With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
In the last weeks there were stories about the UK remaining in the EMA even after Brexit. Would this be possible?
After an FDA inspection with relevant results, the FDA usually expects a response within 15 days. What happens, however, if there is no response to the FDA inspection results?
In the EU database for Non-Compliance Reports of European inspections, there is a new entry for the inspection of a pharmaceutical manufacturer in India from November 2017. Main focus of the findings: cross contamination.
The revised versions of two Ph. Eur. general packaging chapters have been published for comment in Pharmeuropa. Read more about 3.2.8. Sterile single-use plastic syringes and 3.2.6. Sets for the transfusion of blood and blood components.
The final release of drug products without the documented prove of compliance with the specifications is a criterion for exclusion, and not just during an FDA inspection. Find out, what other GMP violations regarding the manufacturing and testing FDA inspectors found during an inspection.
In December 2017, the FDA published a new draft guideline for homeopathic products. There is to be a more stringent and risk-based approach by which all products are to be recorded. Find out more about the new FDA requirements for homeopathic products.
On 09 March, 2018, the British supervisory agency MHRA published the final version of its guideline on data integrity which has been available as a draft since July 2016. Find out more on a first analysis of the new document "GXP Data Integrity Guidance and Definitions" .
Drug manufacturer Shanghai Weierya Daily Chemicals in China received an FDA Warning Letter in February 2018. During the inspection, the inadequate sampling when testing active pharmaceutical ingredients and excipients was criticised. Read more about the recent Shanghai Weierya FDA warning letter.
With the Annex 15 revision, the issue of process validation became significantly more complicated. What is an authority's view on the topic of process validation?