Skip to main content Skip to search Skip to main navigation

Which categories of documents do the EU GMP Guidelines identify?

The EU GMP Guidelines distinguish between two basic document types: instructions (directions or requirements) and records/reports.

[GMP Compliance Adviser, Chapter 15.B]

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