This spiral-bound, 5.5" x 8.5" book is a compilation of regulations and guidance documents from the US, EU and Canada governing the cleaning of drug and biological product manufacturing equipment. (396 pages)
How is this Book Used?
• As a training aid for new and existing staff
• As an on-the-job reference source
• As a preparatory aid for an FDA inspection
What's the Price?
• 1-249 copies: $18.95 • 250-499 copies: $17.95
• 500-749 copies: $16.95 • 750+ copies: $15.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• CFR Title 21: Food and Drugs (As of April 1, 2024)
Parts 11 Electronic Records/Electronic Signatures
210 Current Good Manufacturing Practice in
Manufacturing, Processing, Packing, or Holding of
Drugs; General
211 Current Good Manufacturing Practice for Finished
Pharmaceuticals
600 Biological Products: General
• The Rules Governing Medicinal Products in the European
Community - Volume 4: Good Manufacturing Practice,
Medicinal Products for Human and Veterinary Use
(Revised to April 1, 2024)
• FDA Guide to Inspections, Validation of Cleaning Processes
• Recommendations on Validation Master Plan, Installation
and Operational Qualification, Non-Sterile Process
Validation, Cleaning Validation (Document PI 006-3)
Pharmaceutical Inspection Co-operation Scheme
• ICH Q7: Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients
• Canadian Cleaning Validation Guidelines (Guide-0028),
Health Canada
• Guidance on Aspects of Cleaning Validation in Active
Pharmaceutical Ingredient Plants
Active Pharmaceutical Ingredients Committee (APIC)
