Swissmedic Will Accept Certain FDA Inspection Documents as GMP Evidence

Global inspection activity is sending a consistent message. Authorities are still willing to accept well-documented foreign inspection evidence, but they are not relaxing expectations on identity testing, stability programs, visual inspection of sterile products, or quality unit ownership. If your site is preparing a marketing application, a variation, a supplier audit, or an FDA readiness review, the themes below are the ones that will surface first.

## Swissmedic Will Accept Certain FDA Inspection Documents as GMP Evidence

Switzerland has updated its guidance on how foreign manufacturers prove GMP compliance for marketing authorisations and variations. The practical change that quality and regulatory teams need to notice is this: under defined conditions, an FDA inspection report, a valid Certificate of Pharmaceutical Product, an FDA cGMP declaration, or a valid cGMP certificate may be submitted as evidence for both active substance and finished product manufacturers.

That is not a free pass. The evidence must be current and must match the actual manufacturer, site, activity, and product or substance in the procedure. Certificates and foreign inspection reports still have to contain enough information to support a Swiss assessment. Languages and supporting document packs have also been clarified.

**Compliance solution:** Build a living “GMP evidence dossier” for every site in your supply chain. Map each document to site, scope, product family, and expiry or inspection date. Before filing, run a gap check: does the FDA report cover the same building, same process, and same product class? If not, plan a targeted audit or additional certificate rather than hoping the assessor will interpolate.

## FDA Warning Letter Spotlight: Stability, Supplier Qualification, Validation, and Quality Oversight

A recent FDA Warning Letter to an OTC manufacturer again bundled four classic system failures:

- Incoming materials released without a specific identity test, and suppliers not adequately qualified or requalified.

- Stability studies missing humidity control details, missing timepoints, and uninvestigated OOS viscosity results in both accelerated and long-term work.

- No completed process validation for marketed OTC products and no cleaning validation on shared equipment.

- Recurring gasket failures without effective CAPA, weak finished-product API specifications, and a quality unit that did not own the system.

FDA asked for an independent six-system CGMP audit, a full stability remediation plan, and a patient-risk assessment for already distributed batches, including possible notifications or recalls. Promises made after a previous inspection were not enough; execution was.

**Compliance solution:** Treat supplier qualification, identity testing, process validation, cleaning validation, and stability as one connected control strategy, not five separate SOPs. Require at least one specific identity test before use. Do not accept a supplier CoA as a substitute for qualification. Investigate every stability OOS before the next timepoint is due. Close validation protocols before commercial release, not after the inspector asks.

## EU Coordination of GMP Inspections for Centrally Authorised Products

The Union procedure on coordinating GMP inspections for centrally authorised products has been updated. The core model stays the same: a Leading or Supervisory Authority, often with a Supporting Authority, so workload and continuity are shared across Member States.

The useful clarification is operational. Some sites do not need a Supporting Authority—for example small manufacturers, certain QC laboratories, or sites with only one supervisory authority for CAP products. In those cases one authority acts as both lead and support and also carries the inspection cost.

**Compliance solution:** For CAP sites, confirm who your Supervisory Authority is and whether a Supporting Authority is assigned. Inspection logistics, document language packs, and cost expectations change when only one authority is involved. Keep a single inspection-readiness owner so the site does not brief two agencies with two different stories.

## Visual Inspection of Steriles: Qualification Kits Must Actually Challenge Detectability

FDA criticised a sterile injectable visual inspection program because inspectors were not robustly qualified, the qualification kit was not representative, and records were too thin to reconstruct who could detect what.

The agency’s position is straightforward. Visible particle detection is probabilistic. Kits must challenge operators across the particle sizes that can appear in the product, including particles in the 100–150 µm range. A kit that only contains large, easy-to-see particles does not prove the line can keep product “essentially free of visible particulates.” USP <790> expectations should sit inside procedures, not in a binder on the shelf.

**Compliance solution:** Rebuild the qualification kit from product history: fibre, glass, rubber, intrinsic particles, and the smaller sizes that actually occur. Document visual acuity, lighting, pace, and defect mix. Requalify after process, container, or lighting changes. Trend inspection rejects against complaints so the kit stays representative instead of becoming a museum piece.

## Why It Matters

Inspection findings are no longer isolated technical notes. They now block filings, trigger recalls, and travel across borders through reliance and work-sharing. A weak FDA inspection file can delay a Swiss variation. An uninvestigated stability OOS can become a Warning Letter and a market action. A visual inspection program that looks busy on paper can still fail because the kit never challenged the operator.

For quality professionals, the common thread is evidence that is current, scoped, and owned by the quality unit. Inspectors are testing whether the system works on a Tuesday afternoon, not whether a SOP exists.

## Practical Next Steps

1. Inventory GMP evidence for every manufacturing and testing site used in pending applications or variations. Flag documents older than the last major process change.

2. Audit incoming material testing this month: specific identity test, supplier qualification status, and CoA verification practice.

3. Pull open stability studies. Close any uninvestigated OOS before the next pull point.

4. Confirm process and cleaning validation status for every commercial SKU on shared equipment.

5. Review visual inspection qualification kits against 100–150 µm challenge particles and USP <790>.

6. Assign one inspection coordinator per site for EU CAP inspections so Leading and Supporting Authority requests do not fork your story.

7. Commission an independent six-system readiness review if you have overdue CAPA, recurring equipment failures, or a previous commitment that is still open.

Stay inspection-ready, not inspection-surprised.

---

**Related keywords:** GMP inspections, FDA Warning Letter, Swissmedic GMP evidence, cGMP compliance, supplier qualification, identity testing, stability program OOS, process validation, cleaning validation, visual inspection of parenterals, USP 790, centrally authorised products inspections, quality unit oversight, CAPA effectiveness, inspection readiness