November 20, 2013
On-line Qualified Person (QP) training has arrived. Visit the Qualified Person training section of our website for further information.
May 13, 2013
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. Read more
March 13, 2013
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. Read more
January 31, 2013
Just a reminder that the new EU GMP Chapter 1 on Pharmaceutical Quality Systems and Chapter 7 on Outsourced Acticities come into operation today (31st January 2013). To read my posts on these from last year and to see in actual text click on the links.
If you need any training support for auditing suppliers and pharmaceutical quality systems then visit our web-site for details of our IRCA registered Pharmaceutical Quality Management Systems Auditor/ Lead Auditor training course.
November 30, 2012
If you perform supplier audits then there are a few things that you should consider. Firstly, ensure you received good training in how to audit. This will make for a better audit and will help to ensure you represent your company professionally. Secondly, try and shadow an existing auditor for a few audits first in order to get a feel for the audit process. As your experience grows then you should get more confident. Eventually though you may end up with a new challenge for all new auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language! How should this be tackled? Read more