Want to avoid quality and safety issues in your regulated environments?

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The challenge of managing regulated environments should not distract from the mission of developing breakthrough products in life sciences and related industries. Compliance is a mission-critical function; however, it does not need to be treated as a core competency that must be performed entirely in-house. In fact, life sciences companies are learning that by turning over the process to expert third parties, they can not only increase their focus on research and development, but also reduce operational costs and fill any gaps in compliance.

To take a deeper dive in to managing regulated evironments, visit: http://bit.ly/O0B4Gf

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Want to avoid quality and safety issues in your regulated environments?

  1. 1. Want to avoid quality and safety issues in your regulated environments? Find the right partner to manage those spaces.
  2. 2. Regulated Environments The challenge of managing regulated environments should not distract from the mission of developing breakthrough products in life sciences and related industries.
  3. 3. Compliance is mission critical Turning over the process to third party experts can increase your focus on research and development, reduce operational costs, and fill any gaps in compliance. But does not need to be performed entirely in-house
  4. 4. Compliance can be complicated • Pharma companies must follow an average of 1,250 Standard Operating Procedures (SOPs) required by the Food and Drug Administration in the U.S. and by the World Health Organization and other governing bodies internationally • In addition to good manufacturing processes, firms are often subject to SOPs regarding laboratory practices (GLP), clinical practices (GCP) and other categories, collectively known as cGxP • Compliance requires an average of 15,000 hours of labor per year, spent primarily on training, administration and documentation • Everyone who works onsite—scientists, senior managers, and even third-party workers who clean facilities or maintain and repair equipment—must be qualified under FDA’s guidelines
  5. 5. There are strong repercussions for non-compliance Any breach of compliance can result in a 483 observation from FDA inspectors, which can lead to a Warning Letter that can potentially cost the firm millions of dollars. A mistake can also lead to an actual safety or quality breach that poses an existential threat to the activities performed at that facility.
  6. 6. It’s not just a large company issue The systems and practices for cGxP compliance are scalable to different company size needs. The benefits of using an outside facilities services firm may be the greatest for smaller firms.
  7. 7. The benefits go beyond cost savings Third-party cGxP compliance partners provide the opportunity for newer or smaller life sciences companies to “hit the ground running” with complete systems that need only be adapted to each company’s specific needs. Experienced professionals can be leveraged from other accounts to bring new clients up to speed quickly. Faced with an unfamiliar situation, an outside facilities expert has many expert colleagues and internal resources to tap for advice on cGMP.
  8. 8. COPYRIGHT © JONES LANG LASALLE IP, INC. 2014 Thank you Engage a knowledgeable regulated environments expert George Wittmann: George.Wittmann@am.jll.com Dick Auger: Richard.Auger@am.jll.com Want to learn more about effectively managing regulated environments? Click here to read our full paper.

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