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Our five certificates

Certification Assurance International (CAI) has issued Lyotek Labs five certificates. Each one is published here as the PDF we received, with its number, its issue date and its expiry date.

  1. Certificate of Compliance

    cGMP

    Manufacturing practice

    Covers how our peptides are made and checked, from raw material qualification and formulation through filling and freeze-drying to finished-product testing and batch release.

    View certificate (PDF) for cGMP, opens in a new tab
    Standard
    cGMP (21 CFR Part 111:2020)
    Certificate no.
    SWS-CGMP-747
    Issued
    Valid until
    Issued by
    Certification Assurance International
    Assessment
    Virtual guided audit

    Scope, as printed

    Manufacturing and Quality Control of Lyophilised Peptide Products including Raw Material Qualification, Formulation, Sterile Filtration, Aseptic Vial Filling, Freeze-Drying, Sealing, Packaging, Process Validation, Finished-Product Testing and Batch Release in Accordance with Applicable Good Manufacturing Practice Requirements.

  2. Certificate of Registration

    ISO 9001

    Quality management

    Covers the quality management system, from development and procurement through manufacture, filling, labelling, storage and distribution, with supplier qualification and batch traceability.

    View certificate (PDF) for ISO 9001, opens in a new tab
    Standard
    ISO 9001:2026
    Certificate no.
    SWS-Q-900747
    Issued
    Valid until
    Issued by
    Certification Assurance International

    Scope, as printed

    Development, Procurement, Formulation, Manufacturing, Lyophilisation, Filling, Packaging, Labelling, Quality Assurance, Storage and Distribution of Peptide Products including Laboratory Operations, Supplier Qualification and Batch Traceability.

  3. Certificate of Compliance

    ISO/IEC 17025

    Laboratory testing

    Covers the testing of peptide raw materials and finished products in our laboratory. The scope printed on it names identity, purity, peptide content and impurity profiling by validated methods.

    View certificate (PDF) for ISO/IEC 17025, opens in a new tab
    Standard
    ISO/IEC 17025:2017
    Certificate no.
    SWS-T-170747
    Issued
    Valid until
    Issued by
    Certification Assurance International

    Scope, as printed

    Laboratory Testing and Analytical Quality Control of Peptide Raw Materials and Finished Lyophilised Peptide Products including Identity Verification, Purity Determination, Quantitative Peptide Content Analysis and Impurity Profiling using Validated Analytical Methods.

  4. Certificate of Compliance

    ISO 14644-1

    Cleanrooms

    Covers the cleanrooms where our peptides are formulated, filled, freeze-dried and sealed, including airborne particle classification, environmental monitoring and contamination control.

    View certificate (PDF) for ISO 14644-1, opens in a new tab
    Standard
    EN/ISO 14644-1:2015
    Certificate no.
    SWS-C-146747
    Issued
    Valid until
    Issued by
    Certification Assurance International

    Scope, as printed

    Controlled Cleanroom Environments for the Formulation, Aseptic Filling, Lyophilisation and Sealing of Peptide Products in Pharmaceutical Grade Vials including Airborne Particulate Cleanliness Classification, Environmental Monitoring and Contamination Control.

  5. Certificate of Compliance

    GDP

    Storage and distribution

    Covers how finished peptides are stored, handled, warehoused and distributed once they are released, including inventory management and batch traceability.

    View certificate (PDF) for GDP, opens in a new tab
    Standard
    GDP
    Certificate no.
    SWS-GDP-747
    Issued
    Valid until
    Issued by
    Certification Assurance International

    Scope, as printed

    Storage, Handling, Warehousing and Wholesale Distribution of Finished Lyophilised Peptide Products including Temperature-Controlled Logistics, Product Integrity Assurance, Inventory Management, Batch Traceability and Distribution, Quality Control in Accordance with Applicable Good Distribution Practice Requirements.

Checking a certificate

Each certificate can be confirmed with the issuer at cert-assure.com, by the QR code printed on it, or by writing to certification@cert-assure.com. Every certificate names the holder as Lyotek Labs, Switzerland Innovation Park, Lab 311-315, Hegenheimermattweg 167A, 4123 Allschwil, Switzerland.

These certificates cover the laboratory's systems: how it manufactures, tests, keeps its cleanrooms and distributes. The results for a product are on the certificate of analysis for its lot.

cert-assure.comFind a certificate of analysis