by Dominic Parry | Jan 12, 2023
Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit. This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have...
by Dominic Parry | Oct 30, 2022
Problems happen in work and in life. Problems also happen within any quality system. GMP requires problems to be dealt with correctly: “any deviation … should be avoided as far as possible. If a deviation occurs, it should be approved in writing … (EU GMP...
by Dominic Parry | Oct 16, 2022
All manufacturing sites have a CAPA system, usually a mechanism to deal with things that have gone wrong. Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA...
by Dominic Parry | Jun 13, 2016
In the manufacture of any form of product it is inevitable that, from time to time, things will not go to plan. Problems and deviations from normal practice are a fact of life, and in GMP this is permitted, as long as they are controlled and dealt with correctly....
by Dominic Parry | Jun 9, 2015
Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes. The EU GMP Chapter 8 OLD and EU GMP Chapter 8 NEW versions of the chapter can be found by clicking on...