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Quality Management System for Wholesale Distributors setting out responsibilities, processess and risk management principles in relation to their activities . All critical steps should be clearly defined and systematically reviewed. The European GDP Guideline of 5 November 2013 (EU 2013/C 343/01).

15 03, 2016

Technical Agreements for Outsourced Activities in GDP

By |2016-12-26T16:21:42+00:00March 15th, 2016|Good Distribution Guidelines, Quality Management System, Technical Agreements|0 Comments

Technical Agreements for Outsourced Activities in GDP Chapter 7 of the EU Guidelines 2013/C 343/01 refers to the outsourcing of Good Distribution Practice activities to third party providers: Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity [...]

10 03, 2016

15 Benefits of Quality Systems in GDP (Good Distribution Practice)

By |2016-03-10T13:07:11+00:00March 10th, 2016|Good Distribution Guidelines, Quality Management System, WDA (H)|0 Comments

15 Benefits of Quality Systems in GDP EU GDP Guidelines 2013/C 343/01 introduced the concept of Quality Systems to GDP operations with the overarching aim to maintain product integrity and ultimately the safety of patients. Chapter 1, Quality Management 1.1. Principle Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management [...]

8 03, 2016

Registering as a Wholesale Distributor of Medicines

By |2016-12-26T16:21:42+00:00March 8th, 2016|Good Distribution Guidelines, Quality Management System, WDA (H)|0 Comments

Registering as a Wholesale Distributor of Medicines in the UK with the MHRA  Case Study* A UK based company with an ambition to be a leading exporter of pharmaceuticals to the Latin America approached Pharma Experts for support and advice on how they could acquire a Wholesale Distributors Authorisation (aka WDA (H) or Wholesale Dealers [...]

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

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 / [...]

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