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Pharma and Biotech Page
Presentations and Agendas  

VALUE PROPOSITION & PURPOSE

Special Interest Groups, or SIG's, are groups totally independent of SMRP, which exist for connecting people with a shared interest, to share general information within a portion of the field of "Reliability and Physical Asset Management".

An SMRP "Pharmaceutical and Biotech" Special Interest Group (SIG) could therefore help members learn to, within their respective companies:

• Champion "Pharmaceutical and Biotech" Reliability Compliance and Innovation  
• Communicate (skills & methods) the value of "Pharmaceutical and Biotech" Reliability
• Collaborate with other “Pharmaceutical and Biotech” Organizations, such as ISPE to Focus on Maintenance and Reliability in this Industry while leveraging successful strategies applied in other Industries.
• Differentiate "Pharmaceutical and Biotech" Maintenance and Reliability Compliance from other Industries less regulated
• Show practical applicability of "Pharmaceutical and Biotech" such as answering the FDA’s challenge regarding Utilization of Assets in our Industry
  • FDA is starting to pay attention to "manufacturing capacity utilization."  Congress is concerned about drug shortages; many drugs come from one or two suppliers globally.  Congress is pressing FDA on the problem, and FDA is turning to industry for information. 
  • Last year, industry executives published a global strategy document that contained a discussion about low capacity utilization rates of 30 - 40 percent, and FDA wants to know why this is so. 
  • I bring this up because this “Pharmaceutical and Biotech” SIG can leverage this concern and industry hot button subject.
  • This “Pharmaceutical and Biotech” SIG will answer to how to comply with regulations, using smart approaches to quality assurance, in a way that enhances business outcomes.
• Evaluate whether their maintenance plans/strategies are working
• Use "Pharmaceutical and Biotech" Compliance Driven  Reliability to drive the right changes in strategy and tactics
• Measure the value of changes in strategy and tactics

Through the items listed above, we will be:

• Learning how to make our Employers more profitable
• Helping to advance the practice of reliability engineering in our Industry
• Elevating the understanding of certain concepts and tools within the larger SMRP community, and
• Developing and growing the compliance driven reliability portion of the SMRP Body of Knowledge.

SIG establishment Letter
SIG Activity Agreement
SIG Policies

Pharma and Biotech SubTeam Charters

1. FMECA/RCM SubTeam Charter
2. Benchmarking SubTeam Charter
3. C&Q Links to M&R SubTeam Charter
4. SubTeam Charter Process

FMECA/RCM Survey