TY - JOUR T1 - ICH Q7A; 4.40 Containment of Beta-Lactam Antibiotics: An Industry Perspective JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 312 LP - 317 VL - 56 IS - 6 AU - Takayuki Kasai AU - Tsuneo Okubo AU - Akira Yamanaka AU - Masayuki Takahira AU - Mitsuo Takeuchi AU - Kazuichi Nakamura Y1 - 2002/11/01 UR - http://journal.pda.org/content/56/6/312.abstract N2 - 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. ER -