GMP NEWS 2017

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter <1225> Validation of compendial Methods. Read more about the Validation of Analytical Procedures.

On 17 January the US FDA published a draft guidance on "Labeling of Red Blood Cell Units with Historical Antigen Typing Results". It is now open for comments.

The ICMRA has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and FDA.

Since January 2013 all imported APIs need to be accompanied by a so called "Written Confirmation" (except a few countries with equivalent GMP standards like the US and Switzerland) which should confirm that the manufacturing site is working under GMP (ICH Q7). But how much does the system help to improve quality of APIs. An investigation of written confirmations issued by the Indian Authorities reveals some surprises. Read more about the Written Confirmations for APIs.

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

FDA's CDER has published a Guidance Agenda with planned new and revised Draft Guidances for 2017. Some of the planned FDA Guidances could be interesting for the GMP area.

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.

As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.

The ICH recently published a reflection paper on “GCP Renovation” regarding the modernization of ICH E8 (General Considerations for Clinical Trials) and the subsequent renovation of ICH E6 (Guideline for Good Clinical Practice). Read more about ICH´s Reflection Paper on the potential renovation of the ICH guidelines related to clinical trials.