Distribution of Medicines – Quality Management Systems
The current guidelines: Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) requires a Quality Management System that describes your processes for the distribution of medicinal products.
A main requirement of gaining a WDA (H) is to have a documented Quality Management System, incorporating the company’s Quality Policy, Management Commitment, Standard Operating Procedures, Risk Assessments, GAP Analysis, and Training Records.
We can carry out an assessment of your business, advising and assisting with the production of a Quality System that will describe your procedures, meeting the requirements of the Guidance, and satisfies the requirements of the MHRA Inspectorate.
We can also help you to maintain your quality documents to ensure that they remain current and compliant.
Why Consider Us for Quality Management Systems?
We are all experienced in building and implementing Quality Management Systems and can assist at any stage of the Quality Management System build process. Having helped many clients to establish bespoke Quality Management Systems, we have a wealth of knowledge and understanding of both regulatory and business requirements.
We offer advice and services relating to:
- Quality Systems ( creation & maintenance)
- GAP analysis, creation of action plans, validation
- Audits including pre-inspection audits
- Personnel, Contract RP Services, Training & Refresher Training
- Premises, including temperature mapping and control
- Product Recalls
- Technical Agreements
- Complaints & Falsified Medicines
- Third Party Contracts
For further information contact us.
We also offer GDP/RP training courses.
Please click on the links below to view full details of each case study.
Since 2012 we have been using PCL for regulatory support, staff resourcing, training and general advice. We have consistently found that the whole team has a high level of technical competence, are always willing to get stuck in to help us and are able to come up with robust ideas to improve our systems. I would have no hesitation in recommending their services in any of these areas.
Pharmacy Consulting provided us with a very professional and efficient service over a number of extremely busy months. Not only were they flexible to our requirements but also to our workloads, time schedules and finances. Jackie Peck in particular was extremely aware of our needs and outcome requirements. For a small company such as ourselves this was invaluable. At all times Pharmacy Consulting kept us informed of any amendments, changes, monetary matters and as the client we felt it was a very professional service. The intended outcome was successfully achieved and the team at Pharmacy Consulting went above and beyond their duties as consultants for us. I cannot recommend them enough.
The day was fun and I enjoyed the review of GDP requirements!
Pharmacy consulting helped us to map our warehouse and also to map our new pharmacy fridge they were much cheaper that the other quotes we had and they also trained up the staff on the cold chain SOPs we had jointly written. Thank you Jackie for all your help!
Pharmacy Consulting have provided our business with excellent support, advice and training with regard to obtaining Wholesale Dealers Authorisation following the implementation of European Commission Guidelines of 5 November 2013 on Good Distribution Practice, 2013/C 343/01. I would like to personally thank Dawn and her team for her personal assistance in securing the authorisation.
As a busy family run logistics business we are really grateful for the expertise of Pharmacy Consulting who came alongside us, pulling out all the stops to meet tight deadlines and helping us to elevate the standard of our Quality System. Thanks to the assistance of Jackie and her team, we are now able to satisfy the exacting standards of larger pharmaceutical wholesalers thereby improving our offerings to our clients and opening up new avenues for our business in the future. Steven DaviesDavies International Transport Limited
I think the PCL course dovetails very well with wholesaling as it provides practical course material with a good eye to Quality Management, which is the concern of our company with the MHRA inspection process beginning soon.
Pharmacy Consulting have provided us with a prompt and professional service, including advice, GDP training and helping us with a robust customised Quality System.During this time they have been committed to fully understanding our company needs and have consistently delivered excellent service.I would highly recommend PCL to any business for peace of mind and sound professional advice. Ben FunnellDirectorUniversal PS
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!