Audits

Professional support for global auditing 

GMP audits

  • Manufacturing of finished products, APIs and excipients
  • Packaging material production, based on ISO 15378
  • Medical device production, based on ISO 13485

GDP audits

  • GDP of wholesaling, warehousing and transportation activities

Vigilance audits

  • Pharmacovigilance activities, based on Good Pharmacovigilance Practices (GVP) for the European Union, GVP Modules and SDEAs
  • Vigilance activities, based on the European Medical Device Directive and MEDDEV Guidelines, especially MEDDEV 2.12.1.

Regulatory audits

  • Auditing critical processes in regulatory affairs, such as information flow and storage
  • Carrying out audits in SmPC and PL version control and packaging materials, checking updatedness of national databases

Mock audits

  • A mock audit helps you to improve your quality management systems and assess whether your operations comply with current legislation.

Internal audits

  • Assessing whether your operations comply with your operating procedures and if any updating is required
    • Within PV, for example, employees cannot audit themselves.

Remote audits

  • Sometimes onsite audits can be replaced by well-organized remote audits.
  • A remote audit consists of:
    • Pre-audit questionnaire and pre-material requests
    • Video interviews
    • Video document review
    • Audit report

 

Why to choose remote audit?

In case of pharmacovigilance, there are no site or workspace related issues to be audited, as is the case with, for example, GMP manufacturing sites. Therefore, document reviews can easily be done remotely. Local documents and SOPs are often in the local language, so auditors must rely on interviews. Outside EU, the local legislation is not as advanced, so the pharmacovigilance requirements come primarily from the PVA between the parties. In addition, remote audits are an eco-friendly and a cost-effective alternative as there are no travel or accommodation.

You may also be interested in the following services?

Quality Management Pharmacovigilance Regulatory Affairs    

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