GMP News - APIs and Excipients

In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.

The WHO has published a draft document on "Environmental Aspects of GMP" and plans to include the topic of waste and wastewater management into GMP Guidance.

Based on the updated information from the CDC, the FDA pointed out the current risk assessment for the transmission of Zika virus through blood, cell or tissue products at the end of February.

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

The EDQM has published four updated Public Documents on the revision, renewal or re-application of a CEP. Here you can find out what has to be considered when describing an API and its quality in a CEP application.

In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".

In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.