GMP News

On the MHRA Inspectorate blog a new post has just been published emphasizing that according to GCP dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Read more about "Dose Escalation - is it GCP compliant?"

The Pharmaceutical Inspection Co-operation Scheme as international association of pharmaceutical inspectors is currently elaborating a document on data integrity. This document was published for comment on 30 November 2018. Among others, the ECA Foundation has been given the opportunity by the PICS to comment on this third draft by 28 February 2019. Read more about the new draft 3 of PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

Again and again, the question arises as to whether a bracketing approach - i.e. selective skipping of individuals tests - may be used for the qualification of identical pieces of equipment. Can the answer to the question whether or not to skip individual tests be found in Part IV of the EU GMP Guide?

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.