PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

24.06.2021

News

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.

Following the revision of EU Annex 16 Certification by a Qualified Person and Batch Release in 2016, PIC/S decided to transpose Annex 16 in order to harmonise internationally requirements regarding product release.

The PIC/S Committee had internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16. The PIC/S document was written with a view to applicability across the members worldwide. Therefore, it focusses especially on important technical elements of QP release decisions.

The Committee recently agreed to proceed to Step 2 of the PIC/S consultation process. Step 2 of the PIC/S adoption process enables an opportunity for PIC/S Participating Authorities to consult with stakeholders.

This consultation was launched on 15 June 2021 for a period of 3 months. The consultation will focus on national stakeholders of non-EU/EEA Members of PIC/S, considering that EU/EEA Members of PIC/S already apply EU Annex 16.

Source:

PIC/S: News

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers

11.09.2026

News

Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers

Swissmedic has revised its guidance document “GMP compliance by foreign manufacturers”. The new Version 7.0 has been valid since 7 September 2026. In particular, it introduces new provisions for demonstrating the GMP compliance of manufacturers inspected by the US FDA.

Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers

11.09.2026

News

Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers

Swissmedic has revised its Technical Interpretation “Market release and distribution in cooperation with a pre-wholesaler”. The document addresses market release and distribution where a Marketing Authorisation Holder works with a pre-wholesaler (logistics and distribution service provider).

11.09.2026

News

IPEC Updates Two Guides on Pharmaceutical Excipients

The IPEC Federation has updated two key guides on pharmaceutical excipients. The IPEC Composition Guide for Pharmaceutical Excipients (Version 3, 2026) describes an approach for manufacturers to establish excipient composition profiles. The revised version now covers biotechnology- and fermentation-derived excipients, provides further details on component types and physicochemical characterisation, and includes an example composition profile template.

07.09.2026

Question of the Week

What are the General Requirements for Standard Documents?

Here's the answer:

Applying the FDA’s 7-Step Model for AI/ML Validation in GMP Environments: One Year Later

07.09.2026

LOGFILE Feature

Applying the FDA’s 7-Step Model for AI/ML Validation in GMP Environments: One Year Later

Artificial intelligence is becoming increasingly important in GMP-regulated environments, presenting companies with new regulatory challenges. This article summarizes the latest regulatory developments, introduces a validation framework based on the FDA's seven-step model, and outlines initial practical experience with AI/ML validation.

04.09.2026

News

EDQM: Revised Guidance on Sister File Applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised its Guidance on applications for “sister files” (PA/PH/CEP (09) 141). The revision is intended to support consistent application of the procedure and provide greater clarity on the classification and assessment of the corresponding CEP applications.