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International Library Service.
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International Library Service
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88
ISA-88 Batch Systems Standards CD -3rd Edition
2006
$340.00
This updated CD compiles the essential ISA batch systems standards:
- ANSI/ISA-88.01-1995, Batch Control Part 1: Models and Terminology (Formerly ANSI/ISA-S88.01-1995)
- ANSI/ISA-88.00.02-2001, Batch Control Part 2: Data Structures and Guidelines for Languages
- ANSI/ISA-88.00.03-2003, Batch Control Part 3: General and Site Recipe Models and Representation
- ANSI/ISA-88.00.04-2006, Batch Control Part 4: Batch Production Records
- ISA-TR88.0.03-1996, Possible Recipe Procedure Presentation Formats
along with a compilation of over 20 ISA Technical Papers on batch systems control and excerpts from Applying S88: Batch Control from a User's Perspective, an excellent tool for better understanding the above standards.
Additionally, the CD contains other important items on batch systems control including:
- Batch XML schemas from World Batch Forum
- 21 CFR 11 on criteria for the FDA acceptance of Electronic Records and Signatures
- 21 CFR 210 on the good manufacturing practices in manufacturing, processing, packing or holding of drugs
- 21 CFR 211 on good manufacturing practices in pharmaceuticals
