Pharmaceutical Quality Resources

As part of an application to make a drug applicants are expected to show that they can consistently produce a quality product.  The following resources are helpful in achieving this goal, and may also be helpful for other types of products such as OTC monograph products:

• Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations
• Generic Drugs: Information for Industry
• Premarket Focused, Quality Related Guidance
  • International Council on Harmonisation-Quality
  • Pharmaceutical Quality/CMC
  • Pharmaceutical Quality/Microbiology 
  • Pharmaceutical Quality/Manufacturing Standards (CGMP)  
• Drug Master Files
• Inactive Ingredient Database

In addition to our cGMP regulations, the following resources expand on FDA’s post-application expectations for manufacturers of drug substances and drug products.

• The following contain lists of CGMP related guidance (i.e. operating a drug manufacturing facility to acceptable standards on an ongoing basis). 
  • Pharmaceutical Quality/Manufacturing Standards (CGMP)
  • International Council on Harmonisation-Quality
• All CDER Guidances
• Report a Product Quality Issue: Identify quality defects in distributed drug products that may present a potential safety threat