000			01769nam a2200169Ia 4500
008			140223b2009 xxu||||| |||| 00| 0 eng d
020			_a9780849395291 _c0.00
082			_a681.761 _bHAI
100			_aHaider, Syed Imtiaz
245			_aValidation Standard Operating Procedures
250			_a2nd ed
260			_aNew York _bInforma Healthcare USA, Inc. _c2009
300			_a1118p
500			_aPCG00235 Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control. stearothermophilus strip, check physical appearance, daily production start, personnel bioburden, sterility during the aseptic processing, challenge aerosol penetration, endotoxin vials, spore bioburden, study including temperature, validation team members, filling machine parts, allowable carryover limit, endotoxin challenge test, validation officer, bioburden method, total aerobic viable count, sanitization records, following documentation requirements, installation qualification review, maximum tunnel speed, vial washing machine, attachment nos, cycle printouts, spiked vials, validation standard operating procedures
890			_aUSA
995			_AHAI _B008181 _CGEM-GEN _D4643.93 _E0 _F049 _G41100 _H0 _I0.00 _J6495.00 28.5% _L20090226 _M10 _UC _W20090328 _XBooks India _ZReference
999			_c16402 _d16402