www.biopharminternational.com 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
