During the Covid 19 pandemic, like the MHRA, and like many other businesses, EPIC Auditors has been providing remote support and auditing. Helping companies to meet the regulatory requirements and to develop the quality systems essential to support much needed clinical trials for various Covid 19 treatments.
As part of this facilitation work, EPIC have developed a set of generic SOPs for key elements of the quality system that companies can then adapt to their own business framework and style. We now have a set of 10 SOPs covering:-
- Quality Management Reviews
- Change Control
- Quality Risk Management
- Self – Inspection
- Supplier Evaluation
We also have a set of SOPs specifically for manufacturers of IMPs covering:
- Importation of IMPs
- Batch Certification
- Reference & Retained samples for IMPs
Please let us know if you are interested in these, using the same e mail address.
In addition to providing support for Covid trials, we have also adapted to providing routine remote audits of all kinds including internal audits and supplier audits as well as mock MHRA inspections. Advances in technology are helping us to overcome the challenges of remote auditing but it is likely that the efforts will not be wasted, as remote auditing is probably going to be with us for some years to come.
If you need our help and support then please contact us on +44 (0)1244 980544