TentaConsult Pharma & Med GmbH announced today that it has received the manufacturing authorisation for the batch release for market of sterile medicial products from the competent authority. This significant authorisation underlines the company's commitment to the highest quality and safety standards and marks another important milestone in the company's history.
The manufacturing authorisation for batch release to market is an official approval that allows TentaConsult to certify medicinal products following strict quality and safety tests. In accordance with Section 13 of the German Medicinal Products Act (AMG), this authorisation ensures that all manufacturing processes are carried out in accordance with Good Manufacturing Practices (GMP). The batch release is carried out by a Qualified Person (QP), who ensures that the products comply with the defined specifications and marketing authorisation dossier.
With the granting of the manufacturing authorisation, TentaConsult demonstrates compliance with the quality and safety standards of the pharmaceutical industry with its established quality management system. TentaConsult has explicitly emphasised the effective and efficient monitoring of the supply chain, the threads of which all come together at the batch release to market.
‘The granting of the manufacturing authorisation is a significant achievement for TentaConsult Pharma & Med,’ said Ralf G. Sibbing, Managing Director of TentaConsult Pharma & Med. ’This authorisation enables us to support our customers with an integral part in the supply chain – certifying their medicinal products and releasing them to market. This further strengthens our position as a trusted partner in the pharmaceutical and medical device industry. Our customers can be sure that they will continue to receive products and services of the highest quality from us.’
The manufacturing authorisation for batch release to market is an official approval that allows TentaConsult to certify medicinal products following strict quality and safety tests. In accordance with Section 13 of the German Medicinal Products Act (AMG), this authorisation ensures that all manufacturing processes are carried out in accordance with Good Manufacturing Practices (GMP). The batch release is carried out by a Qualified Person (QP), who ensures that the products comply with the defined specifications and marketing authorisation dossier.
With the granting of the manufacturing authorisation, TentaConsult demonstrates compliance with the quality and safety standards of the pharmaceutical industry with its established quality management system. TentaConsult has explicitly emphasised the effective and efficient monitoring of the supply chain, the threads of which all come together at the batch release to market.
‘The granting of the manufacturing authorisation is a significant achievement for TentaConsult Pharma & Med,’ said Ralf G. Sibbing, Managing Director of TentaConsult Pharma & Med. ’This authorisation enables us to support our customers with an integral part in the supply chain – certifying their medicinal products and releasing them to market. This further strengthens our position as a trusted partner in the pharmaceutical and medical device industry. Our customers can be sure that they will continue to receive products and services of the highest quality from us.’
