Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2 - - BioPharm International

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Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2


BioPharm International
Volume 21, Issue 3

CONCLUSION

Cleaning validation is driven by regulatory requirements to ensure that residues from one product will not carry over and cross contaminate the next product. The cleaning program consists of equipment design and qualification, a cleanability study, sampling evaluation, and meeting predetermined acceptance criteria. Dirty and clean hold times are established during cleaning validation. Cleaning validation is supported by approved procedures, training, change control, monitoring, and revalidation. A cleaning validation strategy that is based on the evaluation of potential risks increases success rate and reduces execution time.

ACKNOWLEDGMENTS

The author is thankful to Lara Collier for management support and to Jenna Carlson and Ahmed Bassyouni for reviewing the manuscript and providing comments.

A. Hamid Mollah, PhD, is a senior technical manager for corporate quality and validation at Genentech, Inc., South San Francisco, CA, 650.467.1095,

REFERENCES

1. Mollah AH, White EK. A risk based cleaning validation in biopharmaceutical API manufacturing. BioPharm International 2005;18(11):54-67.

2. US Food and Drug Administration. Guide to inspections of validation of cleaning processes. Rockville, MD; 1993 Jul.

3. Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. Validation master plan installation and operational qualification: Non-sterile process validation. Cleaning validation. Geneva, Switzerland; 2004 Jul.

9. Parenteral Drug Association Office of Science and Technology. Technical report no. 29: Points to consider for cleaning validation. Bethesda, MD; 1998 Aug.


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