GMP News - APIs and Excipients

The "How to do" document is one of APIC's many Best Practices Documents and has been upgraded to the current state of the art. Read here which practical recommendations in the implementation of GMP for APIs are included in the most recent version of the How-to-do document.

The minimum requirements for a robust production process are suitable facilities and equipment. Read here about what FDA inspectors identified as root causes for impurities and quality variations in the production of active pharmaceutical ingredients (APIs).

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.

During the inspection of an Indian active pharmaceutical ingredient manufacturer, European GMP inspectors were met with severe deficiencies. Read here, which violations of GMP principles for production, laboratory and handling of reference samples led to a Non-Compliance Report. 

Relating to the increasing use of nanomaterials in manufacturing and the possible following risks for manufacturing staff the WHO issued a new guideline document entitled "WHO guidelines on protecting workers from potential risks of manufactured nanomaterials" .

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.