Mock Regulatory Inspections
Former regulatory Inspectors can perform mock EMA, EU, MHRA or FDA inspections to assess the readiness of a company to successfully host a regulatory inspection, or as part of an initial gap analysis as a site embarks on preparation for such an inspection
GMP (Good Manufacturing Practice), GDP (Good Distribution Practice) PV (Pharmacovigilance), GCP (Good Clinical Practice) and GLP (Good Laboratory Practice) audits are a core specialty using ex Regulatory consultants.
Supply Chain Audits
The entire supply chain and product life cycle can be audited from starting material manufacturers, API manufacturers, excipient suppliers, packaging suppliers, clinical development, medicinal product manufacturers and contract manufacturers, EU importation and testing through to QP certification activities. Virtual companies (who also need an excellent Pharmaceutical Quality System) are a particular area of expertise.
Due Diligence Audits
Performed in relation to merger and acquisition activities can be provided. Typically, of a shorter duration these audits will rapidly identify potential issues and gaps in relation to current industry and regulatory standards.
‘For Cause’ Audits
Often performed in response to an incident such as a recall, complaint or adverse regulatory inspection finding.
Pharmaceutical Quality Systems
The success of a company is founded on the design and effective operation of its Quality System. EPIC Auditors can provide an evaluation and assessment of a company’s Quality System and advise on its design and monitoring so that it is fit for purpose.
Self-Inspections / Internal Audits
These audits are often not performed with the full vigour and robustness they require. An efficient Self-Inspection/Internal Audit programme should result in no regulatory inspection findings! How often does that happen? EPIC Auditors can perform a critical evaluation of the Self Inspection System or conduct ad hoc audits as part of a site/company Self-Inspection system.
Audit Programme Management
EPIC Auditors can perform external and /or Self-Inspections on behalf of an organisation. EPIC Auditors plan and perform the audits against the annual audit schedule freeing up company resource and QP time whilst ensuring that all your audits are performed in accordance with the latest regulatory expectations.
MIA /WDA Licence Applications & Variations
The manufacture, importation and distribution of medicines in the UK can only be carried out by appropriately authorised companies. As many of EPIC Auditors consultants are Ex MHRA Inspectors we can advise and support with applications for a Manufacturing Import Authorisation (MIA) or Wholesale Distribution Authorisation (WDA).
Active Substance Registration Applications & Variations
The manufacture, importation and distribution of active substances in the UK can only be carried out by companies registered with the MHRA. As many of EPIC Auditors consultants are Ex MHRA Inspectors we can advise and support with the application for an active substance registration.
Contract Qualified Person (QP) Services
EPIC Auditors has consultants who are eligible to act as a Qualified Person. We can provide contract QP services to support licensed manufacturing and / or importation activities and certify products prior to release to the market.
Former regulatory Inspectors can assist companies return to an acceptable state of compliance following adverse regulatory findings or action, ensuring corrective and preventative measures are robust and aligned to the latest regulatory expectations. Previous clients have included large contract manufacturers both in the UK and overseas, major multinational pharmaceutical companies and UK specials manufacturers.
In Depth System Reviews
More detailed than an audit; EPIC Auditors can conduct detailed reviews of systems, processes and procedures e.g. Sterility assurance control strategy, Senior Management Quality Reviews, Supplier approval process, Validation Master Plan, against current guidance and regulatory expectations, identify any gaps and weaknesses and put together an improvement plan.
In House Workshops & Coaching
Drawing on their knowledge, skills and experience EPIC Auditors can deliver workshops and coaching on all aspects of GXP compliance.
Preparing for and hosting a regulatory inspection can seem very daunting. As many of EPIC Auditors consultants are Ex MHRA Inspectors we can assist with inspection preparation, advise on what to expect during the inspection, highlight what documents should to be readily available, provide coaching on how to respond to the inspectors questions and give guidance on how to reply to the post inspection letter.
Desk Based Reviews
Many elements of a Pharmaceutical Quality System can be assessed and appraised remotely. We can review and comment on a wide range of documents including standard operating procedures, protocols, deviation reports, work instructions and audit reports, checking their suitability, compliance with the regulations and that any conclusions are valid and supported by the data presented.
EPIC Auditors has a suite of Standard Operating Procedures that can be used by companies as templates for more bespoke procedures as part of their own Pharmaceutical Quality System development. EPIC Auditors can assist with customising these to fit with client processes.
Advice, Support & Guidance
EPIC Auditors has a broad range of experience across all aspects of the product lifecycle. This includes supporting new companies during the initial stages of product development into clinical trials, through commercial manufacture and distribution to advising on post marketing commitments and pharmacovigilance. Assessing risk and managing non-compliance is also an area of expertise. EPIC Auditors can provide advice, support and guidance on all manner of regulatory, quality assurance and pharmaceutical quality system questions or issues and help you comply with your regulatory obligations.
If you need our help and support then please contact us on +44 (0)1244 980544