How does the quality program ensure that appropriate monitoring systems are in place?
Under § 1271.160(b)(5), your quality program must establish and maintain appropriate monitoring systems as necessary to comply with requirements in part 1271, subpart D. For example, you might develop systems within the facility for environmental control (§ 1271.195(a)) (e.g., systems to monitor temperature and humidity), environmental monitoring (1271.195(c)) (e.g., viable particulate monitoring in a clean room), and storage (§§ 1271.260) (e.g., systems that monitor the temperature of HCT/P storage units and alarm when out of range). • When HCT/P deviations occur, what is the role of the quality program? Under § 1271.160(b)(6), the quality program must investigate and document HCT/P deviations and trends of HCT/P deviations relating to core CGTP requirements and make reports if required under § 1271.350(b) or other applicable regulations. Each investigation must include a review and evaluation of the HCT/P deviation, the efforts made to determine the cause, and the implementation of c
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- How does the quality program ensure that appropriate monitoring systems are in place?
