ISA-88-06(3Ed)
Batch Systems Standards CD -3rd Edition
ISBN: 978-1-55617-9693
Published: 2006

Price: $320.00

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.