Responsible Person Named on Wholesale Dealers Licence
Paul Graham Pharma Consulting Ltd can offer experienced and qualified Responsible Persons to be named on your Wholesaler Dealers Licence.
The storage and distribution of pharmaceutical products is receiving increased attention by regulatory authorities and rightly so with the threat posed by counterfeit products and the demands for the use of cold chain storage and shipment being increasingly required for new medicinal products.
The role of the RP is becoming increasingly important as evidenced by the proposal for the training and assessment and certification of RPs in the UK.
Paul is an active RP for 2 companies and has helped to put together Quality Management Systems in compliance with Good Distribution Practice as evidenced by successful MHRA inspections.
PGPC recently assisted 2 of our clients to achieve good regulatory outcomes for their businesses.
One involved PGPC helping Imaging Equipment Ltd (IEL) to vary their Wholesale Dealers Licence to include storage and distribution activities. This involved
- upgrading the quality system to include cold chain storage,
- advice on the purchase of pharmacy refrigerators,
- qualification of the refrigerators and
- hosting the regulatory inspection.
Speaking about the change to the licence, Mr Nick Stevens, Managing Director of IEL stated “We have been delighted with both PGPC’s extensive regulatory knowledge and the high level of professionalism with which this knowledge is applied. This has resulted in a successful variation to our licence but has in addition added something significant to our company’s profile and image, with very positive comments from our MHRA inspector about the professionalism of our own work. Paul has also provided excellent leadership to the IEL team, providing excellent staff training and project management as required.”
View the other success story on the Quality and Regulatory Control Page here http://www.paulgraham-consulting.com/services/quality-and-regulatory-consultation/