REGULATORY INSPECTION PREPARATION

We can assist by undertaking a pre-approval inspection or mock inspection and gap analysis prior to the inspection by the regulatory agency. Our team of auditors have experience of over 60 regulatory inspections undertaken by various agencies including the MHRA (UK), HPRA (Ireland), EMA, SUKL (Czech Republic), FDA (US), Korean FDA, Turkish MOH, MCC South Africa, Anvisa Brazil, at sites in Argentina, Bangladesh, Czech Republic, England, India and Ireland.

We offer services such as:

  • Conducting pre-approval regulatory inspections in all areas of GxP.
  • Conducting mock regulatory inspections in all areas of GxP.
  • Provide guidance on corrective actions to be implemented and validated prior to the regulatory inspection. This will give you the opportunity to rectify any issues prior to them being cited as regulatory non-compliances by the inspector.
  • Provide training on how to prepare for a successful regulatory inspection, including mock inspection interviews, and the ‘Do’s and Don’ts’ of hosting and interacting with regulatory agencies.
  • Inspection readiness reviews – especially important now that unannounced inspections are becoming more frequent.
  • Reviewing level of compliance with best practice standards with a view to applying for, renewal or retention of the necessary appropriate licences, such as MIA, WDA, MA, GMP and GDP.
 

COMPUTER SYSTEM AUDITS

We provide guidance on how computer systems should be validated to meet cGMP requirements and/or provide highly independent audits to assure your computer software vendors also meet the requirements to ensure a GMP validated system

 

GENERAL cGMP COMPLIANCE AUDITS

We provide cGMP Compliance Audits to you on a one time or annual basis. We conduct highly independent and impartial audits and provide reports to you with suggestions for improvement

 

QUALITY SYSTEMS REVIEW

Compliance to GMP can only happen if there is a strong and well-defined Quality System. Unfortunately, with the ever-changing legislative requirements, it is not always easy to maintain a Quality System that meets the current requirement. Through the use of our services we can ensure that your Quality Systems not only meet current requirements, but are prepared for any new requirements that are currently going through the Regulatory consultation process.