GxP audits / assessments
As it is a regulatory expectation that pharma companies exert control over their entire supply chain, self inspections and third party audits may need to be performed. As auditing can be quite expensive, they should be performed to achieve the maximum returns and not just performed ‘for the record’ to satisfy the authorities.
Van Loosbroek Farma Consult have the experience and expertise in house to perform for clients Mock Regulatory Audits, Third Party Audits and Self Inspections of manufacturers of APIs, excipients, drug products, sterile and non sterile products, clinical trial materials, and wholesalers. These audits and inspections can be performed against various standards as GDP, GcLP, and GMP according to EMA and/or FDA requirements.
In consultation with the client we provide for each audit:
- a professional and detailed assessment of the state of compliance of the audited party;
- a comprehensive action plan to remediate the areas of noncompliance.