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Considerations for a successful tech transfer of a biologics upstream process

European Pharmaceutical Review

The inevitable shift to external manufacturing sites necessitates a seamless technology transfer process, and should incorporate unique perspectives on local approaches to knowledge transfer, quality, regulatory and all other operational requirements pertaining to the sites locality.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. Additional documents included each month. Additional documents included each month. Corrective actions are taken to fix a defect on hand. All written and updated by GMP experts.

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Data and digital is a force to reckon with when it comes to India

Express Pharma

People may not be dealing with patients, but somebody who is doing case processing of an adverse event, must not look at it only as a document to fill in data. Bengaluru is a very nice sandbox environment, when you run transformation projects like process improvement. We were very particular about the patient angle.