BioPhorum ‘CPV’ collaboration tackles regulator guidance
Biophorum Operations Group (BioPhorum) has today published a Continued Process Verification (CPV) Case Study to help members of the biopharmaceutical industry implement high quality, consistent CPV plans in response to Stage 3 guidance from the FDA.
The one hundred page case study, written by subject matter experts from many of the world’s major biotech manufacturers, describes the thought processes behind the creation of a CPV Plan. The Case Study contains a model plan, based on a generic monoclonal antibody (mAb) production process, making it clear how critical process parameters are identified, analyzed and reported upon, for every step in the process.
The paper entitled; “Continued Process Verification: An Industry Position Paper with Example Plan”, can be accessed on this website CLICK HERE to register for your free download. The authors, representing many companies in the industry, welcome comments on the paper and these can be sent using the email address: firstname.lastname@example.org.