EU cGMP Certification
Megainpharm GmbH core activities are tightly related to medicinal products production and distribution within the territory of Russia and the EU. These processes require confirmation of compliance with applicable standards in order to obtain appropriate certificates, including Marketing Authorization. Main standard requiring compliance certification is called Good Manufacturing Practice – GMP. EU GMP certificate is issued on the basis of competent authorities’ decision formed upon completing an inspection with the goal to examine and confirm the compliance of all aspects of production, including personnel qualification, with applicable requirements.
Obtaining an EU GMP certificate offers the following advantages:
- Basis for entrance to foreign markets, obligatory requirement for commercial release of the product;
- Systematic approach to the management of critical and supportive production processes;
- Commitment to constant improvement through risk management, trend and deviation analysis;
- Process optimization;
- Raising confidence before state inspections due to routine activities regarding determination, implementation and monitoring of requirements of laws and other applicable regulations;
- Building up a positive image among contract partners, investors, customers, competent authorities;
- Credibility from international corporate customers.
Megainpharm GmbH is experienced in obtaining EU GMP for pharmaceutical sites, which allows us to provide support and services in regard of this procedure to our clients. Our company provides assistance at all stages, starting from documents preparation and execution to design of training programs and personnel certification. Another main point of concern is preparation for state inspection, which is the most crucial stage with the results of the inspection defining if the EU GMP certificate is granted or not. Megainpharm GmbH offers a preliminary GMP audit before the state inspection in order to train the personnel and reveal possible incompliances, as well as inspection accompaniment by qualified personnel.
We provide the following services in obtaining an EU GMP certificate:
- Preparation and execution of relevant documents;
- Adjusting production processes to required standards;
- Preparation for state inspection;
- Inspection accompaniment by an expert;
- Personnel training and integrating EU cGMP standards in production process.