TGA Guidance: GMP Update for Medicinal Products in Australia: Transitioning to PIC/S Guide PE009-17

Sharan Murugan
Aug 28
2 min read

Good Manufacturing Practice (GMP) serves as the backbone of pharmaceutical quality assurance. It ensures that medicinal products are consistently produced and controlled according to quality standards that safeguard patient safety. In Australia, GMP requirements are aligned with international best practices through the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

PIC/S (Pharmaceutical Inspection Co-operation Scheme): An international organisation harmonising GMP standards across regulators.

CCS (Contamination Control Strategy): A documented plan integrating preventive and monitoring controls to ensure product sterility.
APS (Aseptic Process Simulation): A media-fill test mimicking aseptic operations to demonstrate sterility assurance.

On 1 September 2025, the Therapeutic Goods Administration (TGA) will adopt the PIC/S Guide to GMP PE009-17, replacing the earlier PE009-16 (February 2022). This change primarily updates Annex 1 – Manufacture of Sterile Medicinal Products, reflecting global developments in sterile manufacturing controls.

The move from PE009-16 to PE009-17 strengthens the control framework for sterile medicines and Active Pharmaceutical Ingredients (APIs). Most updates clarify existing expectations, but some require operational changes.

The new requirements focus on:

Enhanced contamination control
Use of advanced technologies (e.g., isolators, robotics, continuous monitoring)
Stricter microbiological standards
Stronger documentation and periodic review mechanisms

These align with international standards like ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), ensuring Australia remains harmonised with global regulators.

Key Updates in Annex 1

1. Facility and Equipment Design

Sterile product manufacturing must minimise microbial, particulate, and endotoxin contamination. Facilities should integrate modern technologies such as isolators, Restricted Access Barrier Systems (RABS), robotics, and rapid testing systems.

Existing compliant facilities may continue with legacy systems if supported by science-based justification.
New facilities or refurbishments should adopt contemporary contamination-control technologies.

2. Contamination Control Strategy (CCS)

A CCS must be developed to map critical control points, evaluate risks, and integrate preventive measures across:

Facility and process design
Equipment and utilities
Raw materials, containers, and closures
Cleaning, disinfection, and sterilisation validation
Outsourced services and vendor approval

The CCS should be a living document, periodically reviewed for effectiveness, and embedded into management reviews.

Cleanroom Controls

Airlocks: Separation of personnel and material airlocks is encouraged. Where this is not possible, time-based separation should be enforced.
Cleanroom Qualification: New microbiological limits now define Grade A cleanrooms as requiring “no growth”, moving away from <1 CFU. All cleanroom sampling methods must be scientifically justified.
Personnel Gowning : Introduction of facility socks as a contamination control measure. Outdoor socks are prohibited in higher-grade areas.
Airflow Studies: Airflow visualisation should form part of operator training to prevent disruption of unidirectional airflow in critical zones.

4. Aseptic Practices

Observation of Operations: Aseptic processing must be routinely observed by experts to detect deviations.
Aseptic Process Simulation (APS):
- APS runs must simulate all critical steps.
- Zero growth is the acceptance standard; any contamination results in a failed APS.
- Failed APS requires full investigation, corrective actions, and at least three successful repeat runs before resuming production.
- APS cannot be aborted without documented justification.
Microbial Identification: Any microorganism detected in Grade A and B cleanrooms must be identified to species level, and risk assessed for product impact.