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.
Jackie is very knowledgeable, I have learnt so much from her in so little time. Thank you Jackie for being a fountain of knowledge!
A lot of valuable information to digest.Thank youAnna Drys – Oxford Hospital
“Very efficient and effective. Covered all areas of training.” – John Elliott KWE
‘Really informative, knowledgeable and interactive. Would recommend.’Rachel Bown
We appointed PCL to assist us with our new CQC compliance registration. From start to finish, they acted with professionalism and expertise; taking what at first seemed to be a tedious and daunting process and making it clear and easy to understand. Even after our successful registration, the consultant remained on hand to answer any outstanding questions and to ensure that we felt adequately prepared for a potential visit from the CQC. Having had such a positive experience, we have no hesitation in recommending PCL to any company who is considering their services
“Brain is very thorough and very informative. Interactive too. A++++, Highly recommended”Anonymous – Course Rating 9/10
Very useful day with a good overview of MHRA GMP & GDP process, procedures and roles and responsibilities.Isatec on site training – Andrew King
Very informative and delivered well. It was a good introduction into a subject I haven’t dealt with before. Jackie kept the course “light & breezy”
Very good informative trainer, excellent delivery on a rather dull topic. Kept our interest well which helped with learning. Jackie answered every questions I had. Thank you
“Excellent refresher, very informative. Thank you.”Addy Mohammed – Course Rating 10/10