A company in China has created GMP documents only for the purpose of inspection. With serious consequences.
Significant deficiencies in the pharmaceutical quality management system led to a Warning Letter to the American company Akorn. What deviations in media fill and aseptic behavior were detected in the inspected company?
The USPs General ChaptersPackaging and Distribution Expert Committee provided an overview of USPs current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.
During the inspection of a pharmaceutical manufacturer in the USA, the FDA discovered fundamental GMP deficiencies which concern - among other things - cleaning of equipment, cleaning validation, the water system and the stability programme.
Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.
In order to encourage stakeholders to take the opportunity to send comments on the application of AQbD to pharmacopoeial standards, the MHRA provides some Questions and Answers.
The brand new and completely revised and enlarged 2019 edition of the Defect Evaluation List for Rubber Parts has been published.
In both years 2017 and 2018 (period from October 1 to September 30), we reported a noticeably low number of Warning Letters. This seems to go on in 2019.
With the revision of Annex 15 in October 2015, the topic of requalification has become more important. Time intervals for the assessment of the equipment with regard to the qualification status and for the requalification itself should be justified. Criteria for the assessment should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE Baseline No 5 Commissioning & Qualification of June 2019 on the periodic review can be helpful here.