GMP Consultancy: Addressing Critical and Major Inspection Deficiencies

UK Based Manufacturer of Aseptic Unlicenced Medicines On-site and Remote Support

Project Brief:   

Aseptic

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.” 

Ready to Transform Your GMP Compliance?

Are you facing critical or major inspection deficiencies? With EPiCs help, succeeding with meeting regulatory standards is not only straightforward but an opportunity to excel.

🌐 Leverage our Expertise:

  • Comprehensive on-site and remote support providing a broad range of expertise from former MHRA inspectors and industry specialists.
  • Tailored audits of your systems, processes, and procedures with recommendations that direct your compliance strategy.
  • Enjoy bespoke resources, from SOP assessment to staff training, designed to close knowledge gaps and enhance your operational excellence.

Embark on Your Path to Compliance Mastery: Connect with us now and start your journey with a partner who brings clarity to complexity and assurance in action to your GMP compliance strategy.