Skip to main content Skip to search Skip to main navigation
News: EMA

EMA: Work Plan for the Quality Innovation Group

The EMA has published the three-year rolling work plan for the Quality Innovation Group (QIG) for the period 2025-2027. QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines.

The QIG helps to advance international harmonisation through support to relevant ICH guidelines, and to consolidate learnings/support knowledge management for strategic topic areas.

To the activities ongoing/to be finalised in 2025/2026 belong:

EU Guidance documents, New, QIG lead:

  • QIG Preliminary Considerations on Pharmaceutical Process Models

EU Guidance documents, New, QIG specialised input:

  • Questions and Answers on 3D printing
  • Questions and Answers on Decentralised Manufacturing
  • EU GMP Annex 11 on Computerised Systems

Source:

EMA: 3-year rolling work plan for the Quality Innovation Group (QIG)

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

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. 
Read more
Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers

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).
Read more
News: Europe

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

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.

Read more
Question of the Week | GMP-Verlag

What are the General Requirements for Standard Documents?

Here's the answer:
Read more
News: Europe

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.
Read more
Previous
Next