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Quality Compliance

Clinical and manufacturing departments tend to view quality and compliance from different perspectives because they are each focussed on different sets of compliance requirements (or perhaps the industry has become conditioned to seeing them as distinct on a perfunctory level). However, both groups can streamline compliance and increase effectiveness by applying many of the same quality practices to their compliance efforts. The core ideologies that form the basis of quality best practices are universal principles that apply not only to Good Manufacturing Practice (GMP) but to Good Clinical Practice (GCP) as well.

Intersections in Compliance Requirements

Clinical and manufacturing compliance efforts overlap in several comparable areas:

Deviations
Just as deviations in manufacturing are indicative of poor product quality, the lack of protocol adherence and inconsistencies in protocol implementation are signifiers of quality deficiencies in clinical trials. Since the study protocol is the single most important document in a clinical trial, adherence to the protocol is essential if quality is to be maintained. Correspondingly, strict observance of production standard operating procedures (SOPs) in manufacturing is critical to effective quality management. Parallel to an effective quality management system’s (QMS) criticality to deviation management in manufacturing, a systematised approach to clinical quality that emphasises clinical quality management principles can refine the focus on events that occur across studies and product lines and help manage actiontaking once a deviation issue has been identified. Always keep in mind that many deviation management principles can be applied in both manufacturing and clinical scenarios, such as identifying the source of an issue, identifying any areas that may be impacted, and using universal problemsolving techniques to conduct root cause analyses (ie, fishbone diagrams, the ‘5 Whys’ technique, etc).

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Patricia Santos-Serrao, MasterControl’s Director of Clinical and Regulatory Solutions, started her life sciences career in 1994 with Schering-Plough and later joined Boehringer Ingelheim Pharmaceutical. Within both organisations, Patricia took a leading role in transitioning business processes, document management, and submission compilation from paper to electronic systems. She is a member of Regulatory Affairs Professional Society (RAPS) and earned her Regulatory Affairs Certification from RAPS and the Regulatory Affairs Certification Board. Patricia is a member of the Drug Information Association (DIA) and a member of the DIA-sponsored Trial Master File Reference Model working group.
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Patricia Santos-Serrao
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