We are often approached by both new and existing Wholesale Distributors who require assistance with creating or updating their Quality System. In some cases there is an existing certificated ISO system in place which need to include the specific processes, procedures and forms that are required for the procurement, holding and distribution of medicinal products.
The Pharmacy Consulting Solution
In all cases, we carry out an on-site GAP Analysis of the client’s Quality System (where there is one in place) and activities against the Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01). We assess and record any current or planned processes & procedures and review any existing, relevant, Quality System Documents. From this, we are able to help the client establish a new or updated Quality System that meets the requirements.
Using the above procedure, we ensure that all our Quality Systems are unique and reflect the actual procedures being used or planned by our clients.
We also provide training days which give an insight into the requirements of the Guidelines in respect of the Quality System.
With our input and assistance, our customer’s Quality System meets the requirements of the GDP Guidelines. With the benefit of our training and advice, our customers are able to review and maintain their Quality System and make improvements to their business.
With a robust Quality System in place, our WDA (H) holders are more likely to obtain and retain their Authorisations.