English to Russian Medical Medical: Pharmaceuticals

Answer any general enquiries during the opening meeting e.g. general aspects of each department’s responsibilities relevant to the inspection agenda.
QA Manager (or delegate) / Responsible Person named on the license
4.2.5
Attend to the inspector(s) throughout the entire inspection, answer all QA-related queries truthfully and provide requested documents or descriptions.
(Refer to Appendices A and B)
4.2.6
Should the inspector(s) request samples of drug, product or labels, inform them that **the details will be taken** and, if acceptable to the client and senior management, the materials will be supplied to the inspector at the end of the inspection.
Request a receipt for samples provided to the inspector.
This request must be documented in accordance with local regulations.
Note that if local regulations do not require permission of the client to take samples then the client and Marken senior management must be notified before the samples are removed from the site.