Biotech; Pharmaceutical; Biopharmaceutical; Manufacturing; Health Care; Medical Device
Amgen; Baxalta; AstraZeneca; Douglas Pharmaceuticals; Biogen; ohm Laboratories; Eisai; RIEMSER Pharma; Genzyme; GlaxoSmithKline ; Roche; United Therapeutics; UCB Pharma; Valeant
Table of Contents
Executive Summary Pgs. 3-6
Research Overview Pg. 4
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
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