21CFR21中英文对照版(SMART).pdfVIP

(2) Holding rejected components, drug product X4*6}Èf,´@-Ã9Ÿñé˜Ãö1ú71®,´ containers, closures, and labeling before disposition; C^ˆÄ (3) Storage of released components, drug product n|,´@-Ã9Ÿñé˜Ãö1ú71®,´C^ˆÄ containers, closures, and labeling; (4) Storage of in-process materials; ]L$ƒ,´C^ˆÄ (5) Manufacturing and processing operations; +O×ÐýŒÄ (6) Packaging and labeling operations; 5õ¼Cd71®ýŒÄ (7) Quarantine storage before release of drug 9Ÿñn|},´µP¼LÄ/ëC^ˆÄ (8) Storage of drug products after release; n|9Ÿñ,´C^ˆÄ (9) Control and laboratory operations; ×fÔÎP¼ÔýŒÄ (10) Aseptic processing, which includes as 9üýŒÈ5²;F2ƒ,´ (I) Floors, walls, and ceilings of smooth, hard ÄÅ`¯ÃÉñ¼Y8ᯣ%Ê.œÃ˜M’C$5#1× surfaces that are easily cleanable; (ii) Temperature and humidity controls; ÄÅ$YÖ$¯Ö×f (iii) An air supply filtered through high-efficiency ÄÅ0ªD4ÿQxE÷%˜ÃX!“»;E÷%Ãr#qFMŽr#q particulate air filters under positive pressure, w× regardless of whether flow is laminar or nonlaminar; (iv) A system for monitoring environmental conditions; ÄÅ)ß³-#{3+5× (v) A system for cleaning and disinfecting the room ÄÅKFP9ü)ß³,´oL$¼Aî7$5#1Ã#¸3+5× and equipment to produce aseptic conditions; (vi) A system for maintaining any equipment used to ÄÅ×f9ü)ß³,´Aî75$3+5Ä control the aseptic conditions. (d) Operations relating to the manufacture, processing, and packing of penicillin shall be ÄGÅM‚M93P+O×ÃÐú5õAî7+Oצê+X9Ÿñ performed in facilities separate from those used for ,´Aî760 other drug p