GMP NEWS 2022

The CMDh has revised and published its Q&A document on the QP Declaration.

Because there is no existing USP monograph for this drug substance, a new monograph for Cannabidiol (CBD) is being proposed. It defines that CBD is obtained from Cannabis sativa.

Wholesale trading of medicinal products in Germany requires an authorisation according to Section 52a of the Medicinal Products Act (Arzneimittelgesetz – AMG). The holder of the authorisation must notify the competent authority in advance of any fundamental changes. A wholesaler from Brandenburg, Germany, did not comply with this notification requirement, as a GDP Non-Compliance Report published in October 2021 shows.

In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers' team.

Stainless steel is predominantly used in pharmaceutical equipment engineering. The 316L variant is basically regarded as standard; material incompatibilities of the steel with the product are more or less neglected. This is different with plastics. In addition to leach-out, aging and surface finish, other quality characteristics are often specified. But are there generally applicable requirements for plastics in pharmaceutical equipment engineering?