The first steps...

What on Earth is a QP? According to EU directives 2001/83/EC or Directive 2001/82/EC and EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines annex 16, a suitably qualified person is responsible to ensure that medicinal products manufactured within Europe have been manufactured and checked in compliance with EU GMP and in accordance with the requirements of the marketing authorization. QPs are also responsible for ensuring medicinal products coming from outside of the EU have had all tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation. How do I become a QP? Different member states in the EU have interpreted the requirements 2001/83/EC in different ways. In the UK, typically a QP needs a degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. Additionally a QP needs to have worked for at least two years under a manufacturing authorisation. In order to become a QP in the EU, you must meet the requirements in the QP Study Guide and be a member of the Royal Society of Chemistry, Biology or Pharmacy. The QP study guide can be accessed vial the royal society websites. You also need a QP sponsor to help guide you through the process and to vouch for you on your application form. It is a good idea to perform a gap assessment to determine where you meet the requirements of the study guide and where you need to gain extra knowledge. If you have major gaps in your knowledge and experience (as I most certainly do) don't worry. There are courses out there that you can go on fill in the gaps. The providers include (but are not limited to) University of Brighton (Industrial Pharma Studies), David Begg, Inspired Pharma, RSSL and University College London (QP3) The courses vary a lot. There are pros and cons to each course, so make sure you research which is best for you. Once you have met the requirements of the study guide, you and your sponsor will need to complete an application form. The forms can be accessed from the Royal Society websites. After you have completed your application form, members of the Royal Society's panel will assess the application form and will either send it back for more information or accept the applications and send a viva date. This process takes several months. For the QP viva, you will be asked questions by three QP assessors from he Royal Society's panel. If your viva is successful, you will become a Qualified Person!

Welcome

Hello and welcome to my blog! Thanks for taking a look. The reason for this blog is two fold. One to help those of you thinking of taking the leap an starting the process of becoming a QP to see what the training entails. Two, so that when I come to complete my Application I can remind myself of the experience that I have gained during my training. All the best Laura