PT  - JOURNAL ARTICLE
AU  - Geigert, John
AU  - Klinke, Ralph
AU  - Carter, Kerri
AU  - Vahratian, Annette
TI  - Role of Quality Control in Validation of Biopharmaceutical Processes: Case Example of Clean-in-Place (CIP) Procedure for a Bioreactor
DP  - 1994 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 236--240
VI  - 48
IP  - 5
4099  - http://journal.pda.org/content/48/5/236.short
4100  - http://journal.pda.org/content/48/5/236.full
SO  - PDA J Pharm Sci Technol1994 Sep 01; 48
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.