MARC

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003 OCoLC
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007 cr un|---aucuu
008 191218s2020 enk o 000 0 eng d
040 |a OPELS  |b eng  |e rda  |e pn  |c OPELS  |d OCLCF  |d EBLCP  |d UKMGB  |d YDXIT  |d YDX  |d N$T  |d SFB  |d OCLCO  |d OCLCQ  |d OCLCO  |d K6U  |d OCL  |d OCLCQ  |d OCLCO 
015 |a GBB9H1814  |2 bnb 
016 7 |a 019576715  |2 Uk 
019 |a 1129223908 
020 |a 012809446X  |q (electronic book) 
020 |a 9780128094464  |q (electronic bk.) 
020 |z 9780128094129 
035 |a (OCoLC)1131863429  |z (OCoLC)1129223908 
050 4 |a RS201.P37 
082 0 4 |a 615.19  |2 23 
245 0 0 |a Principles of parenteral solution validation :  |b a practical lifecycle approach /  |c edited by Igor Gorsky, Harold S. Baseman. 
264 1 |a London, United Kingdom :  |b Academic Press,  |c 2020. 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Expertise in pharmaceutical process technology series 
588 0 |a Print version record. 
505 0 |a 1 Process Validation: Design and Planning -- 2 Aseptic Process Validation: Aseptic Process Simulation Design -- 3 Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals -- 4 Equipment Cleaning Process -- 5 Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System -- 6 Use of Statistics in Process Validation -- 7 Process Validation Stage 1: Parenteral Process Design -- 8 Process Validation Stage 2: Parenteral Process Performance Qualification -- 9 Process Validation Stage 3: Continued Process Verification -- 10 Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter -- 11 Environmental Monitoring -- 12 Isolators -- 13 Post Aseptic Fill Sterilization and Lethal Treatment 
650 0 |a Parenteral solutions  |x Quality control. 
650 0 |a Drugs  |x Standards. 
650 0 |a Drug development. 
650 0 |a Quality control. 
650 1 2 |a Drug Development  |0 (DNLM)D000076722 
650 1 2 |a Drug Development  |x standards  |0 (DNLM)D000076722Q000592 
650 2 2 |a Quality Control  |0 (DNLM)D011786 
650 6 |a Solutions (Pharmacie)  |0 (CaQQLa)201-0152955  |x Administration parent�erale  |0 (CaQQLa)201-0152955  |x Qualit�e  |0 (CaQQLa)201-0380200  |x Contr�ole.  |0 (CaQQLa)201-0380200 
650 6 |a M�edicaments  |x Normes.  |0 (CaQQLa)201-0014648 
650 6 |a M�edicaments  |x D�eveloppement.  |0 (CaQQLa)201-0306620 
650 6 |a Qualit�e  |x Contr�ole.  |0 (CaQQLa)201-0072623 
650 7 |a quality control.  |2 aat  |0 (CStmoGRI)aat300056087 
650 7 |a Quality control  |2 fast  |0 (OCoLC)fst01084966 
650 7 |a Drug development  |2 fast  |0 (OCoLC)fst00898670 
650 7 |a Drugs  |x Standards  |2 fast  |0 (OCoLC)fst00898923 
650 7 |a Parenteral solutions  |x Quality control  |2 fast  |0 (OCoLC)fst01053388 
700 1 |a Gorsky, Igor,  |e editor. 
700 1 |a Baseman, Harold,  |d 1956-  |e editor. 
776 0 8 |i Print version:  |t Principles of parenteral solution validation  |z 9780128094129  |w (OCoLC)1124287018 
830 0 |a Expertise in pharmaceutical process technology series. 
856 4 0 |u https://sciencedirect.uam.elogim.com/science/book/9780128094129  |z Texto completo