Pharma audit support and GxP audit execution
We help you prepare for pharmaceutical inspections, or make sure suppliers are meeting your expectations.
We execute supplier audits, internal audits and assist your organization in pharma audit preparation or remediation.
Supplier audits allow for a complete evaluation of the supplier organisation, quality system, technical capability and key practices.
A typical pharma supplier can be audited in just two working days, as such benefits of conducting a supplier audit far outweigh costs.
An internal audit of your pharmaceutical facility, service or quality system by a consultant can identify issues which would remain undiscovered when relying just on internal auditors. We manage audits at your site in all discretion, in different fields of expertise.
We have experience setting up extensive pharma audit remediation programs, for example after a warning letter.
- General QMS aspects: document management, training, change management, CAPA, deviation & OOS
- Validation, C&Q
- Computerised systems: CSV, data integrity
- (Aseptic) production
- (QC) laboratories
- GMP, GDP, GCP and GLP (US and EU)
- Supplier qualification