RT Journal Article
SR Electronic
T1 Role of Quality Control in Validation of Biopharmaceutical Processes: Case Example of Clean-in-Place (CIP) Procedure for a Bioreactor
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 236
OP 240
VO 48
IS 5
A1 Geigert, John
A1 Klinke, Ralph
A1 Carter, Kerri
A1 Vahratian, Annette
YR 1994
UL http://journal.pda.org/content/48/5/236.abstract
AB If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoids a situation where the test results either invalidate or inadequately support the validation plan. A case example is presented for an approach used to validate Clean-in-Place (CIP) procedures for 1600 L bioreactors which are operated on a campaign basis for multi-biopharmaceutical synthesis.