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Products & Services Quality, Compliance and Regulatory Assuring Quality Programs

Benchmarking Quality in the Biopharmaceutical & Medical Device Sector

ID: POP-287


18 Info Graphics

77 Data Graphics

670+ Metrics

Pages: 121

Published: Pre-2019

Delivery Format: Shipped


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Pharmaceutical and medical device companies allocate a considerable amount of resources to ensure their products meet quality standards at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market support. Consequently, Quality leaders face a balancing act between managing costs; ensuring product quality and compliance; and adding value for patients and health care providers.

Best Practices, LLC undertook benchmarking research to probe
how Quality organizations can move beyond simply ensuring product safety and compliance and add enterprise value. In particular, this report provides benchmarks around integrating quality into the organization’s strategic focus and priorities; structure of Quality groups; use of digital technology; managing quality for GLP, GCP, GMP and pharmacovigilance. It also provides benchmarks around Quality staffing and spend levels; supplier management; audit and risk evaluation; CAPA; risk management and outsourcing.

Industries Profiled:
Manufacturing; Medical Device; Health Care; Pharmaceutical; Diagnostic; Biotech; Consulting; Consumer Products; Biopharmaceutical; Clinical Research; Laboratories

Companies Profiled:
3M Company; Abbott; Abbvie; Amgen; Astellas; Baxter; Beckman Coulter; Biogen; Boston Scientific; Daiichi Sankyo; DePuy Synthes; GN Hearing; GlaxoSmithKline ; Idera Pharmaceuticals; Medtronic; Neopharm; NewLink Genetics; Novartis; Sanofi; Seracare; Tesaro; Takeda Pharmaceuticals; UCB Pharma

Study Snapshot

Best Practices, LLC engaged 23 Quality leaders from 23 pharma and medical device companies through a benchmarking survey. Qualitative data was collected via deep-dive interviews with Quality leadership teams. This report includes segmented data for pharma and medical device companies.

Key Findings

  • Medical device companies are nearly twice as likely as pharma companies to rank quality integration across GxPs as a “very important” priority.
  • Technology is adding value to diverse quality functions including CAPAs, complaint management, non-conforming events, vendor management, training & audit.
  • Complaint patterns and on-time delivery considered most effective to determine risk of distribution.

Table of Contents

I.Executive Summary: Insights, Opportunities & Analysispgs. 3-6
Universe of Learning: Benchmark Classpg. 4
Study Structure & Designpg. 5
Project Summary Mappg. 6
II.Strategic View on Quality: Adding Valuepgs. 7-28
Quality Group’s Focus & Prioritiespgs. 9-12
Adding Value and Balancing Riskpgs. 13-19
Quality Dashboardpgs. 20-24
Learning from Med Devicespgs. 25-28
III.Quality Integration Excellence across Enterprise pgs. 29-57
Quality Structure & Global Managementpgs. 31-34
Digital Technology & Qualitypgs. 35-39
Quality Management in GLP/GCPpgs. 40-48
Quality Management in GMP & Logisticspgs. 49-53
Quality Management in Pharmacovigilancepgs. 54-57
IV.Optimizing Staffing & Investment Levelspgs. 58-77
Quality Staffingpgs. 61-68
Quality Spendpgs. 69-77
V.Managing Riskspgs. 78-96
Supplier Quality & Supply Chainpgs. 80-84
Audit & Risk Evaluationpgs. 85-88
Corrective and Preventive Actionspgs. 89-92
Risk Management Metricspgs. 93-96
VI.Outsourcing Excellence and Agile Qualitypgs. 97-113
Building Agile Quality Organizationpgs. 98-104
Outsourcing Excellencepgs. 105-113
VII.Demographicspgs. 114-120

    List of Charts & Exhibits

    I. Strategic View: How Quality Can Add Value

    Understanding Quality Group’s Strategic Focus & Priorities
    • Indicate the frequency with which your company conducts various practices associated with its Quality Governance
    • Rate the Quality function’s performance in each of the following areas where Quality might contribute to your company’s overall strategy
    • How important are the following objectives for your Quality organization?

    Adding Value and Balancing Risk Through Quality
    • Rate your Quality function’s maturity level in each of the following areas where Quality might contribute to your company’s overall strategy
    • Maturity topography map: Quality maturity level by area
    • Rate the importance of each Risk Management dimension to your overall Quality strategy
    • How does Quality evolve from compliance to adding value?
    • Estimate what pricing premium (if any) do your major products win over your competitors due to perceived quality reputation

    Quality Dashboard for Executive Communication
    • Frequency of Quality communication
    • Rate the effectiveness of the following Quality metrics that you use to communicate and summarize your Quality performance at the organizational dashboard level
    • Key Quality indicators (KQIs) in corporate dashboards - Stratified by KQIs in pre-clinical, clinical, manufacturing, distribution, GxPs, supplier, CAPA, customer, EBITDA, patient value and new product development

    What Can Biopharmaceuticals Learn from Medical Device Companies
    • Percentage of companies that consider establishing holistic / integrated Quality approach across all GxPs “very important”
    • Percentage of companies rating the following approaches “highly effective” to ensure agile Quality – Simplification of Quality design and systems and Uniform Quality technology system across all operations
    • Rate the effectiveness of the following Quality audit factors in assessing and preventing various forms of GLP/GCP/GMP or PV product safety risks

    II. Quality Integration Excellence across Enterprise

    Quality Structure and Global Management
    • Maturity of global Quality system
    • How is your company’s Quality function organized?
    • Indicate the integration approach your Quality organization takes in serving your company
    • Effectiveness of various listed Quality approaches to ensure global operations are safe and effective across all countries where participants do business

    Digital Technology & Quality Improvement Catalysts
    • Benefits produced by digital-enablement technologies
    • What uses of digital technology are most promising for enhancing quality in each of the listed areas?
    • Evaluate the effectiveness of digital technologies and software tools used for analyzing, visualizing, validating, managing and reporting
    • What approaches to Quality data visualization seem to work best for spotting issue patterns and taking preventive or corrective actions?
    • Indicate the scope and breadth of your clinical trials and development programs which Quality must help manage and support
    • Revenue per clinical trial and average number of patients per clinical trial
    • Total number of pre-clinical research sites and geographic distribution of pre-clinical research studies and activities
    • Effectiveness of listed tools and approaches in effectively managing GCP/GLP Quality Assurance function
    • Do you perform remote audits for GLP/GCP? If yes, how do you decide if an audit can be conducted remotely?
    • Effectiveness of Quality practices that may be applied in the clinical research and development
    • For the past 12 months, estimate the number of critical/major audit findings in clinical trials and number of deviations to research protocol
    • Estimate the percentage of clinical Quality staff’s time focused on clinical development Quality Assurance activities, bioanalytical activities, non-clinical development Quality Assurance activities

    Quality Management in GMP and Logistics
    • Quality indicators to inform manufacturing, distribution & CAPA/NCE performance
    • Number of Quality GMP FTEs per $100M in revenue
    • GMP staffing density - Number of GMP FTEs / Total Quality FTEs
    • Most critical measures for manufacturing quality management
    • Critical measures for distribution and logistics Quality management

    Quality Management in Pharmacovigilance (PV)
    • Pharmacovigilance staffing benchmarks - Number of Quality PVQA FTEs per $100M in revenue
    • Highly effective factors in assessing and preventing various forms of pharmacovigilance risk
    • Role played by PVQA in listed audit activities

    III. Quality Staffing & Investment
    • Factors that drive QA resource levels up or down

    Quality Staffing & Resource Benchmarks
    • Average Quality staffing ratio - Quality FTEs to Total FTEs
    • Total Quality FTEs (internal + outsourced)
    • Quality staffing density - Total Quality FTEs / Total FTEs
    • Quality staffing allocation - Quality FTE by Area / Total Quality FTE
    • Quality span of control: Estimate the average number of direct reports at each supervisory level in your Quality organization
    • How has the total number of Quality FTEs changed over the past 3 years and what do you anticipate for the next three years?

    Quality Investment and Resources
    • Average Quality spend ratio by segment - Quality spend to revenue
    • Quality spend per $100M in revenue
    • Quality as a percentage of revenue
    • Quality spend allocations across functions
    • Mapping Quality staffing and Quality spend zones
    • Quality spend per Quality FTE
    • Average revenue supported by a Quality FTE
    • Examining inclusion and exclusion charges across Quality budgets

    IV. Quality Risk Management Benchmarks & Best Practices

    Managing Supplier Quality & Supply Chain Risk
    • Key drivers of Quality effectiveness across pre-clinical, development and supplier Quality functions
    • Highly effective metrics in measuring supplier risk
    • Most effective practices for developing strong working relationships with vendors and outsource partners
    • Most valuable tools to evaluate vendor performance

    Audit & Risk Evaluation Management
    • Effectiveness of the Quality audit factors in assessing and preventing various forms of GLP/GCP/GMP or PV product safety risks
    • Importance of listed audit activity for assessing GLP/GCP risk and ensuring safety
    • When a critical audit finding is identified, do you routinely re-audit the area in future? If yes, how soon after the closure do you re-audit?

    Corrective and Preventive Actions
    • Number of open CAPAs and NCEs
    • Highly important elements in Root Cause analysis
    • Effective approaches employed to enable Quality staff in effective Root Cause analysis

    Risk Management Metrics
    • Relative effectiveness of KQIs for assessing and communicating risk performance in a corporate risk dashboard
    • Effective metrics to determine production risk to the Quality function
    • Effective metrics to determine distribution risk to the Quality function

    V. Outsourcing Excellence and Agile Quality

    Building Agile Quality Organization
    • Is agility among top priorities on Quality organization’s agenda?
    • Top three challenges that are preventing Quality organization from becoming more agile
    • How do you assess the presence of the listed attributes that support agile Quality organization?
    • Quality agility health check
    • Effectiveness of listed approaches in developing Quality systems that respond rapidly to problems, issues and opportunities
    • Drivers of the location of Quality centers
    • Does your company employ a systematic or mature approach to isolate the most "critical to quality parameters” that spotlight select factors most significantly driving quality performance the listed systems?

    Quality Outsourcing Excellence
    • What are your insourcing (company employees) / outsourcing (vendors) mix for the listed categories?
    • Number of company-run and outsourced discrete manufacturing plants
    • Number of company-run and contractor-run (CMO) discrete manufacturing plants that are based in the listed regions
    • Benefits / risks of working with product and service providers
    • Outsourced Quality FTEs
    • Quality outsourced level - Number of Outsourced Quality FTEs / Total Quality FTEs
    • Impact of FTE outsourcing on Quality spend
    • FTE outsourcing vs Quality FTE ratio