Role of quality control in validation of biopharmaceutical processes: case example of clean-in-place (CIP) procedure for a bioreactor.
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.
Geigert
J
J
Immunex Manufacturing Corporation, Bothell, Washington.
Klinke
R
R
Carter
K
K
Vahratian
A
A
D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000295:instrumentation* / Q000592:standards*; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D005062:European Union; D011786:Quality Control; D011994:Recombinant Proteins / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
D011994:Recombinant Proteins