Friday, 18 July 2014

Good Distribution Practice for Medicinal Products for human use

The European Commission has issued an updated to questions and answers relating to Good Distribution Practice (GDP).  Q&A has been updated in order to clarify the EU GDP guideline.

There are 25 questions and answers within the document.

For example:

QUESTION: In Chapter 3 – Premises and Equipment, 3.2.(3), is the intent of segregation to avoid ‘cross contamination’ as mentioned in Chapter 5?

Answer: The intent of this provision is to avoid handling errors and accidental swaps of products. This is why electronic segregation is allowed, except for falsified, expired, recalled and rejected products which always have to be segregated physically.

To view the document, go to EU GDP.

Posted by Tim Sandle