Section 8.5 states: “Production operations should be conducted in a manner that prevents
contamination of intermediates or APIs by other materials.” Then it goes on and says precautions
to avoid contamination should be taken when APIs are handled after purification. So if after
purification the API is exposed to the environment, you need to consider and actually implement,
appropriate controls to avoid any contamination of the API. What those controls entail is really up
to you. Whatever you feel is appropriate and will accomplish the intended purpose.
