Audit

Audit Companies (6)

Audit News

Audit Products (8)

  • Product Rephine’s GMP Audit Reports

    Rephine provides personalised, detailed and comprehensive GMP audit reports that are recognised and accepted by QPs and regulatory authorities around the world. The Rephine list of audit reports is updated regularly.

    If the audit you require is not on the list, you can review the Rephine Audit Plan...
  • Product Audits

    Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due dilig...
  • Product Pharmaceutical Auditing Services

    Auditing services for the pharmaceutical industry: Our pharmaceutical audits are conducted in accordance with the relevant regulatory texts or standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufacturin...
  • Product Good Clinical Practice (GCP) auditing services

    Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
    Rephine’s portfolio of GCP services incl...
  • Product Commissioned GMP Audits

    Rephine’s commissioned audit service gives our customers the opportunity to work with us to design exclusive audits tailored to the specifics of their operations. Customers can commission various audits including:

    -API Manufacture-Excipient Manufacture
    -Investigational Medicinal Product (IMP) Manu...
  • Product Inspection Readiness & Support

    • Inspection Event Planning
    • Personnel Training and Interview Preparation
    • Subject Matter Expert Support
    • Post-Inspection Analysis
  • Product Quality Operations Support

    • Management Review
    • Validation and Qualification
    • Risk Management
    • Laboratory Controls
    • Batch Review
    • Quality Engineering
    • Exceptions
    • Post Market Surveillance
  • Product Health Authority Enforcement Response & Remediation

    • FDA/EMA/Health Authority Agency Intelligence
    • Rapid Response to Inspections
    • Remediation Support
    • On-Site Remediation Project Management
    • Coordination with Regulatory Counsel
    • Third-Party Support

Upcoming Events

  • CPHI Korea 2022

    COEX, Seoul, Korea
    28 - 30 September 2022
  • CPHI Frankfurt 2022

    Messe Frankfurt, Frankfurt, Germany
    1-3 November 2022
  • CPHI & PMEC India 2022

    India Expo Centre, Greater Noida, Delhi NCR
    29 November - 1 December

Pharmaceutical Industry Webinars