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.”