Regierungspräsidium confirms and extends manufacturing license according to §13 AMG
A manufacturing licence under Paragraph 13 of the AMG is also required for the carrying out of changes to the secondary packaging and package leaflets of medicinal products, since such activities fall within the concept of "manufacture" in the pharmaceutical sense.
Since September 2018, the Grieshaber Logistics Group AG (GLG) has maintained the manufacturing licence in accordance with §13 AMG and the associated GMP certificate. The documents issued by the authorities can be accessed in the publicly accessible EudraGMDP database. The licence number is: DE_BW_01_MIA_2018_0077; The GMP certificate number is: DE_BW_01_GMP_2018_0141. The validity of these documents was monitored and confirmed in July 2020 by the Regional Council of Tübingen by means of a GMP inspection.
The pharmaceutical customer has several significant additional benefits from this constellation:
- The quality management (QMS) GLG is on a high level comparable to a pharmaceutical company
- GMP compliance is regularly monitored and confirmed by the authorities, this is an additional assurance for the customer that the GMP requirements are met
- Additional activities on pharmaceuticals, such as repackaging, labelling or exchange of package inserts can be carried out by GLG, thus avoiding unnecessary transport routes to external contract packers, for example
- Integral integration of GLG into the pharmaceutical supply chain. GLG as a partner beyond the pure logistical handling
- GMP also includes GDP. The official supervision does not only apply to the pure manufacturing activities. The QMS is monitored in its entirety, thus all pharmaceutical customers benefit, even if no specific production is carried out under contract
Grieshaber thus continues to prove itself as a reliable partner with "add on's" all along the pharmaceutical supply chain.