audit

Compliance to cGMP, GLP or GCP does not depend solely on the company’s own organisation; compliance requirements are extended to the company suppliers.

Supplier audit is an essential part of the Supplier Qualification, which is becoming a crucial process of the Pharmaceutical Quality System (ICH Q10).

The audit provides the required evidence, and the desired confidence, of third party good practices and professionalism, resulting in products that will not affect adversely the level of quality and the compliance environment of the company.

GMP compliance requirements are increasing, from the already stringent case of active ingredients (API) to packaging materials and, to a certain extent, the excipients and other materials used in final dosage forms. Moreover, contract manufacturing is becoming a common practice, included in almost any outsourcing strategy…but it cannot introduce, in any case, new or increased risks to the patients’ health.

Additionally for other contract services: analytical, logistics, or computerized systems, the supplier audit constitutes a key activity to prove the “Quality by Design” of the future system and that the appropriate Life Cycle is applied to ensure a suitable validation.

 

  • General GMP audits
  • API, intermediates and excipients suppliers
  • Contract manufacturing
  • Contract laboratories
  • Transport and logistics suppliers
  • Software suppliers and integrators
  • R&D Outsourcing

For further information about Supplier Audits, please contact:

Eduard Cayón
ecayon@tdvct.com

Forum Auditorías