GMP News - APIs and Excipients

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

Raw materials used in the manufacture of biopharmaceuticals may show highly different characteristics and risk potentials. Read here why and how risk assessments for raw materials must be performed and where practical advice therefore may be gained.

API manufacturers who want to make changes to the API manufacturing process during an application's post-approval period should read FDA´s new draft guidance for industry: Postapproval Changes to Drug Substances.

The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.

Facilities supervised by the FDA should pay great attention to GMP-compliant processes, especially in the areas of manufacture and quality control; otherwise, they risk failing the inspection and receiving a warning letter. Find out what defects regarding document management and analytical software FDA inspectors found at the site of an active substances manufacturer.