TY - JOUR 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 SP - 236 LP - 240 VL - 48 IS - 5 AU - John Geigert AU - Ralph Klinke AU - Kerri Carter AU - Annette Vahratian Y1 - 1994/09/01 UR - http://journal.pda.org/content/48/5/236.abstract N2 - 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. ER -