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Posts tagged ‘GMP’

Management Review – what is it for?

September 10, 2012

Dominic Parry

In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place.  Read more

The positioning of the Qualified Person (QP) within the organisation

April 24, 2012

Dominic Parry

In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP).  In this post we look at the organisation of these people within the business.  It is in the spirit of GMP that these roles are taken by people who are permanent employees of the organisation in full-time roles (EU GMP Chapter 2.3), but does that mean you need to employ three different individuals?  Can, for example, you be the Head of QC and also be the Qualified Person?  This article looks into this. Read more

Duties of key personnel in GMP – Part 4 (Human Resources)

April 20, 2012

Dominic Parry

From Parts 1, 2 and 3 of this post we have focused on the duties of the three key personnel named in EU GMP (the Head of Production, QC and the Qualified Person).  We have also highlighted that there is no formal requirement for an Engineering Manager (or Department) AND a Quality Assurance Manager (or Department) in GMP.  Most pharmaceutical manufacturing sites do actually have these people (and departments) and we have looked at the roles and responsibilities commonly performed by these in previous posts.  There is also a final “key personnel” not named in GMP, namely the Human Resources Manager.  Bearing in mind that in the manufacture and testing of medicines it is the employees themselves who have a massive impact on product quality and the quality system then the importance of the individual who looks after employees (usually the HR Manager) cannot be understated. Read more

Do QC labs work to GLP?

March 29, 2012

Dominic Parry

This is a commonly asked question on my training courses which is generally misunderstood.  Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP.  GLP stands for Good Laboratory Practice, and this is the system used to cover the performance of toxicological studies on an animal, done as part of medicinal product development.  Read more

New structure to EU GMP

March 28, 2012

Dominic Parry

The structure of European Union (EU) GMP has been adjusted slightly as can be seen from the EUDRALEX web-site. A new Part 3 has recently been introduced.  For some time now GMP has been split into 2 Parts. Read more

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