Biomedical Engineering Reference
In-Depth Information
returns may be reached wherein mitigations are too costly or impractical to imple-
ment. At this point, one must determine if benefits outweigh the potential risks
and decide if utilization of the material is warranted.
The mitigations in this example included supplier audits to assess compliance
with Health Authority regulations and the inclusion of process steps, that is,
filtration and irradiation to reduce particle load and microbial contamination. In
addition, testing in compliance with regulatory requirements was identified as an
additional mitigation to verify serum quality.
Risk acceptance : Risk acceptance is the act of determining if the risks remain-
ing after all mitigations have been implemented is acceptable. In this example,
after implementing the risk reduction activities, all risks were assessed as being
either broadly acceptable or as low as reasonably practical. No further mitigations
were identified as being possible.
Risk communication : Risk communication involves notifying key stakeholders
of the conclusion of a risk assessment. The information communicated should
include an assessment of residual risks and a recommendation of further action,
that is, the acceptance or rejection of the material in question. In this example,
the overall risk of using FBS was deemed acceptable and key stakeholders should
be so notified.
Risk review : A review of the risk analysis should be performed if there is a
change to the process or if new hazards are identified. Such changes may impact
the mitigations previously identified and/or alter the residual risk inherent in the
process.
REFERENCES
1. Federal Register 2008 Jul 2;73(128):37973.
2. ICH Q9, Quality Risk Management. 2005 Nov.
3. ICH Q8 (R2). Pharmaceutical Development. 2009 Aug.
4. ICH Q6B. Specifications: Test Procedures and Acceptance Criteria for Biotechnolog-
ical/Biological products. 1999 Mar.
5. Nosal R, Tom Schultz, PQLI. Definition of criticality. J Pharm Innov 2008;3:69-78.
6. Beck G, Schenerman M, Dougherty J, Cordoba-Rodriguez R, Joneckis C, Mire-Sluis
A, McLeod LD. Raw material control strategies for bioprocesses. BioProcess Int
2009;7(8):18-19.
7. EMEA/CVMP/743/00. Guideline on Requirements and Controls Applied to Bovine
Serum used in the Production of Immunological Veterinary Medicinal Products. Avail-
able at http://www.emea.europa.eu/pdfs/vet/iwp/074300en.pdf. Accessed May 2011.
8. CPMP/BWP/1793/02. Note for Guidance on the Use of Bovine Serum in the Manufac-
ture of Human Biological Medicinal Products. Available at http://www.emea.europa
.eu/pdfs/human/bwp/179302en.pdf. Accessed May 2011.
9. EMEA/410/01, rev. 2: Note for guidance on minimizing the risk of transmitting
animal spongiform encephalopathy agents via human and veterinary medicinal prod-
ucts adopted by the Committee for Proprietary Medicinal Products (CPMP) and by
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