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.
Several Ph. Eur. Monographs on excipients used in semi-solid formulations have been proposed for comment. Read more about the monographs on oils, fats, waxes, emulsifiers.
ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?
In the course of Brexit, the EMA has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. Read more about EMA's procedure for appointing new rapporteurs.
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.
Recently a post in the MHRA blog informed about common findings GCP Inspectors have seen across a number of recent inspections. Read more about Data integrity in Clinical Trials.
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 US Food & Drug Administration (FDA) has issued a Warning Letter to a US company recommending to have a look at FDA's Guidance on Contract Manufacturing Arrangements.
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.