Study details best practice in QC
pharma firms manage their quality control to reduce manufacuring
costs and production time.
Focusing on quality initiatives helps top-performing pharmaceutical labs reduce manufacturing costs and minimise production time, according to a new study from pharmaceutical research firm Best Practices.
As much as 25 per cent of the cost of bringing a pharmaceutical product to market come from manufacturing expenses, according to estimates. A mission-critical component of manufacturing organisations is the quality control (QC) laboratory, which ensures raw materials, in-process components and finished health care products meet strict specifications designed to ensure their safety and efficacy for public consumption.
The study is based on a survey of a number of 'benchmark' companies, including AstraZeneca, Aventis, Bayer, Eli Lilly, GlaxoSmithKline, Pfizer and Pharmacia. It analyses their approaches to 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 the communication techniques used to manage schedules and ensure internal clients' needs are met.
Among the findings of the survey are that several benchmarked companies tie performance indicators to employee compensation. These companies boast extremely high first-pass yields of over 99 per cent. Benchmark surveys and best practice interviews reveal most QC laboratories already track a variety of productivity and quality indicators, including an assays done right first time yield (ADRFT), testing cycle times, analyst/chemist productivity and rework. However, only a few labs directly tie performance measures to employee compensation, according to the report.
In addition, one top-performing company employs six floor supervisors who split their time between management responsibilities (40 per cent) and actual bench work (60 per cent), improving both the throughput and the quality of work performed by analysts.
Meanwhile, pharmaceutical laboratories are becoming increasingly reliant on technology to speed the testing process, reduce errors and improve overall quality, according to Best Practices. Advances in Laboratory Information System software have increased options for tracking samples through the lab process and the top players are investing in new software packages, as well as databases, barcodes, automation and robotics.
"Quality control labs are a mission-critical component of drug manufacturing," said Keith Symmers, vice president of Best. "This study shows quality executives how to save time and money in their quality control testing processes."
For more information about this report, contact Susan Silverstein.