Strategies for developing a robust cleaning process: Part I: Application of quality by design to cleaning

American Pharmaceutical Review

Volumn 13, Issue 5, 2010, Pages 77-80

  Sharnez, Rizwan ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

WATER;

CLEANING; ENERGY; EQUIPMENT; FLOW RATE; PRESSURE; QUALITY CONTROL; REVIEW; TEMPERATURE; VALIDATION PROCESS;

EID: 77956410177     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (16)

1. US Food and Drug Administration: Guidance for Industry: Q 10 Quality Systems Approach to Pharmaceutical cGMP Regulations, Sept 2006. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ default.htm
2. Bert Frohlich: QbD: Still in Design? PDA Letter, Vol. XLIII, Issue #9, Oct 2007.
3. Chi-wan Chen, Deputy Director ONDQA, CDER, FDA: A FDA Perspective on QbD: Regulatory Watch 2007 Conference, Robbinsville, NJ, Sept. 2007.
4. Kourti, T., Quality by Design in the Pharmaceutical Industry: The Role of Multivariate Analysis, American Pharm. Review; p. 118-123, May/Jun 2009.
5. Glodek, M., et al., Process Robustness - A PQRI White Paper; Pharm. Eng. 26 (6), 1-11, Nov-Dec 2006.
6. Sharnez, R., Taking the guesswork out of validation; J. of Validation Technology, Vol 14, No. 3, p. 27-31, 2008.
7. Sharnez, R., Leveraging Small-Scale Models to Streamline Validation; J. of Validation Technology, Vol 14, No. 4, p. 19-22, 2008.
8. Sharnez, R., and Klewer, L., Parametric Release for Cleaning, Part I: Process Characterization; J. of Validation Technology, Vol 14, No. 8, p. 29-35, 2009.
9. Sharnez, R., et al., In Situ Monitoring of Soil Dissolution Dynamics: A Rapid and Simple Method for Determining Worst-case Soils for Cleaning Validation; PDA Journal of Pharm. Sc. & Tech., Vol 58, No. 4, p. 203-214, July-Aug 2004.
10. Canhoto, A., A Novel Bench Scale Apparatus to Model and Develop Biopharmaceutical Cleaning Procedures; J. of Validation Technology, Vol 11, Nov 2004.
11. Pluta, P., Laboratory Studies in Cleaning Validation; Journal of Validation Technology, Vol. 13, No. 4, 2007.
12. Hoist, B., Developing a Cleaning Process: Cleaning in Development; Journal of GXP Compliance, Vol. 10, No. 3, 2006.
13. Sharnez, R., Emerging Concepts in Cleaning Validation, Part I - Streamline New Product Introductions with Master Soils; J. of Validation Technology, Vol. 15, No. 4, p. 24-29, 2009.
14. Sharnez, R., Unpublished results.
15. Bird, R., W. Stewart and E. Lightfoot, Transport Phenomena, Second Edition; John Wiley & Sons, p. 45-47, 2007.
16. Kramers, H., and P. J. Kreyger, Mass transfer between a flat surface and a falling film; Chemical Engineering Science, Vol 6, p. 42-48, 1956.