Swissmedic Updates Technical Interpretation on Container-Specific Identity Guarantee of Starting Materials

Swissmedic has published version 6.0 of the Technical Interpretation “Requirements for the container-specific guarantee of the identity of starting materials.”

The document, classified as public and valid from 11 August 2026, defines requirements for suppliers of starting materials that wish to guarantee container-specific identity to their customers.

Purpose and Scope

The technical interpretation applies to suppliers of starting materials that wish to guarantee container-specific identity under the Rules of Good Manufacturing Practice for medicinal products in small quantities.

It also applies to Swiss inspectorates conducting inspections under Swissmedic jurisdiction, including the Swissmedic Inspectorate and cantonal inspectorates.

Regulatory Background

Swissmedic explains that, under the Therapeutic Products Act and Pharmacopoea Helvetica, medicinal products and pharmaceutical excipients placed on the market must meet Pharmacopoeia requirements.

The user of starting materials for the manufacture of medicinal products in small quantities remains responsible for ensuring that the starting materials have the required quality.

Where a manufacturer or supplier guarantees the required quality of starting materials on a batch-specific basis, the user may only need to test for identity. However, if identity testing is also to be waived, the supplier must guarantee identity on a container-specific basis and obtain Swissmedic approval for the required quality assurance measures.

Basic Requirements for Approval

Swissmedic states that a user of starting materials can waive identity testing only if the supplier’s manufacturing establishment licence explicitly authorises the supplier to guarantee identity on a container-specific basis.

To be approved, a company must meet several basic requirements, including:

• inspection according to the technical interpretation;

• a valid licence for manufacturing medicinal products and wholesale trading in non-ready-to-use medicinal products;

• filling starting materials into containers and labelling those containers itself;

• compliance with applicable GMP requirements;

• quality assurance measures capable of verifying the identity of starting materials so the user can waive identity testing.

Packaging, Labelling and Risk Controls

The document sets detailed requirements for packaging and labelling systems.

Swissmedic expects implemented measures to be supported by well-founded risk analysis and comprehensively documented. Where active substances or excipients are transferred from original packaging to a different packaging type, the repacker must define the retest or expiry date based on stability evidence for the new packaging material.

The packaging system must also ensure that the contents of a packaging order are homogeneous, that the identity of each received bulk container is tested, that packaging integrity is guaranteed and that the label declaration matches the contents.

Certificates of Analysis and Batch Traceability

Swissmedic requires the certificate of analysis to be clearly valid for the packaged starting material.

The certificate and packaging must indicate both the original manufacturer of the starting material and the repacker, together with their addresses.

The entirety of containers filled as part of a packaging order constitutes a separate filled batch, and containers belonging to that batch must be clearly identifiable. If a certificate of analysis is issued for an individual container, individual container labelling is required.

Swissmedic also clarifies that specification sheets cannot replace certificates of analysis.

Additional Quality Assurance Expectations

The technical interpretation recommends machine-readable labelling systems to ensure that each label clearly corresponds to the intended container and to minimise human labelling errors.

It also expects companies to print labels themselves wherever possible, reconcile printed labels, reconcile filled batch weight, investigate deviations or complaints thoroughly and initiate corrective actions.

The company must also clarify whether the recipient is authorised to manufacture medicinal products within the relevant Pharmacopoea Helvetica scope. Further distribution to distributors is not permitted.

Documentation and Version Changes

Authorisation to guarantee the identity of starting materials on a container-specific basis is listed in the Swissmedic establishment licence as an approved manufacturing activity.

Version 6.0 includes translation into English, repeal of the German and French versions, updates to GDP references and clarification of requirements regarding expiry dates when a new packaging type is used and labelling systems to reduce mislabelling risk.

Impact on Manufacturers and Suppliers

For suppliers and manufacturers of starting materials, the updated technical interpretation reinforces the importance of robust GMP controls, documented risk analysis, traceable packaging operations and clear container-level identity assurance.

Companies should pay particular attention to:

• Swissmedic licence authorisation;

• inspection readiness;

• container-specific identity controls;

• packaging and labelling risk analysis;

• stability evidence for repackaged materials;

• testing of received bulk containers;

• certificate of analysis accuracy;

• machine-readable labelling;

• label and weight reconciliation;

• deviation and complaint investigation;

• recipient qualification and distribution limitations.

For companies supplying starting materials in Switzerland, the key message is that waiving identity testing by the user requires strong, inspected and licensed quality assurance controls at container level.