5 Ways Pharma and Medical Device Manufacturers Can Use Technology to Promote Quality and Compliance

Eric Weisbrod
By Eric Weisbrod | April 14, 2015
Vice President, Product Management

Because life sciences products are often ingested or implanted in the body, it is critical for pharmaceutical and medical device companies to adhere to stringent safety and regulatory compliance standards. Using advanced technologies, manufacturers can employ a holistic approach to quality and ensure product safety. Below are five ways pharmaceutical and medical device manufacturers can use enterprise quality systems, Manufacturing Intelligence platforms and automated device integration together to decrease recalls, speed time-to-market, reduce waste and increase profitability.

  1. Be Proactive, Not Reactive: Life sciences manufacturers traditionally focus their efforts on developing response plans in the event of a recall, rather than executing preventative measures. With a quality culture and a Manufacturing Intelligence platform, manufacturers can collect and analyze disparate data from across the supply chain and gain greater insight into manufacturing processes. Operators can then make adjustments based on this insight to improve product quality, helping to prevent recalls and plan for risk mitigation.
  2. Use Acceptance Sampling: Inspection is an important step to evaluate the quality and safety of life sciences products. However, 100-percent inspection would be an exhaustive expenditure of people, time and resources. Instead, manufacturers can deploy 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) — to streamline inspections during high-volume production, while maintaining quality.
  3. Eliminate Paperwork: Manually recording data during product development and manufacturing leads to a tremendous amount of paperwork. By automating manufacturing processes and data input into a single, centralized repository, the data become both easily accessible and understandable for all personnel. Inputting data into quality systems eliminates cumbersome binders and filing cabinets previously required to house papers.
  4. Simplify Compliance and Validation: Complying with laws set by the Federal Drug Administration (FDA 21 CFR Part 11 and Part 820), the International Conference on Harmonisation 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) can be challenging and may even 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 streamline compliance.
  5. Reduce Scrap and Yields: High-volume production helps companies quickly get products on the shelf, but often results in high levels of scrap. Many manufacturers note scrap and yield but few take steps to reduce, much less track, these numbers. Manufacturing Intelligence software powered by SPC monitors scrap and can trace it back to its source. Adjusting processes or packaging based on this analysis can decrease waste, lower costs and ultimately increase profitability.   

Together, enterprise quality systems, Manufacturing Intelligence platforms and automation help pharmaceutical and medical device manufacturers continue to deliver life-altering, and often life-saving, solutions. These technologies promote product safety and quality, speed time to market and streamline regulatory compliance procedures – benefitting both the life sciences manufacturer and the consumer.


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