A Risk Analysis for Production Processes with Disposable Bioreactors-Reference-Cited by-同舟云学术

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A Risk Analysis for Production Processes with Disposable Bioreactors

Published:2013 Issue: Volume: Page:273-288
ISSN:0724-6145
Container-title:Disposable Bioreactors II
language:
Short-container-title:

Author:

Merseburger Tobias,Pahl Ina,Müller Daniel,Tanner Markus

Publisher

Springer Berlin Heidelberg

Link

http://link.springer.com/content/pdf/10.1007/10_2013_244

Reference62 articles.

1. European Commission (2012) Eudralex vol. 4, annex 2: manufacture of biological medicinal products for human use. Brussels

2. International Conference on Harmonisation (2005) Q9: quality risk management. Geneva

3. International Conference on Harmonisation (2008) Q10: pharmaceutical quality system. Geneva

4. International Organisation for Standardisation (2000) Application of risk management to medical devices, ISO 14971. ISO’s Central Secretariat, Geneva

5. International Organisation for Standardisation (2009) Risk management—principles and guidelines, ISO 31000. ISO’s Central Secretariat, Geneva

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