FAQs regarding changes to PIC/S GMP Guides Part I & II and PIC/S Annexes (PIC/S Version 17)

This article answers FAQs about PIC/S GMP Guides and PIC/S Versions, such as the effective date of PIC/S Version 17 (and preceding versions PIC/S Versions 15 & 16).

  • What updates to the PIC/S GMP Guides & Annexes will you need to comply with to meet the latest regulatory compliance requirements?
  • And what manufacturing changes should you implement before your next GMP audit or site inspection?

PIC/S GMP Guides & Annexes V17 (PE 009-17)

What’s the current PIC/S Guide?
The current PIC/S Guide is PE 009-17 (PIC/S Version 17), which went into effect on 25 August 2023. However, some regulators do no adopt the latest version until manufacturers have had adequate time to implement the updated GMP guidelines.

While “PIC/S Version 17” (PE 009-17) is the latest version, which PIC/S version your Regulatory Authority (or Authorities) refer to during GMP compliance audits will depend on your distribution region/s (and/or product lines). This can vary across regions.*

Regulatory Landscape

A majority of Regulatory Authorities across the globe have now adopted these updated PIC/S Guidelines (e.g., changes to Annex 1 GMP requirements for the manufacture of sterile medicines). Note: PIC/S Annex 1 updates were first published as a separate document in September 2022; and have now been incorporated into PIC/S PE 009-17 (PIC/S Version 17).

*Not all Regulatory Authorities have adopted the latest PIC/S guidance in Version 17, however, including the Australian TGA, which permits a transition period before adopting newer PIC/S guidance.

Which PIC/S version does the TGA refer to?

The Australian TGA adopted PIC/S Annex 15 (PE009-15) on 25 August 2022 (PIC/S Version 15 is dated the 1st of May 2021). Read more on the TGA website or continue reading for further information on key updates in the PIC/S Guide.

changes to PIC/S GMP guide PICS Version16

History of Changes from PIC/S Version 15 to PIC/S Version 16 (differences) to PIC/S Version 17

  • PIC/S GMP Guide Version 15 (PE 009-15/V15) was published on 1 May 2021.
  • It was replaced by PIC/S GMP Guide Version 16 (PE 009-16/V16) on 1 February 2022.
  • PIC/S Version 17 replaced PIC/S Version 16 (effective 25 August 2023) for many jurisdictions, but not all.

The major differences in the latest PIC/S GMP guidelines (PE 009-17), compared to previous versions (Versions 15 and 16) are related to the three Annexes as overviewed below.

PIC/S Version 17 – updates to Annex 1 now included (they were first published separately)

  • PIC/S Annex 1 – Manufacture of Sterile Medicines; updates were originally published in September 2022 when Annex 16 was still in force; and have now been incorporated into PE 009-17/PIC/S Annexes

PIC/S Version 16 – update to Annex 13 and inclusion of Annex 16 for 1st time

  • PIC/S Annex 13 โ€“ Manufacture of Investigational Medicines (modified in PE 009-16)
    • Updated to align with [new] Regulation No. 536/2014 on Clinical Trials
  • PIC/S Annex 16 for Certification & Batch Release by the Authorised Person (AP)
    • Newly added when PIC/S Guide PE 009-16 (Version 16) went into effect in early 2022
    • Note: Annex 16 generally aligns with European Union (EU) GMP regulations relating to Qualified Persons (QP) and EU batch release processes

PIC/S Version 15 – updated with divisions of Annex 2 into Annes 2A (ATMPs) and Annex 2B (Biologicals); and other changes.

Read more about these changes to PIC/S Guidance at PharmOut.net.

Recommendation for industry: Keep abreast of other industry updates by bookmarking PharmOut’s best-practice pharmaceutical industry blogs and GMP news (updates).

Review the Annex 16 Batch Release Training Presentation.

You can also browse our other Certificate Courses for GMP education topics, including the updated Annex 13 – Manufacture of Investigational Medicinal Products.

PICS GMP changes PIC/S GMP GUIDE Version 16 vs Version 15

What you need to know about complying with the PIC/S GMP Guidelines in Version 17

Personnel, manufacturers, and their suppliers are expected to comply with updates to GMP requirements as of the time these new GMP requirements are published and/or become ‘in force’ within that jurisdiction.

New GMP regulations can intensify existing pressures on manufacturing resources, especially for smaller or mid-sized companies; e.g. talent hours (personnel skills, labour hours), data governance (data integrity), and clinical evidence requirements (testing, data collection/analysis and safety reports โ€“ before and after release to market).

Transitional periods for GMP compliance with new guidelines

There may be transitional periods for compliance with updated PIC/S GMP Guides/Annexes, which can vary per jurisdiction. Refer to guidance from the Regulatory Authorities in the jurisdiction(s) in which you are a Marketing Authorisation Holder (MAH) or Manufacturing & Import Authorisation Holder (MIAH) to review which PIC/S version is being referenced during site inspections for GMP compliance (GMP audits).

Regional example: Therapeutic Goods Administration (TGA) GMP expectations

The TGA (Australia) refers to PIC/S Version 15*, and expects GMP compliance with PIC/S PE 009-15 guidelines, as of 1 July 2022.

  • Prior to 1 July 2022, the Australian TGA were referencing PIC/S Version 14 (PE 009-14), which they adopted in September 2020.
  • PIC/S Version 14 (PIC/s V14) represented significant changes to PE 009-13 (V13) in terms of new V14 requirements for Premises and Equipment (Chapter 3); Production (Chapter 5); Complaints & Product Recalls (Chapter 8); and Real Time Release Testing and Parametric Release (Annex 17).

*Exceptions to updated PIC/S guidance in Australia include Annexes 4 & 5 (Veterinary Medicines) and Annex 14 (Blood & Plasma), which were not adopted by Australia, because other regulations/guidelines apply to those specific product types.

Who must comply with the latest PIC/S Guidelines being referenced by Competent Authorities/Regulatory Authorities and GMP Inspectors/Auditors?

PIC/S GMP guidelines apply to individuals, companies, personnel, contractors, active pharmaceutical ingredient (API) manufacturers, importers, distributors and other supply chain operators involved in pharmaceutical manufacturing, medical device manufacturing, & veterinary medicines manufacturing.

You must also meet all conditions of your Marketing Authorisation/Import Authorisation, and consult any region-specific & product-specific guidance to understand your GMP responsibilities and other legal requirements for product quality, safety, and efficacy/performance.

FAQ#1: What is the latest or current version of the PIC/S GMP Guide?

Answer: The latest version of PIC/S GMP Guides & Annexes = PIC/S Version 17 – PE 009-17. PIC/S Version 17 went into effect on 25 August 2022.

To download the latest PIC/S GMP Guide (Version 17) – PE 009-17, Click on the links below:

PICS Version 16 updates to Annex 13 16

FAQ#2: When does PIC/S Version (PE 009-17) go into effect according to most Regulatory Authorities?

Answer: The PIC/S Guide (Version 17) is dated 25 August 2023, with some Regulatory Authorities immediately adopting updates and changes to the PIC/S GMP Guide & Annexes.

In other jurisdictions, such as Australia, longer transition periods may apply. This means adapting to updates/changes to GMP Guidance can be done over time (but procrastination in the face of a looming ‘in force’ date is definitely not recommended).

Note: The Australian TGA only recently adopted PIC/S Version 15 (PE 009-15) on 1 July 2022.

It is not yet clear when Australia will adopt PIC/S PE 009-16 or PE 009-17; e.g., when the TGA will refer to PIC/S Version 16 or Version 17 instead of PIC/S Version 15 for GMP compliance decisions/GMP audits and inspections. TGA = Therapeutic Goods Administration.

FAQ#3: What were the major changes between PIC/S Version 15 and PIC/S Version 16?

As already noted, the major differences in the PIC/S GMP Guide (PE 009-16/V16), compared to the previous PIC/S GMP Guide (PE 009-15/V15) relating to the following two Annexes:

However, the new European Union Annex 1 (EU Annex 1) published on 25 August 2022, goes into force on 25 August 2023 (1 year after its publication in Eudralex Volume 4).

PIC/S Version 17 has the same ‘in effect’ date as the EU’s Annex 1 (25 August 2023).

News about EU Annex 1 guidance updates for the manufacture of sterile products/medicines

With the European Union’s updated Annex 1 (EU Annex 1) for sterile medicinal products in force in August 2023, the revised PIC/S GMP Guide (Version 17) was published and is also now in effect in many countries. It includes the regulatory guidance updates to Annex 1.

Here’s what you need to know about the updated EU Annex 1 publication (August 2022) going into force in August 2023:

PICS-version-16-annex13-annex16update

Learn from the experts: Attend Annex 1 training presentations/course sessions with the GMP compliance experts at PharmOut – click here for schedules or contact PharmOut for facilitated training of large groups of personnel.

You can also download the EU Annex 1 guidelines (PDF version) here.  

For assistance updating your sterile manufacturing processes and PQS documentation, validation and data storage systems, and/or pharmaceutical technical writing (SOP updates, new procedures, updated Work Instructions, design specifications, etc), click here for PharmOut’s highly-respected, best-practice GMP consultants.

PQS template packages are also available.

Review the Annex 16 Batch Release Training Presentation.

Browse other Certificate Courses for GMP education topics and best-practice manufacturing, including the updated Annex 13 – Manufacture of Investigational Medicinal Products.

Last updated on December 5th, 2023 at 09:07 am

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