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Quality, Compliance and Regulatory » Assuring Quality Programs
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In the wake of an increasingly regulated healthcare environment, biopharmaceutical companies are optimizing their Quality function to ensure that their products meet the highest quality standards and regulatory requirements.
A robust Corrective and Preventive Action (CAPA) system will help drive quality improvements and operational excellence in the organization. Thus, Quality leaders must continually assess the effectiveness of their CAPA processes to protect against manufacturing disruptions.
Best Practices, LLC undertook a benchmarking initiative to assist companies in achieving performance excellence in their CAPA processes. In particular, the study provides benchmarks and insights around CAPA process management and effectiveness.
Quality leaders can use this study to compare their CAPA processes and effectiveness measures with the practices at peer organizations.
This study presents two segments on some questions: All Participants and Large Companies
· CAPA Benchmarks and Defining CAPA
· CAPA Effectiveness Metrics
· FDA Questions, Inspections and Observations
· Best Practices for Building a Strong CAPA System
SAMPLE KEY METRICS
· Number of Lots, CAPAs and Nonconforming events (NCEs) processed by benchmark participants on an annual basis
· Number of open CAPAs per $100M Revenue
· Defining the start and end point of a CAPA
· Process for defining rediscovered CAPAs
· Average CAPA cycle time taken to fulfill listed activities
· Metrics used by the benchmark class to measure CAPA effectiveness
· Percentage of annual lots processed without CAPA
· Percentage of annual CAPAs that are considered preventive and the targeted annual percentage for preventive CAPAs
· Annual number of questions raised by the FDA on participants’ CAPA system
· Number of inspections and observations conducted for the year
SAMPLE KEY FINDING
· Volume of Open CAPAs: The way that companies define "start and end points" of CAPA plays a critical role in understanding the CAPA success of the companies. While companies with strict definitions of CAPA end points may have high number of open CAPAs, the companies with loose end point definition may end up having less open CAPAs.
Best Practices, LLC recruited Quality function and CAPA Process executives at 14 biopharmaceutical organizations to share their data and insights in a customized benchmarking study.
Biotech; Pharmaceutical; Biopharmaceutical; Manufacturing; Health Care; Medical Device
Amgen; AstraZeneca; Baxalta; Biogen; Douglas Pharmaceuticals; Eisai; Genzyme; GlaxoSmithKline ; ohm Laboratories; RIEMSER Pharma; Roche; UCB Pharma; United Therapeutics; Valeant