Guidance: How to handle temporary Changes in the Quality System

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have updated their questions and answers document on regulatory expectations for medicinal products for human use during the covid-19 pandemic. In the latest revision a new section on "Additional temporary GMP and GDP flexibility" was added.

In this new section, the possibility to "implement temporary changes to certain scheduled quality related tasks" is addressed. These changes in elements of the quality system are possible for the "redirection of resources to focus on supply of crucial medicines". If appropriately justified, these temporary changes "could apply to deferral of certain routine operations such as":

• Maintenance, requalification, revalidation, recalibration,
• Periodic review of PQS documents,
• On sites re-audits of suppliers, and replacement by remote audits,
• Periodic re-trainings,
• Stability testing.

However some pre-requisites need to be considered:

• Changes do not adversely impact quality, efficacy and safety of medicinal products.
• Changes should be managed transparently within the pharmaceutical quality system (PQS) and documented.
• Quality risk management should be employed.
• The Qualified Person (QP) should be made aware of any planned changes.
• Changes cannot be used to facilitate certification of batches affected by non-compliance with registered specifications.