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» Products & Services » » Quality, Compliance and Regulatory » Assuring Quality Programs

Benchmarking BioPharma Quality and CAPA Processes

ID: POP-261


Features:

21 Info Graphics

35 Data Graphics

400+ Metrics

4 Narratives

12 Best Practices


Pages: 73


Published: 2015


Delivery Format: Shipped


 

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Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

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
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
A well-defined CAPA system is essential for any biopharmaceutical company to drive quality improvements across the organization. Hence, it is imperative for Quality groups to measure the effectiveness of their CAPA processes to enhance the productivity of their quality function.


Best Practices, LLC recently undertook a study to assist companies in achieving top-tier performance in three important areas critical to Quality: CAPA Process Management, CAPA Performance Benchmarks and Quality Resource Management. This study will serve as a benchmark for Quality leaders in building a strong CAPA system and thereby developing a robust quality function, within tight budgets.


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


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


Study Snapshot

This benchmarking study engaged 14 executives from leading biopharmaceutical organizations. Data
is charted throughout this report for the “Total Benchmark Class” (TBC) as well as for the “Large Company Segment” (LCS), which includes 9 companies with biopharmaceutical revenues above $5B.

Key Findings

Quality Spend & Staff Levels and Trends: Complexity factors, regulatory restrictions and process management factors are the top areas that effect Quality resource levels. To ensure lower costs, companies must manage the factors that they can have high control on.

Quality Spend Mix:  Benchmarked companies have a critical improvement area for allocating higher percent of their quality budget to prevention and this change may decrease budget allocated to appraisal activities and external failures.
Quality Reporting and Ownership:  It’s important for companies to align quality ownership with quality budget management.  As the functions that have the ownership of quality activities obtain more financial resources and responsibilities, budget allocation to several activities will be more effective.

Table of Contents

Executive Summary    Pgs. 3-6
Research Overview   Pg. 4
Participating Companies  Pg. 5
Definitions and Abbreviations   Pg. 6
Key Findings and Insights  Pgs. 7-10
CAPA Benchmarks and Defining CAPA   Pgs. 11-18
CAPA Effectiveness Metrics  Pgs. 19-24
FDA Questions, Inspections and Observations  Pgs. 25-28
Best Practices for Building a Strong CAPA System  Pgs. 29-30
Quality Spend Levels and Trends  Pgs. 31-36
Quality Staff Levels   Pgs. 37-41
Quality Spend Mix   Pgs. 42-48
Quality Reporting and Ownership   Pgs. 49-53
Quality Spend Drivers  Pgs. 54-59
Outsourcing Quality   Pgs. 60-64
Best Practices for a Robust Quality Function  Pgs. 65-66
Demographics  Pgs.  67-71
About Best Practices, LLC    Pg.  72-73

    List of Charts & Exhibits

    Number of Lots, CAPAs and Nonconforming events (NCEs) – TBC
    Open CAPAs per $100M Revenue
    Start and End Point of a CAPA
    Defining Rediscovered CAPAs
    CAPA Cycle Times: Please indicate the average time in days it takes for your company to fulfill the following actions.
    CAPA Effectiveness Metrics
    Success Rate Averages: How many lots did you manufacture and what was the percentage without CAPA in 2014?
    CAPA Percentages: Please estimate the percentage of your annual CAPAs that are considered preventive (% no. of CA / no. of PA), as well as the target annual percentage for preventive CAPAs in 2014.
    FDA Questions: Please estimate the annual number of questions that were raised by FDA on your CAPA system in 2014.
    CAPA Related Observations: Please give specific information on the following in your organization for the year of 2014.
    Resource Allocation on Quality Channels
    Resource Allocation Trends
    Total Quality Spend: What was the total spend of your Quality function in 2014 for biopharmaceutical products and related services?
    Total Quality FTEs: Within your biopharmaceutical and related services business, please provide the total number of FTEs in your Quality Function at the end of 2014.
    Quality Spend Inclusions
    Spend Allocation Averages
    Average Spend Allocation Mix
    Pathway to choose the right CMO
    Cost of Quality (CoQ) Reporting Categories
    CoQ Budget Management & Ownership
    Factors Increasing Quality Spend – Complexity, Process Management and Regulatory Factors.
    Managing Quality Labor Costs
    Managing Quality Labor Costs Across Global Markets- IN-HOUSE ACTIVITIES
    Best Practices for a Robust Quality Function