GMP NEWS 2018

To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.

Safety features, which will be mandatory in the future to put the Falsified Medicines Directive into practice, must be implemented by 9 February, 2019. The European Commission has published version 9 of their questions and answers on safety features in February 2018. Find more information on the EU's revised Q&A document on safety features.

The final GDP Guidance on Interpretation and Implementation has been published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group of the Chartered Quality Institute.

The final USP General Chapter <1210> has been published. It will become official on May 1, 2018. Read more about  Statistical Tools for Procedure Validation.

A new FDA guideline is supposed to help the industry in identifying suspicious or illegitimate products. All trade partners are asked to initiate specific actions if such products turn up. Find out more about the FDA instructions in suspicious and illegitimate products.

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.

The attempt to conceal hygiene deficiencies with inaccurate lab data resulted in a virtually inevitable Warning Letter after an FDA inspection. Read here, which violations of fundamental GMP rules for maintenance and cleaning of production equipment at an API facility were criticised by the inspectors.

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.

The long-awaited draft of the new Annex 1 was published in December 2017. Besides mainly contents concerning sterile production, it also contains various updates on the manufacturing and distribution of water to be used in pharmaceutical production.