HARMONIZATION IMPLEMENTATION OF CURRENT USP REQUIREMENT AND GAMP ON INSTRUMENT QUALIFICATION IN RESEARCH AND DEVELOPMENT LABORATORY WITH RISK MANAGEMENT APPROACH
Based on the requirement of the latest United State Pharmacopeia (USP), chapter 21 Code of Federal Regulation (CFR) part 11, and International Society for Pharmaceutical Engineering Good Automated Manufacturing Practice (ISPE GAMP), qualification of analytical instrument is the most basic things...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/39904 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |