GMP NEWS 2019

The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.

FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy".

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

Seven months into the operational phase a significant number of manufacturers and supply chain actors have not yet connected to the EU verification system. Now, the EMVO stakeholders encourage the NCAs to undertake inspections on all supply chain actors.

The FDA´s Enforcement Report tracks and displays updates to recalls. The July 2019 listings contain several Class II recalls due to various cGMP deviations and two Class I ratings. One of the Class I ratings resulted from the finding of glass particulates in an injection.

The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website.