Regulatory Open Forum

Dear Friends,

In accordance with FDA guidance titled "Facility Readiness: Goal date decisions under GDUFA", an ANDA applicant should access whether each facility is ready for inspection before checking the appropriate box on Form FDA 356h. FDA considers a facility that is ready for inspection to be one that complies with current good manufacturing practice (CGMP) requirements and meets the following criteria related to the application product: 

• Facility operations, methods, and product formulation are the same as those described in the application

• Data at the facility are complete and accurate, and are consistent with data in the application

• The facility is ready for commercial manufacturing

In reference to above guidance, seeking your advice on below scenario:

• Facility has several manufacturing lines, previously inspected by FDA having satisfactory inspection status and several approved ANDA products being manufactured on these lines.
• If the facility readiness is selected as not ready in the 356h form of an ANDA application, due to the particular manufacturing line where the commercial product is supposed to be manufactured is undergoing modification and this line is isolated from other active manufacturing lines, whether this facility readiness selection applies only to this particular ANDA product alone or does it applies to the whole facility as such, in which several other manufacturing lines are present?

Looking forward to your valuable inputs.

The specific ANDA application product should be checked yes if this product line is ready for manufacturing! It does not apply to the whole facility since your site is not new, it has already approved products manufactured and previously inspected!