Distribution of Medicines – Quality 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 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 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 Systems?
We are all experienced in building and implementing Quality Systems and can assist at any stage of the Quality System build process. Having helped many clients to establish bespoke Quality 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.
It was a great pleasure to deal with Pharmacy Consulting Ltd (PCL).I would recommend PCL to everyone especially young entrepreneurs about to embark upon owning their own pharmacy, be it in community pharmacy or Internet pharmacy.I valued the advice and motivation that PCL has given me to pursue my dreams.PCL’s knowledge in pharmacy regulation is vast and up to date and I will definitely use PCL again for my future projects
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.
“A lot of valuable information to digest! Thank you.”Anna Drys – Course rating 9/10
We loved your training at Niche!
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.
Just wanted to say thank you for the training last week, was education and fun, and it was great to be able to spend time with a professional auditor.
“Really well presented and explained. Have a much better understanding of a very involved subject.”Vicky Stones 10/10
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!
Very good overview of GDP requirements which has given me a much better understanding of client requirements for the services and products we supply.Isatec on site training – Bill Castle
“Very informative course. Well worth attending.”Dave Smith 9/10