We recently reported that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) had published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography. The agency has now released a slightly modified version of the draft of new General Test <2.00> Chromatography. Comments can be submitted until November 30, 2021.
Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.
In the current Pharmacopeial Forum, PF 47(6), a stimuli article entitled The Case for Apex Vessels was published.
The EDQM has announced in a press release that the harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together Ph. Eur., JP and USP.
The Dosage Forms Expert Committee intends to revise USP General Chapter <711> Dissolution.
Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.
A few but fundamental GMP requirements for pharmaceutical quality control laboratories are a frequent focus of regulatory inspections. During a visit to a U.S. contract laboratory, FDA inspectors found serious deficiencies in these requirements, resulting in a Warning Letter due to inadequate handling of OOS results, lack of electronic system security and data manipulation.
An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.
To support voluntary submissions of medicinal product information for medicinal products supplied in the EU / EEA via parallel importation, or for emergency and compassionate use, new 'Legal basis' values will be made available in the "Article 57 database" (xEVMPD).
The FDA issued a warning letter for not complying with regulations during the clinical investigation of a COVID-19- IMP. In particular, the sponsor failed to submit an investigational new drug application.