RISK EVALUATION FROM FMEA TABLE
This is the final step in risk assessment using FMEA. To perform the risk evaluation, an RPN number was calculated as demonstrated
in Table III. For the chosen scale of analysis, the maximum RPN is 1000, the minimum is 1. The highest value observed was
280, the lowest was 56. The calculated RPNs are plotted in Figure 3. The action threshold was assumed to be 30 and unit operations
having an RPN greater than or equal to 30 were included in the scope of process validation.
Figure 2. A process for production of mAbs considered for FMEA.
Figure 3. Calculated risk priority numbers (RPNs) from the actual process-validation failure mode’s effects.
This article covers the use of risk-based approaches to evaluate the scope of process-validation activities. The use of any
particular tool will depend on a company's in-house expertise. The tools described above (i.e., FTA and FMEA) can be used
alone or in combination with others. FTA is a top-down approach, whereas FMEA is bottom-up. The use of risk anlaysis also
provides a consistent method for evaluating different risks on product quality. Further benefits of using risk-based approaches
in process validation are shown in Table IV.
Tarun Jain and Ashok Kumar are in the Department of Biotechnology and Environmental Sciences at Thapar University, Patiala-147004, India, tel. +91 9780207803, firstname.lastname@example.org
1. FDA, Guideline on General Principles of Process Validation (Rockville, MD, May 1987).
2. ICH, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (August 2001).
3. A. Hamid Mollah, Bioprocess Int., 2 (9). 28–34 (2004).
4. WHO, Expert Committee on Specifications for Pharmaceutical Preparations, 37th Report, WHO Technical Report Series 908.
World Health Organization, Geneva (2003).
5. J.M. Juran and A.B. Godfrey, Juran's Quality Handbook, 5th edition (McGraw Hill, Columbus, OH, 1999).