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
  •     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.

Testimonials

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.  
Testimonial From Integro Pharmacy - David Hammond