Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.
The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules. Read more about impact of the new EU Data Protection Regulations on clinical trial and pharmacovigilance activities.
Procedures for the analysis of GMP-liable products must be validated. Read here, what deficiencies involving the validation of analytical methods and the handling of OOS results almost inevitably lead to a Warning Letter.
QRM is becoming more and more appreciated and implemented through guidance like the EU-GMP Guidelines and ICH Q8 - Q12. And Quality Risk Management is much more than merely FMEA.
The EU GMP inspectorates inspected more drug manufacturing facilities in 2017. Also, according to the European Medicines Agency (EMA) states in their Annual Report 2017 there are more inspections performed now in the EU as well.
The Chinese API manufacturer Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. received an FDA warning letter in April 2018. During the FDA inspection, the deletion of electronic data of HPLC and GC analyses and the mulfunctioning of the Audit Trail of the laboratory instruments were particularly criticised.
In a securPharm press release, it is pointed out that the new protection system for pharmaceuticals will be launched on 9 February 2019. It is strongly recommended to join soon, since it may be a close call for individual manufacturers otherwise. Find out more about the securPharm press release.
To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.
The final GDP Guidance on Interpretation and Implementation has been published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group of the Chartered Quality Institute.
The minimum requirements for a robust production process are suitable facilities and equipment. Read here about what FDA inspectors identified as root causes for impurities and quality variations in the production of active pharmaceutical ingredients (APIs).