GMP NEWS 2018

Following the committee meeting at the end of September 2018, the PIC/S working group had elaborated a new guideline on the classification of GMP deficiencies which is going to be adopted.

The first inspection of an Indian pharmaceutical company ended with the worst imaginable result. Read more about the GMP violations found by the European inspectors with regard to documentation management, cleaning and process validation, as well as further violations of GMP basic requirements.

Data integrity plays an exceptional role in clinical studies. On 23-24 October, 2018, the US FDA and the British MHRA hosted a joint workshop on this topic. Learn more about the contents and results of the joint workshop "Good Clinical Practice: Data Integrity in Global Clinical Trials - Are we there yet?"

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

Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.

A new international technical committee ISO/TC 313 Packaging Machinery has been founded, which will be responsible for establishing international standards for packaging equipment and systems.

What are the supply chain and drug shortage problems often caused by GMP and quality related problems? To find out more about this issue and about the consequences of drug shortages on the key stakeholders - i.e. the patients, companies and the governments -  the ECA conducted a survey. It also addressed potential strategies industry and authorities can employ to minimise the risk of drug shortage or its impact. Find out what the ECA survey on drug shortage problems brought to light.

What is the FDA´s current thinking with regard to Modern Qualification and Validation? You will find out in a recent lecture from FDA Director Grace McNally.

The API manufacture Zhuhai United Laboratories Co. Ltd. received a Warning Letter from the FDA in June 2018. The FDA criticized that the OOS results of assay determinations haven't been adequately investigated. According to the FDA, the sole use of outlier tests is not appropriate. Read more about FDA's Warning Letter to Zhuhai United Laboratories.