Audit

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...

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...

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...

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...

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...

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

• Management Review
• Validation and Qualification
• Risk Management
• Laboratory Controls
• Batch Review
• Quality Engineering
• Exceptions
• Post Market Surveillance

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