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01252 375362

[email protected]    /    01252 375362

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.

Quick Links

In a hurry? These links will help you to quickly find what you’re most interested in:

Our Pedigree

Examples and Testimonials from happy clients

GDP Guideline

Introduction to GDP/RP Training

Cogent Gold Standard Training

Audit Training

WDA Workshop

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
  •     Operations
  •     Product Recalls
  •     Pharmacovigilance
  •     Technical Agreements
  •     Complaints & Falsified Medicines
  •     Third Party Contracts
  •     Transportation
  •     Brokering

For further information contact us.

We also offer GDP/RP training courses.

Case Studies

Please click on the links below to view full details of each case study.

Quality System Build & Implementation

Testimonials

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.  
Testimonial from Seago Yachting- Dan Temple