Validation of Bulk Pharmaceutical Chemicals

Interpharm Press, Inc.ditorial direction of Berry and Harpaz, a team of 13 industry experts has written the definitive guide to the validation of bulk pharmaceutical chemicals (active pharmaceutical ingredients). This extensive book provides the step-by-step "what to do" and "how to do it" for FDA acceptable validation of BPC manufacture.

While the pharmaceutical industry has concentrated on validation of finished drug products and processes, reality is that the validation of the bulk pharmaceutical chemical, both active pharmaceutical ingredient (API) and excipient, has consumed major portions of FDA thinking. Review of FDA warning letters shows an ever increasing concern with the validation of BPCs. Berry and Harpaz have recognized the need for a thorough, comprehensive and complete book on the "what to" and the "how to."

Chapters include:

• The Legal Framework for the Regulation of Bulk Pharmaceutical Chemicals
  
• The Legal Basis for Validation
  
• Drug Master Files
  
• BPC Terminology and Documentation
  
• BPC Process Validation: A Case Study
  
• Bulk Pharmaceutical Chemical Validation: An Overview and Comparative Analysis
  
• Validation of Sterile Bulk Pharmaceutical Chemicals
  
• Validation of Biotechnology Bulk Pharmaceuticals
  
• Quality Assurance Systems
  
• Cleaning for Bulk Pharmaceutical Chemicals (BPCs)
  
• Vendor Qualification and Certification
  
• Microbiological Attributes of Bulk Pharmaceutical Chemicals
  
• Excipients: Facility, Equipment, and Processing Changes

If you manufacture BPCs, or if you purchase BPCs and need to audit the BPC vendor, this text is absolutely required reading. Put these experts on your bookshelf to constantly advise and guide you through the maze of Validation of Bulk Pharmaceutical Chemicals.

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