In June 2018, the FDA approved the first-ever pharmaceutical derived from the cannabis plant, Epidiolex (cannabidiol, CBD). GW Pharmaceuticals’ lead therapeutic reduces the frequency of…
Month: January 2019
Shoshana Zuboff’s new book is a chilling exposé of the business model that underpins the digital world. Observer tech columnist John Naughton explains the importance…
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive Pharmaceutical products What is…
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products This technical supplement…
This technical supplement has been written to amplify the recommendations given in section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for…
Temperature mapping establishes the temperature distribution within the zone being mapped and it locates hot and cold spots. A temperature mapping exercise is required for any space…
Good manufacturing practice (GMP) regulators in the United States, Canada, European Union, Japan, Australia, and China have sharpened their focus on warehouse storage and distribution practices. Driving this…
This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation…
Important note regarding FDA Aseptic Guidelines: – FDA Aseptic guidelines do not allow averaging at a sampling site! – Each discrete sample must be below the…
A New Reality? “It is not possible to maintain a manufacturing environment that is sterile. In any environment where human operators are present microbial contamination is inevitable.…