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Whether you take GDP training is no longer your choice. The updated European Guidance requires RPs to take regular training, and we recommend annual refresher training as a minimum. Where there have been no Regulatory updates, consider something more specialised like Quality Risk Management Training or Validation Training. Click our services page to see what offerings we have.
GDP training can vary significantly in cost. Common market rates are from £500 + VAT to £875 + VAT per person, per day. Paradigm will work with you to build a bespoke GDP training session or try to merge you with some of your peers to significantly reduce cost and share experiences. Contact us.
Looking to get your wholesale dealer licence/wholesale distribution authorisation? Unsure quite what to do? We can help, from application, to inspection, and through to retention and re-inspection. Ask us about our application service and our Deputy Contract RP service. More cost effective than a full contract RP post for those who already have a good working knowledge and are prepared to learn to manage their own business. Especially helpful for pharmacy wholesalers as you have constant access to a GDP Professional, yet continue to learn and pay less for the support. Not recommended for those who do not take GDP seriously, or are not interested in learning more.
In wholesale terms GDP means “Good Distribution Practice” which regulates the movement of medicines or medical products from the manufacturer to wholesaler.
An RP is, in GDP terminology, a Responsible Person. The RP has oversight and responsibility for Good Distribution Practice within a wholesale operation, as well any interactions with third parties that the licence holder deals with. The RP may delegate duties, but not responsibilities.
A Contract RP is a Responsible Person who is recruited for the role, and generally not based onsite full-time. The Contract RP has oversight and responsibility for Good Distribution Practice within the wholesale operation, as well any interactions or approvals of third parties that the licence holder deals with. Need a Contract RP for your site? Contact us for an informal discussion.
We aim to provide great value, not “cheap.” For those who have a fundamental understanding of GDP, but want some external support for audits and QMS review, Paradigm Shift Consulting offers Contract Deputy RPs, or regulatory consultancy. We can assist with your questions and back you up as RP/licence holder. Due to the reduced risk and requirement to spend time on your site the costs can be far lower that it would if one of our team were named on your licence. This is, however, dependent on your model and your needs. Contact us for more information.
The MHRA are the Medicines and Healthcare Products Regulatory Agency, and are responsible for regulating both medicines and medical devices in the UK. They achieve this by making sure they work and are acceptably safe. Read more about them here; http://www.mhra.gov.uk/Aboutus/Whoweare/
Yes! Whether you need a pre-inspection review of your site, a third party site audit, or a full GDP audit against 2013/C 343/01 we can help. We also audit 3PLs and suppliers. Contact us for more information.
A QMS is a Quality Management System. A QMS in GDP terms is the combination of your people, process, facilities, equipment and ICT, not just a set of SOPs. The MHRA expect a full GDP compliant QMS to be in place
SOPs are Standard Operating Procedures. These are your documents which list the processes you carry out in your wholesale operation. SOPs must be paginated, version controlled and in language easily understood by the personnel. Do you have good quality, clear and accurate SOPs? Need an SOP review or a full set of GDP compliant SOPs? Contact us.
The short answer is no, but it’s not that simple.
There are many companies who have free online GDP training, which can be little more than a copy of the EU Guidance 2013/C 343/01. The Competent Authorities are not fond of online training. How do you know who completed the test? There is no trainer-trainee interaction or Q and A. Have GDP training needs? Contact us for a no obligation discussion.