Conducting an assessment of the site's readiness to meet Russian or EAEU GMP requirements prior to submitting an application.

Goal: identifying discrepancies before GMP application submission and inspection.

Format:

• On-site or remotely (based on documentation and video coference)
• Preparation of an Inspection report with classification of non-conformities (critical, major, minor)
• Recommendations for CAPA actions

Preparation of a complete set of documents and submission of an application for inspection:

• Ministry of Industry and Trade of the Russian Federation
• Rosselkhoznadzor
• Regulatory authorities of the EAEU countries (Ministries of Health, authorized bodies)

The service includes:

• Preparation of the application forms and supporting documents.
• Verification of the dossier (Site Master File, product list, Normative documents etc.)
• Translations and apostilles (if necessary)
• Interaction with the regulator until the inspection is scheduled

Remote or on-site support during GMP inspections:

• Selection of qualified and competent interpreters with knowledge of GMP terminology.
• On-site support (if necessary, communication with plant employees and inspectors)
• Support during remote inspection (connection to sessions, monitoring of questions/answers)
• Support for the customer/applicant in responding to clarifications or requests from inspectors team.

Goal: increase the chances of a positive conclusion following the GMP inspection.

If non-conformities are identified during GMP inspection:

• Analysis and classification of non-conformities
• Support with preparation of a corrective and preventive action (CAPA) plan
• Monitoring of the implementation of CAPA actions
• Preparation of a response to Health Authorities (if required)

In cases of a negative conclusion or planned resubmission:

• Analysis of previous non-conformities
• Updating of nessecary documentation
• Support in the second GMP application submission cycle

Conducting individual and group training sessions:

• Training on the specifics of conducting/passing EAEU GMP inspections
• Organizational aspects, personel behaviour during inspections
• GMP sessions and webinars for your teams based on an external partner from leading GMP experts.