Risk Assessments

  • Overview
  • Why Work With NSF?

Risk assessments of your firm’s operations identify critical process parameters and help you understand potential risk areas. Our experts conduct risk assessments by evaluating historical data related to the operations under review and assessing data trends, deviations, investigations, non-conformances and other relevant information.

Once risks are identified, various risk methodologies can be employed to characterize the risks and implement targeted remediation and mitigation efforts where necessary. Traditional models classify risks based on severity and probability of occurrence. We also employ more advanced models specific to the situation being analyzed. Our risk assessment matrix uses multiple variables and weighting (as appropriate) to assign risk prioritization numbers for each risk parameter or attribute. Risks identified as high, or whose risk level is considered unacceptable, can be corrected to achieve an acceptable risk profile as part of an overall risk control strategy.

Our experts at NSF Pharma Biotech have been helping companies conduct risk assessments for many years. We have developed models to assess the risks associated with straightforward items and minor processing changes, as well as with complex processes requiring sampling plans for over 30 product types with varying therapeutic significance and patient safety factors.

For more information about NSF Pharma Biotech services in quality systems and compliance in the U.S., email uspharma@nsf.org or call +1 202.822.1850.

For more information about NSF Pharma Biotech services in quality systems and compliance in Europe, email pharmamail@nsf.org or call +44 1751 432 999.

Why Work With NSF?

Our team includes former regulatory inspectors and industry experts with decades of experiences  helping companies conduct risk assessments.  Our experts, one of whom was the European industry topic leader on the ICH Q9 expert working group, can help you interpret the requirements of ICH Q9. We not only provide you with a comprehensive risk assessment, but also work with you to identify effective and efficient risk control measures, where necessary.

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