Skip to main content Skip to search Skip to main navigation

How should change management be documented?

The documentation of change management is not limited to the documentation of individual cases. Change management must be anchored in the quality policy and the validation master plan and described in standard operating procedures. In addition, all raw and summary data used in connection with a change must be fully recorded and stored.

[GMP Compliance Adviser, 1.D]


 

Would you like to discover more?

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:

EMA: New Q&A on Product Lifecycle Management (PLCM)

EMA: New Q&A on Product Lifecycle Management (PLCM)

The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.
Read more
EMA: New Q&A for Co-Processed Excipients

EMA: New Q&A for Co-Processed Excipients

The EMA has published new Questions & Answers on co-processed excipients (CoPEs) used in solid oral dosage forms, introducing a harmonised, risk-based regulatory approach applicable to human and veterinary medicines.

Read more
What is the Data Lifecycle?

What is the Data Lifecycle?

Here's the answer:
Read more
Previous
Next