RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 312
OP 317
VO 56
IS 6
A1 Kasai, Takayuki
A1 Okubo, Tsuneo
A1 Yamanaka, Akira
A1 Takahira, Masayuki
A1 Takeuchi, Mitsuo
A1 Nakamura, Kazuichi
YR 2002
UL http://journal.pda.org/content/56/6/312.abstract
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.