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How Pharma and Medical Device Manufacturers Can Streamline Compliance

Five top recommendations for life sciences companies

Published: Tuesday, February 17, 2015 - 17:05

(InfinityQS: Fairfax, VA) -- InfinityQS International Inc., the global authority on real-time quality and manufacturing intelligence, recommends five ways pharmaceutical and medical device manufacturers can use enterprise quality systems, manufacturing intelligence platforms, and automated device integration to decrease recalls, reduce waste, and increase profitability. Together, these technologies speed time to market and streamline regulatory compliance procedures by improving the efficiency of manufacturing processes, using data to understand variability, standardizing facilities after mergers or acquisitions, and better aligning R&D and engineering.

InfinityQS has dedicated more than 25 years to helping manufacturers improve efficiency across operations and offers the following recommendations for the life sciences industry:

1. Be preventative, not just responsive. Because of the sheer speed necessary to take a new pharmaceutical product or medical device from R&D to market, life sciences manufacturers have traditionally focused on production volume and developing comprehensive response plans in the event of a recall. With a quality culture and a manufacturing intelligence platform, engineers, quality professionals, and executives can all analyze data and look at the big picture to better understand the inherent variability in manufacturing processes. Operators can then make adjustments based on this insight to improve product quality, help prevent recalls, and plan for continuous improvement. Cell or suite-based production is ideal for compliance, however, a holistic picture of the data collected in these cells helps drive innovation and risk mitigation.

2. Employ electronic acceptance sampling techniques. Products in the life sciences industry are often ingested or implanted in the human body, making inspection critical. A 100-percent inspection would be expected for both incoming and final inspections, but that demands a lot of people, metrology equipment, time, and paperwork. Instead, use statistical process control (SPC) and acceptance sampling techniques. Lot tolerance percent defective (LTPD), American National Standards Institute (ANSI) Z1.4, ANSI Z1.9, or zero acceptance number sampling (c = 0) are statistically sound and proven methods to reduce inspection frequency while maintaining the highest level of quality.

3. Eliminate paper and manual processes. The amount of paperwork required to support the development and production of a single product can be overwhelming. Inputting data into quality systems eliminates cumbersome binders and filing cabinets, while ensuring data is still easily accessible and understandable. By automating manufacturing processes and data input into a single, centralized repository, manufacturers can also increase accuracy and create definitive traceability for every product, component, and ingredient. Also, extending automation to incoming inspection with device integration will save both time and personnel hours, leading to additional cost savings and efficiencies.

4. Simplify regulatory compliance and validation. The critical nature of pharmaceutical medications and medical devices elicits stringent safety regulations on both products and technology. Complying with laws from the Federal Drug Administration (FDA 21 CFR Part 11 and Part 820), the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q9, ICH Q10), the International Organization for Standardization (ISO 13485), or the European Commission's Directorate General for Enterprise and Industry (GMP Annex 20) is challenging and can cause delays in production. Utilizing a quality system to easily access necessary data will satisfy reporting requirements for each of these organizations. Additionally, software that provides validation assistance will further speed up the process.

5. Track and understand scrap and yields. Life science organizations go into high-volume production soon after products are approved for public distribution. This quickly provides remedies for various medical ailments, but often results in high levels of scrap. Though manufacturers note scrap and yield numbers, many don’t track these numbers over an extended period of time and don’t understand why the numbers are so high. Manufacturing intelligence software powered by SPC monitors scrap and can trace it back to its root cause. Adjusting processes or packaging based on this analysis can decrease the amount of waste, mitigate costs, and ultimately increase profitability.

“Pharmaceutical and medical device manufacturers deliver life-altering and often life-saving solutions for a growing number of malicious diseases, disorders, and physical afflictions,” says Jack Lan, global account executive for InfinityQS. “The use of technology to employ a holistic approach to product quality across the value stream can inevitably help ensure product safety and regulatory compliance, while increasing speed to market and corporate profitability. The result is a win-win situation for everyone, from supplier to consumer.”


About The Author

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InfinityQS is a leading provider of statistical process control (SPC) software and services to a broad array of companies, from multinational giants to smaller, more specialized manufacturers. InfinityQS develops software solutions to help manufacturers monitor, control, and improve the quality of their manufacturing operations across a site, an enterprise, or an entire supply chain, continuing to provide significant returns on their initial investment and increase productivity.