GMP guidelines for Active Pharmaceutical Ingredients (APIs)

GMP
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

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. ICH Official web site : ICH
  3. http://apps.who.int/medicinedocs/documents/s20119en/s20119en.pdf
  4. http://apic.cefic.org/pub/5gmpdev9911.pdf
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