Guideline Knowledge Base

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/regulatory-and-procedural-guideline.xml).

The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, for example, via third party service providers. Systems to support these ways of working can range from manual processes with paper records to the use of fully computerised systems. The main purpose of the regulatory requirements remains the same, i.e. having confidence in the quality and the integrity of the data generated (to ensure patient safety and quality of products) and being able to reconstruct activities.

This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the GMP Guide”) gives guidance on the taking and holding of reference samples of starting materials, packaging materials or finished products and retention samples of finished products.

This Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal products for human or veterinary use holding a marketing authorisation (MA) or made for export. The principles of this guidance also apply to investigational medicinal products (IMP) for human use, subject to any difference in the legal provisions and more specific guidance published by the European Commission.