Manufacturing Site Selection & Capacity-Fit Comparison

Deterministic, inspectable scoring for candidate manufacturing sites | Not a black-box AI score

Save site-selection evidence in Program OS
Planning & comparison aid, not a substitute for a formal site qualification audit. This tool applies a transparent, user-adjustable weighted checklist to the attributes you enter for each candidate site. It does not perform an on-site GMP audit, does not query FDA/EMA inspection databases, and does not determine the regulatory filing type required for a site change. A qualified regulatory affairs professional and a formal quality/site-qualification audit must confirm any manufacturing site decision.

Candidate Sites

Scoring Weights (Adjustable)

Weights are relative importance points (not percentages) and are shown re-normalized against the maximum possible score in the report below, so the underlying math stays visible.

Run Comparison

Once site attributes and weights are set, run the comparison to generate a ranked, fully inspectable fit report — every point awarded to every site is shown with its rationale below.

Site-Comparison Report

Define your candidate sites above, adjust weights if needed, and click "Compare Sites & Generate Report" to view the ranked, inspectable output.

Regulatory Reality: Site Changes Are Not Just Operational Decisions

Manufacturing at a new site not currently listed in the approved application is a regulated change, not a purely operational one. Under the FDA framework for changes to an approved application 21 CFR 314.70, adding or changing a manufacturing site for an approved ANDA generally requires a supplement or report to FDA before (or, in narrower cases, shortly after) the change is implemented commercially — commonly discussed in industry as a Prior Approval Supplement (PAS) or a Changes Being Effected in 30 days (CBE-30) submission, depending on the nature and risk of the specific change.

This tool does not classify which filing type applies. Whether a given site addition/change requires a PAS, a CBE-30, or can be reported in an annual report depends on the specifics of the change (e.g., whether it is a new manufacturing site vs. a site already approved for a related product, the criticality of the operation performed there, and current FDA guidance) — this determination must be confirmed by a regulatory affairs professional before committing to a timeline.

Practically: if a candidate site is not yet listed on any approved application for this product, budget real regulatory lead time (potentially many months for a PAS-type change) into any site-selection decision — the "best operational fit" site may not be the fastest path to market if it also carries the heaviest regulatory filing burden.