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March 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|

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 [...]

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)|

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 [...]

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)|

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 [...]

January 2016

Good Distribution Practice Training Coupon

By |2016-12-26T16:21:42+00:00January 4th, 2016|Good Distribution Guidelines, Personnel, Training|

Good Distribution Practice Training Coupon March 2016 Discount Offer  Treat yourself to a £100 discount using our Good Distribution Practice Training Coupon. Pharma Experts updated intensive courses are interactive and cover: Role of the MHRA GDP and Patient Safety Principles of Quality Management Quality Risk Management Documentation Control Managing Change The Role of the RP Operation including [...]

December 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|

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, [...]

THMP Traditional Herbal Medicinal Products

By |2016-12-26T16:21:42+00:00December 3rd, 2015|Good Distribution Guidelines, THMP, Training|

Traditional Herbal Medicinal Products THMP Pharma Experts has received a number of calls from potential clients based in the UK and India with an interest in the process involved in the marketing and distribution of Traditional Herbal Medicinal Products THMP including Ayurvedic medicines. The European Commission Report Chapter 2a of Directive 2001/83/EC, as amended by [...]

November 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|

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 [...]

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|

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 / [...]

October 2015

Falsified Medicines in the UK

By |2015-11-29T15:20:23+00:00October 16th, 2015|Falsified Medicines, Falsified Medicines Directive, Good Distribution Guidelines|

The term counterfeit medicines refers to medicines which are fraudulent imitations of medicines available on the market. Falsified medicines are fake sub-standard medicines which attempt to pass off as real, bona fide medicines. They may contain ingredients but are of  low quality or in the wrong dosage Falsified medicines are a risk to patient safety [...]

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|

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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