BioPharm March eBook - Outsourcing Resources

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Page 10 of 34 March 2018 BioPharm International eBook 11 Outsourcing Resources Quality Quality Oversight During Sterile Filling Operations The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective. PHILIP HOERSCH T he concept of quality oversight is increas- i n g l y u s e d i n t h e c o n t e x t o f G M P - c o m p l i a n t p r o d u c t i o n o p e r a t i o n s . I t represents the quality understanding of a pha r maceut ica l ma nu fac t u rer as wel l as the involvement and responsibility of management. In t his context, it includes t he qua lit y systems implemented to enable compliance with internal and regulatory specifications and regulations. An important aspect of quality oversight is the internal control function. Regular internal checks preceding reg ulatory inspections can significantly increase the quality in the production process. The author shows how an operative quality over- sight function can be implemented in the area of aseptic f illing using Vetter's approach as a case study example. What needs to be considered during its introduction? What challenges arise? How can companies benefit from this function to meet both regulatory requirements and to create added value w ithin the control and oversight f unction? T he author also explains how quality oversight can be integrated into an existing quality management sys- PHILIP HOERSCH, PHD, is director, Quality Assurance—Validation/Risk Management/Trending, Vetter Pharma-Fertigung GmbH & Co. KG. TRAIMAK/SHUTTERSTOCK.COM

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