仅供参考,在国外并不要求独立厂房,独立的facility应该就可以了!
Subpart C—Buildings and Facilities§211.42 Design and construction features. (d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.
142. Another comment requested clarification of the meaning of the word "separate" in 211.42(d).
The Commissioner's intent in this paragraph is to require the isolation of penicillin production operations from operations for nonpenicillin products. Separation can be achieved in a facility, building, or plant by effectively isolating and sealing off from one another these two types of operations. This does not necessarily mean separation by geographical distance or the placement of these operations in separate buildings. Effective means can almost certainly be developed to separate such activities from one another to prevent cross-contamination problems within a single building. An example of the means of separation can be found in the discussion of air-handling systems in this
preamble under paragraph 172.
§211.46 Ventilation, air filtration, air heating and cooling.
(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.
149. One comment said proposed 211.46(e)(211.46(d))now should specify whether the air-handling system is intended for outgoing or incoming air. There is no single answer to this point since the specific requirements for a particular installation will depend on individual circumstances. The purpose of the requirement is that no cross-contamination occur between penicillin and nonpenicillin operations. The means by which the objective is achieved may require filtration of incoming air of filtration of outgoing air or both. |