I have a question I am hoping you could help me with regarding cgmp; I am working with a bulk manufacturing; by classification I would consider their operations to be for an excipient. I have been trying to find a master reference list that would list out all of the various documents that would be required to be gmp compliant. I understand that there will be variations between manufacturers and products, but I would expect there would be a core list for policy, procedures, forms, protocol, SOP, etc.
I am trying to compare what I currently have within the ISO 9001 to identify what is missing completely or that I would need to modify.[/color]
[COLOR=#000000][FONT=verdana]Any input you could provide would be appreciated.