want to avoid quality and safety issues in your regulated environments?
DESCRIPTION
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/O0B4GfTRANSCRIPT
Want to avoid quality and safety issues in your
regulated environments?
Find the right partner to manage those spaces.
Regulated Environments
The challenge of managing regulated
environments should not distract from the
mission of developing breakthrough products
in life sciences and related industries.
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
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
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.
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.
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.
COPYRIGHT © JONES LANG LASALLE IP, INC. 2014
Thank you
Engage a knowledgeable regulated environments expert
George Wittmann: [email protected]
Dick Auger: [email protected]
Want to learn more about effectively
managing regulated environments?
Click here to read our full paper.