
However, forward-thinking manufacturers should start preparing for the inevitable. With many global regulators (e.g. Swissmedic, HPRA, and TFDA) already referring to PE009-17 or 18, Australian manufacturers may need to adopt newer standards in the near future.
Action Plan: Future-Proof Your Compliance
- Monitor TGA Updates: Stay informed on regulatory notices about adopting PE009-17 or PE009-18.
- Review Annex 1: The revised Annex 1 under version 18 brings major changes in sterile production expectations, such as CCS, visual inspection, and cleanroom qualification.
- Strengthen Data Integrity Practices: Align internal procedures with global expectations.
- Conduct a Forward-Looking Gap Analysis: Compare your systems with PE009-18 now to reduce surprises later.
- Upskill Your QA & Production Teams: Prepare through training sessions and internal audits based on PE009-18.