西瓜影音苹果版用不了:GMP News: Dedicated Facilities: FDA publishes...
来源:百度文库 编辑:九乡新闻网 时间:2024/05/09 05:00:16
GMP News
30/03/2011
Dedicated Facilities: FDA publishes Draft Guideline
The Code of Federal Regulations 21 CFR § 211.42(c) lays down that the manufacture, processing and packing of penicillin shall be performed in separate facilities, whereof "separate" doesn't necessarily means separate buildings. Isolation within one area can be sufficient. Moreover, paragraph § 211.46(d) requires that air-handling systems for the manufacture of penicillin shall be completely separated from that for other drug products.
In the draft guideline "Non-Penicillin Beta Lactam Risk Assessment: a CGMP Framework" (which both applies to the manufacture of APIs and medicinal products) recommendation is made for non-pencillin beta lactam antibiotics. The document should help manufacturers to evaluate whether separate facilities are necessary or not.
Chapter 3 with the recommendations given by FDA is relatively short. The FDA expects from manufacturers to treat non-penicillin beta lactam-based products in regard to separation exactly like penicillin. The FDA recommends to establish sufficient measures on separation and control in order to avoid cross-contamination risks between
Beta lactam and non-beta lactam products Non-penicillin beta lactams and other non-penicillin beta lactams (cross-reactivity risk)
For the manufacture of a specific class of non-penicillin-beta-lactams (e.g. the cephalosporin family), separate facilities and air handling systems are not mandatory. According to the FDA, production campaigning and cleaning may be sufficient.
Please also see thedraft of the new guideline.
Author
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
30/03/2011
Dedicated Facilities: FDA publishes Draft Guideline
The Code of Federal Regulations 21 CFR § 211.42(c) lays down that the manufacture, processing and packing of penicillin shall be performed in separate facilities, whereof "separate" doesn't necessarily means separate buildings. Isolation within one area can be sufficient. Moreover, paragraph § 211.46(d) requires that air-handling systems for the manufacture of penicillin shall be completely separated from that for other drug products.
In the draft guideline "Non-Penicillin Beta Lactam Risk Assessment: a CGMP Framework" (which both applies to the manufacture of APIs and medicinal products) recommendation is made for non-pencillin beta lactam antibiotics. The document should help manufacturers to evaluate whether separate facilities are necessary or not.
Chapter 3 with the recommendations given by FDA is relatively short. The FDA expects from manufacturers to treat non-penicillin beta lactam-based products in regard to separation exactly like penicillin. The FDA recommends to establish sufficient measures on separation and control in order to avoid cross-contamination risks between
Beta lactam and non-beta lactam products Non-penicillin beta lactams and other non-penicillin beta lactams (cross-reactivity risk)
For the manufacture of a specific class of non-penicillin-beta-lactams (e.g. the cephalosporin family), separate facilities and air handling systems are not mandatory. According to the FDA, production campaigning and cleaning may be sufficient.
Please also see thedraft of the new guideline.
Author
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
GMP News: Dedicated Facilities: FDA publishes...
GMP News: Video Presentation from FDA′s Dr Mo...
GMP News: Production of WFI through Membrane ...
GMP News: New Compilation of Community Proced...
GMP News: Extension of the Variations Regulat...
【drug-news】八大药品面临FDA裁决
GMP News: New EMA Checklist should help Type ...
Shared Dedicated server
News
GMP基本知识
GMP培训教材
Society awards enterprises are mainly dedicated staff dedicated
EMA publishes two advisory Document...
GMP法规内容
GMP标准_
药品GMP检查指南-
兽药GMP培训教材1
新旧GMP对比
China publishes first list of military equipm...
China publishes its first national territory ...
China publishes selection of CPC documents du...
穴位及特效fda
FDA药品申报流程图
药品GMP检查指南1