Inspection Guidelines and Guidances

• GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS 
  
• Manufacture, Processing or Holding of Active Pharmaceutical Ingredients (DRAFT) - Available on CDERs Guidance Page - as an Adobe PDF file or in Wordperfect format

• GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER'S - CGMPR'S 
  

• GUIDE TO INSPECTIONS OF FOREIGN PHARMACEUTICAL MANUFACTURERS

• GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS

• GUIDE TO INSPECTIONS OF MICROBIOLOGICAL PHARMACEUTICAL QUALITY CONTROL LABORATORIES 

• GUIDE TO INSPECTIONS OF ORAL SOLUTIONS AND SUSPENSIONS 

• GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONTROL LABORATORIES 

• GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES FOR DEVELOPMENT AND VALIDATION 

• GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS

• GUIDE TO INSPECTIONS OF VALIDATION OF CLEANING PROCESSES 

• GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS 

• GUIDE TO INSPECTIONS OF INTERSTATE CARRIERS AND SUPPORT FACILITIES

• GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS 

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Bruce G. Berger
1559 Riverdale Drive
Oldsmar, FL 34677
Phone 813-786-3954.
Copyright © 1997 [CMC Applications]. All rights reserved.
Revised: September 01, 1997.