CDER Guidance Agenda Published

GMP News
12 March 2008

CDER Guidance Agenda Published

Not long ago, the FDA Center for Drug Evaluation and Research (CDER), which is competent for the supervision and registration of the "classical" medicinal products and biotechnological products, published its list of guidances planned for the fiscal year 2008. On three pages, the planned documents are divided into different categories from A as in advertising to P as in procedural.

Guidelines regarding GMP can be found in the "chemistry" category. An example for this is a guideline on Change Control, which will bear the title "CMC Post-Approval Changes Reportable in an Annual Report". Another planned document concerns sterilisation for registration purposes ("Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes").

The most important "GMP category", however, is the "compliance" category. It includes the following publications:

  • Active Pharmaceutical Ingredient (API)
  • Medical Gas
  • Non-Penicillin Beta-Lactam Contamination
  • Pharmacy Compounding of Human Drugs - Compliance Policy Guide, Section 460.200
  • Penicillins and Their Definition
  • Pre-Launch Activities Importation Request (PLAIR)
  • Process Validation: General Principles and Practices

As in the past years, the revision of the Process Validation Guideline is on the agenda again.

To manufacturers of combination products (medical devices with medicinal products), another expected guideline will be of interest: Drug Diagnostic Co-Development.

The complete list of planned guidelines can be found at:

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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