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Now Shipping April 2017 Books

Book 4B:  2017 International Reference on Cleaning Validation under Good Manufacturing Practice

Book 4B: 2017 International Reference on Cleaning Validation under Good Manufacturing Practice

$ 16.95

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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:  $16.95             • 250-499 copies:  $15.95
• 500-749 copies: $14.95          • 750+ copies:  $13.95

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, 2017)
       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, 2017)

                        
• 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) (September 2016)

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