ITsQA provides independent consultancy and pharmaceutical auditing in the area of Good Vigilance Practice (GVP), providing assurance of compliance with ICH and applicable global regulatory requirements (GVP Audit service).
In EU GVP Module III*, In order to determine that marketing authorisation holders comply with pharmacovigilance obligations for products with a license within the EU, and to facilitate compliance, competent authorities of the Member States concerned shall conduct, in cooperation with the Agency, pharmacovigilance inspections of marketing authorisation holders or any firms employed to fulfil marketing authorisation holder’s pharmacovigilance obligations.
In EU GVP Module IV**, the definition of an audit is a systematic, disciplined, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled which is also the definition as defined in ISO 19011 (3.1).
European Legislation on pharmacovigilance in July 2012, established legal requirements for marketing authorisation holders to perform audits of their pharmacovigilance systems [DIR Art 101(2), Art 104(2), REG Art 28f], including risk based audits of their quality systems [IR Art 13 (1), Art 17 (1).]
ItsQA help prepare you for such an eventuality by carrying out audits and 'mock' inspections of your organisation.
It'sQA auditors are qualified and experienced in conducting audits of all systems, processes in pharmacovigilance. Not being involved in your company’s daily activities enables It'sQA to conduct truly independent audits with no conflicts of interest.
We can help you develop and deliver a complete audit programme for pharmacovigilance or simply help with aspects of GVP audits.
Common audits include:
- System Audits (headquarter and affiliate)
To provide assurance that all procedures have been carried out and that company and regulatory expectations are being fulfilled.
- License Partner Audits
To provide assurance that partners of company are adhering to contractual and regulatory obligations while marketing your products in their territory.
- Assessment audits of CROs and other Vendors
Independent audits of CROs prior to contract placement to give assurance that the organisation is fully compliant with pharmacovigilance and able to provide the service required. Re-qualification audits to ensure level of services is maintained
Global GVP audits
We have conducted pharmacovigilance audits all over the world including: Belgium, Canada, Croatia, Chile, Czech Republic, Denmark, France, Germany, Great Britain, Holland, Hungary, India, Ireland, Israel, Italy, Japan, USA, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Sweden, Turkey, Ukraine, China, Estonia, Netherlands, Australia, New Zealand, UK, UAE, Oman, Qatar, Lebanon, Ecuador and Panama.
* 8 September 2014 EMA/119871/2012 Rev 1 Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 1)
** 12 December 2012 EMA/228028/2012 Guideline on good pharmacovigilance practices (GVP)
Module IV – Pharmacovigilance audits