Regulatory

GMP regulatory calendar

A deliberately short list. Every entry is a well-established change, linked to the authority that issued it, with the practical consequence stated separately from the official text.

Last reviewed

2026-09-05

Not exhaustive, and not a regulatory alerting service. Confirm current status at the source before acting.

Entries

What changed, and what it may affect

European Commission · Sterile manufacture · contamination controlEffective

EU GMP Annex 1 — Manufacture of Sterile Medicinal Products (revised)

Published: August 2022
Applies: 25 August 2023 (the lyophilisation provision at 8.123 applied from 25 August 2024)

GMP processes potentially affected

Facilities and utilities
Production
Quality management system
Validation
Documentation and records
Training and competence
Quality risk management

GMPConsultant.nl note

The revision reorganised sterile requirements around quality risk management and a documented contamination control strategy. The most common gap is a CCS assembled by cross-referencing existing SOPs rather than written as a site-level strategy with evidence of effectiveness.

Verify at European Commission Read the reference article Analyse potential impact

ICH · Quality risk managementRevised

ICH Q9(R1) — Quality Risk Management (revision)

Published: Reached Step 4 in January 2023
Applies: Adopted by regional regulators on their own timetables

GMP processes potentially affected

Quality management system
Quality risk management
Validation
Supplier and CMO management
Documentation and records

GMPConsultant.nl note

The revision sharpened subjectivity in risk scoring, the appropriate degree of formality in risk management, and how risk-based decision-making should work. If your risk assessments are scored by a group that already knows the desired answer, this is the text that addresses it.

Verify at ICH Read the reference article Analyse potential impact

ICH · Continuous manufacturingEffective

ICH Q13 — Continuous Manufacturing of Drug Substances and Drug Products

Published: Reached Step 4 in November 2022

GMP processes potentially affected

Production
Validation
Quality control and laboratory
Computerised systems
Quality management system

GMPConsultant.nl note

Relevant only to sites operating or considering continuous manufacturing. Where it applies, control strategy and process validation expectations differ materially from batch manufacture.

Verify at ICH Read the reference article Analyse potential impact

ICH · Analytical proceduresEffective

ICH Q2(R2) and Q14 — Analytical Procedure Validation and Development

Published: Reached Step 4 in November 2023

GMP processes potentially affected

Quality control and laboratory
Validation
Documentation and records
Data integrity

GMPConsultant.nl note

Q14 introduces a structured approach to analytical procedure development; Q2(R2) revises validation expectations alongside it. Most relevant to QC laboratories reviewing method lifecycle documentation.

Verify at ICH Read the reference article Analyse potential impact

Limits

What this calendar is not

This calendar is not exhaustive and is not a regulatory alerting service. It lists a small number of well-established changes, each linked to the issuing authority. Dates and status change, and regional adoption of ICH guidance varies — always confirm the current position at the source before acting on it.

Next step

Work out what a change touches

The change impact analyser turns a set of affected GMP areas into a consolidated review checklist: what QA should review, which evidence may need re-examination, and the questions to answer before concluding no impact.

Open the impact analyser Source library