Qualified Person Services
Many of EPiC’s consultants are eligible to act as a Qualified Person and we have contract QP’s supporting a number of licenced manufacturers certifying products prior to release to the market.
In Depth Systems Reviews
EPiC’s consultants have been working with two large UK based pharmaceutical manufacturers conducting in depth reviews of their pharmaceutical quality systems. In contrast to an audit which involves sampling documents and records these reviews focus on a particular system, process or procedure with the goal of assessing it in detail against regulatory guidance and expectations. Each review takes between 2 to 3 days with the programme covering 12 to 18 months.
Post Inspection Remediation
As ex Inspectors many of EPiC’s Consultants have extensive experience with the MHRA Compliance Management Team (CMT) and Inspection Action Group (IAG) processes. EPiC Auditors regularly support companies who have been referred to CMT or IAG; leading Root Cause Analysis workshops, advising on the response to the inspection findings, developing remediation plans and assisting with implementation.
Review of Pharmacovigilance System
Following a change of ownership and transfer of Marketing Authorisations an EPiC consultant specialising in Pharmacovigilance has undertaken an assessment of the companies’ systems for compliance with current regulatory and MHRA expectations and made recommendations to strengthen them.
Support for Overseas Manufacturers
EPiC’s Consultants are currently working with an overseas manufacturer who wants to supply medicinal products to the UK and Europe. Starting with a gap analysis of the companies Pharmaceutical Quality System improvements will be made to meet EU GMP requirements. A mock EU GMP inspection will then be performed prior to the company triggering a regulatory inspection.
Routine Compliance Audits
A number of clients request regular compliance audits of their facilities and systems in order to supplement their own internal audits and attain an independent assessment. Audits are conducted against EU GMP and GDP with any deficiencies and opportunities for improvement being highlighted. When requested EPiC’s consultants assist with the implementation of corrective and preventative actions.
If you need our help and support then please contact us on +44 (0)1244 980544