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No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
Q. I work in my company’s quality department. What are some best practices for handling process or product changes?
A. In December 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published a recommendation, ‘How to Evaluate/Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management’ (1) and a Concept Note on this Recommendation document (2). This action highlights two critical aspects, namely the importance of change management within the realm of quality and the necessity to apply a risk-based approach.
Nothing stands still; therefore, change is inevitable. Though the PIC/S document covers all relevant steps in the change management process-from change proposal, change assessment, change planning and implementation, through to change review and effectiveness checks-it does not detail categories of change. It merely states, ‘Change categorizations are appropriate and based on the level of risk’ (1).
In practice, the following are three typical categories of change:
Looking at these scenarios, one finds that the starting point can differ (either a change request or a deviation). The end point may also differ; one may end up in a new state (permanent change) or back where it all started from (temporary change). The pathways for these change categories are shown in the flow chart (Figure 1). This flow chart needs to be amended as necessary, to reflect the specific processes and procedures within each company. Just make sure, you comply with all the relevant requirements in the regulations, as summarized in the PIC/S document.
1. PIC/S, “Recommendation, How to Evaluate/Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management,” Nov. 28, 2019.
2. PIC/S, “Concept Note on a Document prepared by the PIC/S QRM Expert Circle on ‘How to Evaluate/Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management’,” Oct. 7, 2019.
Vol. 33, No. 3
When referring to this article, please cite it as S. Schmitt, "Embracing Change Management," BioPharm International 33 (3) 2020.