How can we help?
We can provide a complete solution for your GDP needs. From identifying a suitable site, implementing GDP compliant warehouse, writing documents, in particular SOPs, training staff, applying on your behalf to the MRHA and finally helping with the inspection process.
Wholesale Distribution Authorisation
(In line with legislation from 2013, Wholesale Dealer’s Licences became Wholesale Distribution Authorisations, in order to standardise the Authorisations across Europe).
Regulated in the UK by the Medicines and Healthcare Regulatory Authority (the MHRA), storage and distribution of medicines is understandably and reassuringly very stringent.
We have over 25 years’ experience of working with the MHRA, and we can help you to achieve and maintain your WDA.
With the right advice and guidance, compliance with GDP for medicinal products is very achievable (all of our clients have had successful first inspections, and received their Licence accordingly).
We can help you to apply for your WDA and to implement all the requirements or to maintain your existing WDA (see the below guide).
Process for achieving your WDA
A key requirement of the WDA is a suitably qualified and experienced Responsible Person.
We can provide a Responsible Person, registered with the MHRA, who will help you to fulfill all of the requirements of your new WDA, and work with you to ensure that you maintain compliance.
The Responsible Person is responsible for ensuring the safety of the medicinal products throughout storage and distribution, and is your key contact.
In the new GDP guidelines, the 12 listed duties of the Responsible Person are as follows:
1. Ensuring that a quality management system is implemented and maintained;
2. Focusing on the management of authorised activities and the accuracy and quality of records;
3. Ensuring that initial and continuous training programmes are implemented and maintained;
4. Coordinating and promptly performing any recall operations for medicinal products;
5. Ensuring that relevant customer complaints are dealt with effectively;
6. Ensuring that suppliers and customers are approved;
7. Approving any subcontracted activities which may impact on GDP;
8. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
9. Keeping appropriate records of any delegated duties;
10. Deciding on the final disposition of returned, rejected, recalled or falsified products;
11. Approving any returns to saleable stock;
12. Ensuring that any additional requirements imposed on certain products by national law are adhered to.
The Role of the Responsible Person Training Course.
An intensive, practical, one day training course offered by PMN Consulting covering the role of the RP, and all of the Good Distribution Practice Guidelines, as interpreted in the Green Guide 2017, and in the Gold Standard. The Gold Standard has been written by Cogent and approved by the MHRA, and the expectation is that all RPs and deputy RPs will have been appropriately trained.
Quality Management Systems
Deviation Handling, CAPA, Risk Management, Change Control
There is now a requirement that a Risk Management System with all relating areas such as deviations, CAPAs and Change Control be fully documented; the level of formality and effort in the documentation should be linked to the level of risk to patient safety. We can assist you in implementing and maintaining a Risk Management System as well as documentation so as to ensure you become and remain compliant.
Falsified and counterfeit medicines are a huge and growing, global issue. Although new controls are minimising the number of incidents of fake or counterfeit medicines here, the UK continues to be an attractive and lucrative market for criminal activity relating to high value medicines. The size and complexity of supply chains impacts upon the ability to effectively control medicines to ensure that they are genuine.
Legislation introduced in 2013 aims to prevent falsified medicines entering the legal supply chain, and it significantly increases the requirement for wholesale distributors to manage and control their supply chains, and to ensure that medicinal products are only purchased from licensed suppliers and sold to customers legally entitled to purchase them.
Product Recall & Emergency Recall
The ability to quickly and effectively recall medicinal product is a vital requirement of your WDA.
An annual mock recall is also a requirement of your WDA, and this needs to be documented. PMN Consulting can help.
We have over 25 years of managing product recalls and preparing mock recalls – from low key labelling issues through to major emergency recalls to the public. We can help you to develop your system and provide guidance in the event of an actual recall.
A good product recall plan is like a smoke detector – you hope you will never need it, but you are very glad it’s in place if you do!
2 January 2013
EU Falsified Medicines Directive (2011/62/EU) implemented
Click to view Legislation
5 November 2013
New GDP guidelines for medicinal products take effect – these guidelines provide the basis for implementing practices and systems for wholesale distribution (2013/C 343/01)
Click to view Legislation
Click to view Legislation
©2019 PMN Consulting Ltd. All rights reserved.