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All wholesale distributors have to appoint a Responsible Person (RP) for Good Distribution Practice(GDP). The RP is responsible for safeguarding product users (patients) against potential hazards arising from poor distribution practices. The European GDP Guideline of 5 November 2013 (EU 2013/C 343/01)

22 12, 2015

Bona Fides Supplier Customer Checks

By |2016-12-26T16:21:42+00:00December 22nd, 2015|Bona Fides Checks, Good Distribution Guidelines, Quality Management System, Quality Risk Management, Responsible Person (RP), Standard Operating Procedures|0 Comments

Bona Fides … What? Bona fides is a Latin phrase meaning ‘good faith’ and is the opposite of mala-fide (‘in bad faith’) The Oxford Dictionary defines it clearly as “evidence that somebody is who they say that they are; evidence that somebody/something is honest” Although not explicitly mentioned in the EU 2013/C 343/01 GDP Guidelines, [...]

29 11, 2015

Contract Responsible Person RP

By |2016-12-26T16:21:42+00:00November 29th, 2015|Contract RP's, Good Distribution Guidelines, Personnel, Responsible Person (RP), Training|0 Comments

Contract Responsible Person RP One of the provisos of obtaining a Wholesale Distribution Licence / Authorisation is the nomination of a Responsible Person. Contract Responsible Person RP If you have the required experience and knowledge you can take on the role of Responsible Person and be named on your own application. You will of course [...]

29 11, 2015

Wholesale Distributor Licence / Authorisation

By |2015-11-29T14:58:45+00:00November 29th, 2015|Falsified Medicines, Good Distribution Guidelines, Quality Management System, Responsible Person (RP), Training|0 Comments

Wholesale Distributor Licence / Authorisation So, you now have a business plan and are ready to take the world over with your new venture. The cash flow projections look good and you are ready to activate your network and announce the news that you will soon be trading after applying for the all-important Wholesale Distributor Licence / [...]

16 10, 2015

Virtual Distribution – Contracting Services

By |2016-12-26T16:21:42+00:00October 16th, 2015|Contract Admin Sites, Contract RP's, Contract Warehousing, Responsible Person (RP), Virtual Distribution|0 Comments

Contracting  Services is now becoming a popular mechanism for new entrants. The new Good Practice Guidelines EU 2013/C  43/01 are a step in the right direction to ensure product quality and ultimately patients are safeguarded through improvement of standards across the supply chain. However the requirements have significantly increased the cost to the industry, making it [...]

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