GMP News - APIs and Excipients

Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comment on the USP Pharmacopeial Forum website.

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.

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.

The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

In August 2021, the new Commission Implementing Regulation (EU) 2021/1248 on measures on good distribution practice for veterinary medicinal products entered into force. Read more in the summary of the most important aspects of the new document.

The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.

Sampling of materials is one of the most important processes in pharmaceutical companies. An Indian company received a so-called 483 FDA report due to inadequate sampling plans for raw materials and intermediates. Furthermore, the FDA criticises that components used in manufacturing are not tested and released prior to use.