Quality as a system principle

Cleanroom production, structured QC/QA processes and project-specific documentation form the basis of our quality system.

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Quality through process and certification

At ALGENE, quality is not created only at the end of production. It is managed systematically through a defined process architecture, digital data capture and clear release mechanisms. Batch-level traceability, documented procedures and project-specific specifications form the basis for traceable quality.

ALGENE is the first microalgae producer in Europe to be GMP cosmetics process-certified. The certificate assesses and confirms our reproducible production process – independently audited and awarded according to DIN EN ISO 22716. The certificate can be viewed on request and is provided with the shipment of the first sample batches.

Quality framework

  • controlled cleanroom production according to GMP cosmetics standards
  • closed production systems for defined process conditions
  • structured standard operating procedures (SOPs)
  • documented change control process

Process monitoring

  • monitoring of selected process parameters
  • digital documentation of relevant production data
  • batch-level traceability
  • support for reproducible production conditions

Analytics & release

  • scope of testing and release according to the individual supply agreement
  • CoAs can be provided per project and per batch
  • additional analytics depending on target application and agreement
  • unique batch ID according to project and delivery model

Audit & documentation

Transparency and auditability are part of our quality architecture. In addition to product- and project-related data, structured documentation modules can be provided to support our partners’ internal quality systems.

On request and as agreed, we provide:

  • cleanroom monitoring summaries
  • SOP summaries
  • batch-specific documentation
  • CoAs and test reports, where agreed per project
  • support with internal or external audit processes