PT  - JOURNAL ARTICLE
AU  - Takayuki Kasai
AU  - Tsuneo Okubo
AU  - Akira Yamanaka
AU  - Masayuki Takahira
AU  - Mitsuo Takeuchi
AU  - Kazuichi Nakamura
TI  - ICH Q7A; 4.40 Containment of Beta-Lactam Antibiotics: An Industry Perspective
DP  - 2002 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 312--317
VI  - 56
IP  - 6
4099  - http://journal.pda.org/content/56/6/312.short
4100  - http://journal.pda.org/content/56/6/312.full
SO  - PDA J Pharm Sci Technol2002 Nov 01; 56
AB  - The ICH Q7A guidance was finalized at the Fifth International Conference on Harmonization in San Diego, Nov. 9-11, 2000, and has been implemented in Japan since Nov. 2, 2001. However, in ICH Q7A; 4.40, Containment, there is no clear stipulation about whether a dedicated or multi-purpose facility should be employed in the production of highly sensitizing materials of different types of beta-lactam antibiotics, such as cephalosporins and cephems. This study presents the threshold levels for the induction of anaphylaxis by beta-lactam antibiotics to show that it is possible to use a multi-purpose facility for the production of several different types of beta-lactam antibiotics except for penicillins, if there are validated cleaning standards based on threshold values.