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Products & Services Quality, Compliance and Regulatory Assuring Quality Programs

Benchmarking BioPharma Quality and CAPA Processes: Defining CAPA Benchmarks & Effectiveness Metrics

ID: 5377


Features:

9 Info Graphics

16 Data Graphics

100+ Metrics


Pages/Slides: 35


Published: 2015


Delivery Format: Online PDF Document


 

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Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Benchmarking BioPharma Quality and CAPA Processes: Defining CAPA Benchmarks & Effectiveness Metrics"


STUDY OVERVIEW

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

KEY TOPICS


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.

METHODOLOGY

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.

Industries Profiled:
Biotech; Pharmaceutical; Biopharmaceutical; Manufacturing; Health Care; Medical Device


Companies Profiled:
Amgen; AstraZeneca; Baxalta; Biogen; Douglas Pharmaceuticals; Eisai; Genzyme; GlaxoSmithKline ; ohm Laboratories; RIEMSER Pharma; Roche; UCB Pharma; United Therapeutics; Valeant


If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.