Are you operating with a comprehensive Quality System?
Chapter 1 of the Good Distribution Practice guidelines (EU 2013/C 343/01) states:
Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities.
A well written Quality System should set out clear responsibilities and processes in relation to the activities being performed.
The overarching aim is to reduce or eliminate errors, waste and non-conformance to the guidelines whilst meeting the expectations of the customer.
Quality System Documentation
It is important to get the documentation right the first time as failure to so do can cost time, money and confusion within the organisation.
Many Quality Systems are badly written and comprise of encyclopaedic volumes of documentation when they should be concise and easy to read.
A typical wholesale distributors quality system comprises of the following:
- Quality Manual
- Quality Policy
- Quality Risk Assessment
- Records and Forms
Bespoke Quality Systems
We believe every business is unique and thats why we tailor our services.
When we are commissioned to develop a quality system, we spend quality time with you to ascertain your business model and its current position in relation to what you want to achieve.
Our information gathering process ensures your strategic objectives and business model are incorporated into the Quality System and for maximum benefit we encourage your active participation from the very beginning.
We will also provide a ‘soft copy’ of the completed Quality System to enable you to keep it updated using the document control procedures in place.
Is your Quality System up to the mark?
Have you got a Quality System in place?
If you already have, is it fit for purpose?
Rather than wait for an inspection to highlight issues and get caught in ‘no mans land’ we suggest every business should have a GAP Analysis performed on their Quality System and Operations.
Pharma Experts GAP Analysis provides a full assessment of your current Quality System against what is actually required by the MHRA.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.