Articles by Anita Grochulski - BioPharm International

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Articles by Anita Grochulski

Expediting the Technical Transfer of Biopharmaceutical Products

Proper infrastructure ensures equivalent analytical results at all laboratories for a successful simultaneous commercial release from various sites.
Sep 2, 2006

Established, fully validated methodology and SOPs are required prior to initiation of any training activities.

The Laboratory Control System: Fulfilling cGMP Requirements

A proactive approach is needed to ensure all elements of the laboratory system are in compliance.
Sep 2, 2006

Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.

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