EAEU GMP Certification

Carrying out a set of measures (analysis and preparation of documentation, audit, support of the state certification procedure) in order to certify production sites for compliance with the EAEU GMP requirements.

Documentation Analysis:
- Analysis of the production site available documents
- Study of the production site and customer requirements primary information
- Development and preparation of documents package in accordance with regulatory requirements
- Preparation and approval of audit program with the customer, preparation of questionnaires

Audit Conducting:
Evaluation of
- documentation, buildings and premises, production process organization
- engineering systems, including GMP critical engineering systems (air preparation systems, water preparation and distribution, compressed gases, etc.)
- equipment
- pharmaceutical quality system;
- production conditions, storage and drugs quality control

Accounting Documentation:
- Audit information analysis, identification of inconsistencies with the requirements of GMP rules
- Recommendations for improvement and elimination of identified inconsistencies
- Preparation of the audit results report

Support of the state GMP inspection
- Analysis of GMP inspectors observations, documents provision at the request of inspectors
- Analysis of identified inconsistencies, CAPA plan development, information and methodological support of the implementation of the CAPA plan
- Development of corrective and preventive actions