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Posts tagged ‘GMP’

Curriculum Vitaes in Training Records

May 13, 2013

Dominic Parry

I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records.  This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.CV1 Read more

Update to the EU’s Good Distrubution Practice guidelines

March 13, 2013

Dominic Parry

Good Distribution Practice, or GDP, is the standard used to cover the movement and transport of materials.  Historically GDP covered the movement of finished product from the pharmaceutical manufacturing site to the wholesalers and retailers and strictly speaking this is still the case.  However with ever more complicated movements of starting materials, intermediate products and finished products then the principles of GDP can apply throughout the whole supply chain – covering the movement of all materials both to and from a pharmaceutical manufacturing site.GDP Read more

Update to EU GMP Chapter 1 – Pharmaceutical Quality System

October 26, 2012

Dominic Parry

After a longer period of review and many draft versions published the final update to EU GMP Chapter 1 on “Quality Management” comes into operation on 31st January 2013. Here is a summary of the main changes. Read more

Non-conformity – not following a procedure

October 17, 2012

Dominic Parry

A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy.  This is a non-conformity, and should be raised as such.  The problem is – what clause of the standard actually states that you should follow your procedures?  On investigation this is not as easy to find as you might like to think! Read more

Make GMP training more interesting

September 28, 2012

Dominic Parry

At some point every year (or perhaps every 2 years) someone in a pharmaceutical organisation will say “It’s time to think about this year’s GMP training”.  This statement will usually be received with little enthusiasm from those who hear it, but nevertheless a plan will be formed to deliver the training over the next 4 or 5 months or so.  On the day of the training the majority of delegates will arrive with equally low levels of enthusiasm as the annual chore of GMP training begins.  “Right – let’s make a start” the trainer will say, as the delegates think “well let’s get this over and done with” as they listen (whilst trying to stay awake) to the focus area of this year’s training – which is usually what they did so badly wrong last year! Read more

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