UK Based Manufacturer of Aseptic Unlicenced Medicines On-site and Remote Support
Project Brief:
EPiC received a request for support from a UK-based aseptic compounding unit to provide GMP consultancy to help the company respond to Critical and Major inspection deficiencies identified during a short-notice MHRA GMP inspection.
The project required a combination of on-site and remote support to deliver a comprehensive support package drawing on a range of expertise from our consortium of ex MHRA Inspectors.
What EPiC Did:
- We provided expert insight into the MHRA Inspection Action Group (IAG) referral process to ensure the client understood the patient safety risks and possible regulatory action outcomes available to IAG.
- We performed a remote review of the company responses to the inspection deficiencies raised by the MHRA and provided comments and feedback ahead of them being submitted to IAG.
- We conducted a deep dive end to end audit of the aseptic compounding unit systems, processes and procedures including compliance with the revised Annex 1 to identify GMP deficiencies, weaknesses, or compliance gaps along with recommendations to address them.
- Based on the outcome of deep dive end to end audit, we developed and supported the successful implementation of a holistic compliance improvement plan (CIP) which included:
- Assessment of existing SOPs to establish fitness for purpose and support with the development and implementation of all required SOPs to meet GMP and MHRA Guidelines.
- Provision of training and education to staff at all levels to address knowledge gaps and aid future development.
- Onsite and remote support to assess remedial actions to ensure the fulfilment of the commitments made to IAG.
- Provided guidance and support to establish and implement a Senior Management Review process to ensure effective oversight of the Quality Management System.
- Provided ad-hoc consultancy support for staff to present, discuss and resolve issues associated with the completion of MHRA commitments and compliance improvement activities.
- Provided ad-hoc mentoring and coaching for key individuals to support a range of routine activities e.g. deviations, change controls and other day to day challenging operational decisions.
Client Feedback:
“From the moment I spoke with EPiC, my anxiety levels fell and I knew that we were in safe hands.”
“It’s difficult to put into words the level of professionalism and expertise that EPiC consultants have provided throughout a very challenging period. The service has been outstanding, and from the initial meeting we have had total confidence in the team. I have no hesitation in recommending EPiC for any business or individual needing GMP support.”