Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 1 - Best practices from Big Biotech, including how to handle new product introductions. - BioPharm International

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Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 1
Best practices from Big Biotech, including how to handle new product introductions.


BioPharm International
Volume 21, Issue 2

REFERENCES

1. US Food and Drug Administration. Guidance for industry. Current good manufacturing practice for finished pharmaceuticals. Rockville, MD; 2006 Apr.

2. European Commission, Enterprise Directorate General. EudraLex, vol.4, Medicinal products for human and veterinary use: Good manufacturing practice. Office for Official Publications of the European Communities: Luxembourg; 2007 Mar.

3. International Conference on Harmonization. Q7, Good manufacturing practice guide for active pharmaceutical ingredients. Geneva, Switzerland; 2000 Nov.

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

5. 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 July.

6. Canada Health Products and Food Branch Inspectorate. Guidance Document. Cleaning validation guidelines: Drug and health products. Health Canada: Ottawa, Canada; 2002 Spring.

7. World Health Organization. Supplementary guidelines on good manufacturing practices: Validation. Geneva, Switzerland; 2005.


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