PIC/S Guide Update and Annex 16 Adoption: Navigating Australia’s Pharmaceutical Landscape

Australia is set to make a significant step in enhancing the safety and efficacy of medicinal products, active pharmaceutical ingredients (APIs), and sunscreens with a planned update to its manufacturing principles. As of 3rd June 2024, the country will transition to PIC/S Guide to GMP – 1 February 2022, PE009-16, with exclusions from Annexes 4, 5, and 14, which are not adopted by Australia.


  • Annex 4: Manufacture of veterinary medicinal products other than immunologicals [Not adopted by the TGA]
  • Annex 5: Manufacture of immunological veterinary medical products [Not adopted by the TGA]
  • Annex 14: Manufacture of products derived from human blood or human plasma [Not adopted by the TGA]

PIC/S Guide – Comprehensive Structure

PIC/S is an international organization that provides a framework for the cooperation of pharmaceutical inspection authorities. The primary goal of PIC/S is to promote the harmonization of Good Manufacturing Practice (GMP) standards and quality systems in the pharmaceutical industry.

The PIC/S Guide to GMP – 1 February 2022, PE009-16 is structured into two parts with 20 annexes, offering detailed insights into various aspects of manufacturing processes:

  1. Part I: Covers GMP principles for the manufacture of medicinal products.
  2. Part II: Addresses GMP for active substances used as starting materials.
  3. Annexes: Provide detailed information on specific areas of activity, including the manufacture of sterile medicinal products, advanced therapy medicinal products, and more.

Understanding the Key Changes in the PIC/S Guide to GMP: Annex 13 and Annex 16

The primary changes in version 16 of the PIC/S Guide revolve around Annex 13 and Annex 16.

  • Annex 13: This amendment focuses on providing essential information and requirements to address specific issues related to the manufacture of investigational medicinal products and aligns with Regulation No. 536/2014 on Clinical Trials.
  • Annex 16: Australia is set to adopt Annex 16, outlining crucial information and requirements concerning the certification by an Authorized Person and the batch release of medicinal products, aligning with European Union (EU) regulations on Qualified Persons (QP) and batch release processes.

In our previous blog posts, which can be viewed below we provided a detailed review of the changes:
PIC/S PE 009-16 update, Part 1 – changes to Annex 13,
PIC/S PE 009-16 update, part 2: New Annex 16 vs Release for Supply

Implementation and Adoption Timeline of PIC/S Guide to GMP

The adoption of the updated guide is scheduled to commence on 3rd June 2024. GMP inspectors will employ the new guide during inspections, and compliance with its requirements is expected. The Therapeutic Goods Administration (TGA) has conducted multiple industry consultations and will continue collaborating with the industry to develop further interpretative guidance where necessary.

Manufacturers’ Call to Action: Review and Adapt

Manufacturers are strongly encouraged to proactively review the PIC/S Guide to GMP – 1 February 2022, PE009-16 to ensure a smooth transition and guarantee that their manufacturing operations align with the updated requirements. Being well-versed in the specifics of the new guide is pivotal to maintaining compliance and upholding the highest standards in the production of medicines, active pharmaceutical ingredients, and sunscreens.

How Manufacturers Can Prepare

  1. Initiate a Comprehensive Review: Manufacturers should begin a thorough review of the PIC/S Guide to GMP – 01 Feb 2022, PE009-16, understanding both Part I and Part II, along with the annexes, to grasp the intricacies of the new manufacturing principles.
  2. Update Standard Operating Procedures (SOPs): Align existing SOPs with the revised GMP principles. Ensure all procedures, protocols, and documentation are in harmony with the updated requirements outlined in the new guide.
  3. Employee Training and Awareness Programs: Conduct relevant training sessions for all staff involved in the manufacturing process, including personnel in production, quality control, and other relevant departments. Employees must be well-versed in the changes introduced by Annex 16 to ensure compliance.
  4. Engage in Communication with Regulatory Authorities: Establish open lines of communication with the Therapeutic Goods Administration (TGA) and other relevant regulatory bodies. Seek clarification on any ambiguities and stay informed about interpretative guidance as it becomes available.
  5. Risk Assessment and Mitigation: Perform a comprehensive risk assessment of the manufacturing processes in light of the new GMP guide. Identify potential gaps or areas that may require additional attention and implement measures to mitigate any risks.
  6. Technology and Infrastructure Evaluation: Evaluate existing technology and infrastructure to ensure compatibility with the updated standards. Manufacturers may need to invest in new technologies or upgrade existing systems to meet the revised GMP requirements.
  7. Collaborate with Industry Peers: Participate in industry forums, workshops, and collaborative initiatives. Sharing insights and experiences with peers can provide valuable perspectives on how different organizations are adapting to the changes.
  8. Audit Preparedness: Conduct internal audits to assess the preparedness of manufacturing processes for compliance with Annex 16. This includes a thorough examination of certification processes and batch release procedures.
  9. Documentation and Record-Keeping: Enhance documentation practices to ensure accurate record-keeping in accordance with the new GMP guide. Robust documentation is crucial for demonstrating compliance during inspections.
  10. Seek Professional Consultation if Needed: Manufacturers encountering challenges or uncertainties during the transition can seek professional consultation services. Engaging with experts in regulatory affairs can provide valuable guidance in adapting to the revised manufacturing principles.

As Australia gears up for this pivotal shift in manufacturing principles, the focus remains on ensuring the highest quality and safety standards in the production of medicinal products, active pharmaceutical ingredients, and sunscreens. Manufacturers play a crucial role in this transition by staying informed and adapting their processes accordingly, contributing to a more robust and reliable healthcare ecosystem.

Other blog posts:

Part 1: Changes to Annex 13
Part 2: New Annex 16 vs Release For Supply
Changes To PIC/S GMP

Available training courses:

Annex 13 – Manufacture of Investigational Medicinal Products
Annex 16 – Authorized Person and Batch Release

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