This spiral-bound, 5" x 7.5" book is a compilation of the FDA regulations and guidance documents that govern the manufacture, processing, packing or holding of drugs.  It includes such topics as:

• Quality Systems for GMP
• Facilities, Personnel, Equipment
• Packaging, Labeling, Laboratory Controls
• Frequently Asked Questions on GMP
• Records and Reports
• FDA Inspections

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?
• 1-99 copies:  $18.95             • 100-249 copies:  $17.95
• 250-499 copies: $16.95          • 500+ 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
820   Quality System Regulation

•  FDA Guidance Documents

•  ICH Guideline on Good Manufacturing Practice for Active Pharmaceutical Ingredients (Q7A) (US, Step 5)

•  FDA Guidance for Part 11 - Electronic Records; Signatures - Scope & Application

•  Questions and Answers on Good Manufacturing Practices for Drugs

•  PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance

•  Drug Manufacturing Inspections: Compliance Manual for FDA Staff (#7356.002)

•  FDA Guidance on a Quality Systems Approach to CGMP Regulations

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