FDA关于厂房设施的法规条款及翻译(与头孢和青霉素相临的厂房请注意).docx

3.1 Facility Design and Layout厂房设置及布置This page will address various regulatory issues related to this section of the GMP Institute framework.??Click below to view the issues that are relevant to you.Penicillin Issues青霉素问题What do the CGMPs mean by separate facilities? Must the buildings be totally separated, or are the CGMPs satisfied when the floors are physically separated with separate air filtration units installed? CGMP规定独立的厂房是什么意思？厂房必须完全独立吗？在安装有独立的空气过滤系统的情况下，楼层之间采取物理隔离可以吗？Is it acceptable to manufacture penicillin and non-penicillin products in the same facility on a campaign (i.e., the conversion of production facilities to a different product line on a routine basis) basis, with adequate cleaning validation procedures in place?在同一个厂房里生产青霉素和非青霉素产品，在有足够清洁的前提下，可接受吗？Is it acceptable to manufacture penicillin products in the same facility as cephalosporin? 在同一个厂房内生产青霉素和头孢产品可以接受吗？Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non-penicillin solid dosage forms provided there is no further penicillin production in the renovated facility?一个生产制剂的厂房，如果在去除污染和改造的前提下且不会再被用于生产青霉素产品，可否用于生产非青霉素产品，Is there an acceptable level of penicillin residue in non-penicillin drug products? 在非青霉素药品中青霉素的残留标准是多少？If a firms only operation is performing finished packaging operations for bulk tablet and capsule drug products, must it still maintain separate facilities and equipment for packaging penicillin products???如果一个公司的操作仅仅是片剂和胶囊的包装，也必须是独立的厂房及设备吗？What do the CGMPs mean by separate facilities? Must the buildings be totally separated, or are the CGMPs satisfied when the floors are physically separated with separate air filtration units installed? CGMP规定独立的厂房是什么意思？厂房必须完全独立吗？在安装有独立的空气过滤系统的情况下，楼层之间采取物理隔离可以吗？References: 21 CFR 211.42(d) Design, and construction features21 CFR 211.46(d) Ventilation, air filtration, air heating and cooling21 CFR 211.176 Penicillin contaminationFederal Register, 9/29/78 (Vol.43, No.190, Book 2) Preamble to t