New validation

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

Hi.
I have been told of some new validation legislation coming into force at the end of the year in UK / Europe. Does anyone know what legislation / guidance it is and what types of validation it covers . i understand it may be cleaning validation

Thanks , hookeslaw

2

Hi,

EU GMP Annex 15 - Qualification and Validation and
Annex 16 - Qualified person and Batch release are under revision.

Both, valid version and also draft are available on

You can see there also Part’s I chapters were updated:
Chapter 3 - Premises and equipments
Chapter 5 - Production
Chapter 6 - Quality control
Chapter 8 - Complaints and Products recalls

3

Nice summary on major changes in EU GMP Annex 15 - Qualification and Validation is on European Compliance Academy:

and interesting industry survey on Revision of Annex 15 here: