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Posts tagged ‘engineer’

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

Duties of key personnel in GMP – Part 3 (Engineering)

April 17, 2012

Dominic Parry

From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP.  In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality.  The role of the Engineering Manager is therefore critical.  In a number of engineering related GMP courses that I have presented in the past we have looked at what the delegates think the Head of Engineering’s role should be, bearing in mind the role is not defined in EU GMP.  Some of the roles already assigned in GMP to the Head of Production can be delegated to them, with additional roles added as well.  Their findings are below: Read more

Calibration

February 20, 2012

Dominic Parry

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration.  GMP requires the calibration of such devices with similar requirements in both EU and USA GMP, as can be seen below: Read more

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