Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Health Care
AstraZeneca; Sanofi-Aventis (formerly Aventis); Bayer; Eli Lilly; GlaxoSmithKline; Pfizer; Pharmacia (now Pfizer)
As much as 25% of the cost of bringing a pharmaceutical product to market come from manufacturing expenses, according to conservative estimates. A mission-critical component of manufacturing organizations is the quality control (QC) laboratory, which makes certain raw materials, in-process components and finished health-care products meet strict specifications designed to ensure their safety and efficacy for public consumption.
Quality control is a mission-critical component of pharmaceutical manufacturing. The Food & Drug Administration (FDA) strictly regulates hundreds of aspects of drug manufacturing. During the manufacturing process, companies take samples of their products in raw material form, in-process form, and finished product form. These samples are then sent to the quality control laboratories for a series of tests to ensure their safety and efficacy.
This Best Practices Benchmarking® Report examines productivity and quality issues in a highly-regarded group of pharmaceutical companies' quality control laboratories. Best Practices LLC analysts analyzed various issues related to QC lab productivity, including levels of rework and their root causes, the productivity and quality metrics labs use to assess performance, laboratory staffing levels and demographics (including education breakdowns and management-to-analyst ratios), technologies and tactics labs employ to speed up workflow, and communication techniques used to manage schedules and ensure internal clients' needs are met.
By studying other organizations’ best practices in manufacturing quality control, your company can better understand how to organize its QC labs, allocate staffing resources, create a corporate culture driven by attentiveness to product quality, and gain recognition for QC innovation and leadership.
Metrics Included in the Study
Performance metrics enable executives to perform gap analyses and identify areas needing improvement. Metrics are an important complement to the qualitative best practices included in this study report. Best Practices LLC analysts collected and analyzed the following key metrics for QC labs at each of the companies benchmarked in the study:
- How many products are supported by benchmarked labs
- How many different methods are employed in the labs
- How many tests (aka assays) are conducted per year
- How many reworks (aka retests) are conducted per year
- How many personnel are employed at each lab (categorized by full-time, part-time and contractor)
- Management-to-analyst/technician ratios for each lab
- Each lab's approximate ADRFT (assays done right first time, aka first-pass yield) yield
- Percentage of total testing costs consumed by rework
- Percentage of rework caused by a variety of root cause factors