+7 996 716 83 66
Certification and licensing
Carrying out a set of measures for the purpose of licensing and certification of production sites for compliance with the requirements of GMP of the EAEU.
Work Stages
Documentation Analysis
Analysis of the production site available documents
Study of primary information about the production site and customer requirements
Development and preparation of the documents package in accordance with regulatory requirements
Preparation and approval of the audit program with the customer, preparation of questionnaires
Study of primary information about the production site and customer requirements
Development and preparation of the documents package in accordance with regulatory requirements
Preparation and approval of the audit program with the customer, preparation of questionnaires
Audit Conducting
Evaluation of documentation, buildings and premises, organization of the production process
Evaluation of engineering systems, including GMP critical engineering systems (air preparation systems, water preparation and distribution, compressed gases, etc.)
Evaluation of equipment and pharmaceutical quality system
Assessment of production conditions, storage and medicines quality control
Evaluation of engineering systems, including GMP critical engineering systems (air preparation systems, water preparation and distribution, compressed gases, etc.)
Evaluation of equipment and pharmaceutical quality system
Assessment of production conditions, storage and medicines quality control
Accounting Documentation
Analysis of the information obtained during the audit, identification of inconsistencies with the requirements of GMP rules
Development of Corrective and preventive action plan (CAPA), preparation of recommendations for improvement
Preparation and approval of the audit report with the customer
Development of Corrective and preventive action plan (CAPA), preparation of recommendations for improvement
Preparation and approval of the audit report with the customer
Inspection Support
Analysis of inspectors' observations, provision of documents at the request of inspectors
Analysis of identified inconsistencies, development of the CAPA plan, information and methodological support of the CAPA plan implementation
Development of corrective and preventive actions
Analysis of identified inconsistencies, development of the CAPA plan, information and methodological support of the CAPA plan implementation
Development of corrective and preventive actions
Contuct Us
Phone/Whatsapp/Telegram
+7 996 716 83 66
E-mail
info@mpmadviser.com
