Regulatory Compliance

InTouch
In March 2017, ISPE submitted an extensive and detailed response 1 to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics Data," 2 the associated Federal Register Notice, 3 and webinar. 4 These comments reflected ISPE's conclusion that the program, as...
Technical
India is a worldwide leader in drug manufacturing, producing 10% of global pharmaceuticals, with 2016–2017 exports valued at $16.4 billion. 1 Indian generic manufacturers generate 20% of all global exports and more than 80% of antiretroviral drugs in the developing world. 7 India's pharmaceutical...
Technical
We propose a method for demonstrating content uniformity in the context of variables sampling and relate this to the acceptance criteria and probability of passing the USP CU test. We demonstrate that a variable sampling plan with 99.4% coverage between 83.5% and 116.5% of label content is...
Technical
This paper was written by members of the BioPhorum Operations Group CPV and Informatics team and widely reviewed across the BPOG collaboration. As such, it represents the current consensus view of process verification subject matter experts in the biopharmaceutical industry, but does not represent...