GMP guidelines for Active Pharmaceutical Ingredients (APIs)


(K) #1

Dear Team
Can you list the Regulatory GMP guidelines for Active Pharmaceutical ingredient.
One i know of is ICH Q7 what are the other regulatory guidelines ?

Appreciate your reply.

regards
Jay


(Ankur Choudhary) #2

Following are some GMP Guidelines for API

  1. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/info-prod/drugs-drogues/actingre-gui-0104-eng.pdf
  2. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf
  3. http://apps.who.int/medicinedocs/documents/s20119en/s20119en.pdf
  4. http://apic.cefic.org/pub/5gmpdev9911.pdf