title: ICH Q7A; 4.40 containment of beta-lactam antibiotics: an industry perspective.
abstract: 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.
authors.affiliation: Shionogi & Co., Ltd., Manufacturing, Hyogo, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kasai
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Okubo
authors.forename: Akira
authors.initials: A
authors.lastname: Yamanaka
authors.forename: Masayuki
authors.initials: M
authors.lastname: Takahira
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Takeuchi
authors.forename: Kazuichi
authors.initials: K
authors.lastname: Nakamura
mesh_terms: D000707:Anaphylaxis / Q000139:chemically induced; D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D047090:beta-Lactams
chemical_list: D000900:Anti-Bacterial Agents; D047090:beta-Lactams