ISA-88 Batch Systems Standards CD -3rd Edition

ISA Member Price: $296.00 Affiliate Member Price: $333.00 Community Member/List Price: $370.00 Product ISBN/ID: 978-1-55617-9693 Stock Status: In Stock

About

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