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.
I am glad that I contacted Pharmacy Consulting Limited (PCL). Jackie Peck helped me in understanding all aspects of community and internet pharmacy. She was helpful in conducting survey, preparing business plan and negotiation with wholesalers etc. She was extremely approachable and provided invaluable advice. She was proactive in helping and was very flexible. I will highly recommend Pharmacy Consulting Limited to all especially young entrepreneurs. It is a money well spent.
” Very interesting presentation which allowed me to gain a proper overview of the GDP process”Jack – Course Rating 9/10
“Very informative training day.”“Highly recommended”
“Excellent, personable and very informative”Anonymous – Course Rating 10/10
“The training was informative, covering all areas.”Anonymous – Course Rating 10/10
Informative and enjoyable. Lots of new avenues identified as resources. Thanks!
“A lot of valuable information to digest! Thank you.”Anna Drys – Course rating 9/10
“Brain is very thorough and very informative. Interactive too. A++++, Highly recommended”Anonymous – Course Rating 9/10
“A very small group (2 of us attending) but this was excellent! Very interactive course, very informative. Gained a lot of information to take away. Thank you very much.”Jane Lytwynchuk – Course Rating 10/10
/”Very informative and put in an easy to understand way. The course was explained so I can say i left feeling that I understood my role going forward. Thank you.Marie Wakeham – Course Rating 9/10