Diverging from conventional practices, the risk- and science-based commissioning and qualification (C&Q) approach involves generating documented evidence to ensure that systems are installed and operate to comply with established specifications. Spearheaded by the engineering team and quality and other process experts, this evidence is generated in accordance with the company’s Good Engineering Practices. The format of these documentation sets is predetermined within C&Q plans, subject to the company’s quality approval procedures.
The C&Q Baseline® Guide provides in-depth insights into implementing risk- and science-based C&Q approaches. To support this, a team of industry experts has crafted examples of C&Q deliverables spanning three distinct types of manufacturing systems: bioreactor unit operation, primary and secondary packaging operation, and utility systems. Although these examples may not universally apply, their aim is to provide examples of the output for these systems to enhance the understanding of the baseline guide approach.
It is important to note that these examples are not intended for direct adoption but rather to facilitate a deeper understanding of the C&Q Baseline® Guide. Therefore, it is recommended to engage with the guide before using these examples.
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Acknowledgments
By Commissioning and Qualification Community of Practice Steering Committee Members
