Our Company provides services for voluntary pre-inspection audit for pharmaceutical companies to meet the requirements prescribed by due manufacturing practice rules (Order of the Ministry of Industry and Trade of the Russian Federation No. 916 of June 14, 2013) and provide recommendations regarding elimination and correction of any inconsistencies.
The audit of the Customer is performed under ISO 19011:2012 Guidelines for auditing management systems (IDT) and generally consists of three phases:
- evaluation and reporting.
Before starting the audit, a group of auditors should mandatory sign the confidentiality agreement with the customer.
Management of the customer provides the objectives of the audit program.
The audit program includes information and resources necessary for the organization of the audit and its effective and efficient conduct during the planned time-table and also includes:
- objectives of the audit
- scope, type, location of the audit
- plan and schedule of the audit
- program procedures of the audit
- audit criteria
- audit methods
- formation of audit group
- processes related to data protection and etc.
This stage includes introduction and work on Site Master File of the customer and other necessary documents. Allocation of roles and responsibilities within the audit group, preparing of the documents.
Luzhnetskaya embankment, 6, building 1