Working within GxP frameworks requires a system of both self inspection to ensure the QMS and it’s SOPs are being consistently applied and followed and all deviations and changes recorded, investigated with appropriate risk management procedures applied. There is also the requirement to validate suppliers and materials of manufacture.

We have systems for the management of audit programs and can perform audits of manufacturing sites, packaging sites, distributors, API and raw material suppliers and contract laboratories including to ISO9001 and ISO13485.

We can advise on programs for self inspections, and we can also provide independent inspection services to ensure your GxP compliance. This may be appropriate for providing GAP analysis before any competent body inspection.