Professional GMP compliance ensures the quality of drugs and active ingredients
The quality, safety and efficacy of medicinal products must be ensured to guarantee the well-being of the patients.
To ensure that medicinal products meet these high standards and comply with the requirements specified in the marketing authorization, the European Commission has defined quality standards of the production processes and environments for manufacturing medicinal products and active pharmaceutical ingredients in the EU GMP Guidelines and thus standardized them throughout Europe.
The EU GMP Guidelines require the creation of a quality assurance concept
These guidelines require that each manufacturer must set-up a GMP-compliant quality management system. The quality management system of pharmaceutical, active ingredient and excipient manufacturer must cover all quality-relevant areas and all quality assurance measures. The quality requirements do not only apply to production processes, but include all areas and measures of the company that have impact on the quality of the pharmaceuticals. Therefore, in addition to the general quality management principles, the personnel, premises, equipment, documentation, quality control, contract manufacturing, testing, complaints, product recalls and self-inspection must be properly controlled to ensure GMP compliance.
A manufacturing authorization and the corresponding GMP certificate
All companies worldwide must comply with GMP requirements in order to obtain a manufacturing authorisation (GMP certificate) for medicinal products or active pharmaceutical ingredients. Within Germany, the “Arzneimittel- und Wirkstoffherstellungsverordnung, "AMWHV” for Medicinal Products and Active Pharmaceutical Ingredients are governing the application of "Good Manufacturing Practice" and refers to the much more comprehensive European regulations.
Compliance to the GMP Guidelines
In addition to the management, responsible for the implementation of the PQS and the availability of the necessary resources, the management functions like Qualified Person (QP), Head of Manufacturing (LdH), Head of Quality Control (LdQC) and the Quality Management Representative (QMB) as well as the executing employees of the plant, suppliers and distributors are all together responsible for GMP compliance. They all must gain the necessary GMP knowledge and renew it regularly. Official inspectors from the competent authorities check whether companies produce in GMP compliance and can obtain, maintain or extend their manufacturing authorisation. The corresponding GMP certificate is issued after each successful inspection. The regular interval is every three years.
Valicare's Senior Consultants are experts in GMP compliance
Especially in the preparation for such inspections or when setting up or expanding company structures with regard to new products and markets, an objective external compliance check is valuable and goal-oriented. Often, the company lacks the corresponding experience or personnel resources to be well prepared here but a certain operational blindness or "old habits" can also lead to unpleasant surprises during the inspection by authorities.
Senior consultants of Valicare, who have gained many years of experience in the implementation of numerous and diverse GMP projects, are very familiar with the handling of quality assurance tools! They offer clients in the pharmaceutical and biotechnology industry, and especially manufacturers of advanced therapy medicinal products (ATMPs), comprehensive GMP compliance management for all project levels.
Our technical and regulatory GMP compliance management and consulting support is at the highest stage.
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