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GMP Quality System

GMP peptide quality control laboratory with HPLC analytical testing

Quality Built Into Every Stage of Peptide Manufacturing

At 52YM, quality management is integrated throughout the peptide manufacturing process. Our quality system is designed to support controlled production, documented procedures, batch traceability and consistent quality oversight from raw material handling through final product documentation.

For research and biopharmaceutical projects, we provide manufacturing documentation and available analytical information based on product and project requirements.

Peptide manufacturing cleanroom facility at Sunone
Cleanroom facility supporting controlled peptide manufacturing and production processes at Sunone.

GMP Quality System

Our quality management framework is designed around controlled manufacturing procedures, documented workflows and batch-level traceability. Quality controls are incorporated throughout the manufacturing process to support consistency, documentation and product-specific requirements.

  • GMP Quality System
  • Manufacturing activities follow documented procedures and defined process controls designed to support consistency throughout production.
  • Batch Documentation
  • Batch-specific manufacturing and quality records provide traceability and support documentation review for individual production lots.
  • Quality Oversight
  • Quality procedures support review of production records, analytical documentation and relevant batch information before completion.
Peptide manufacturing cleanroom production process at Sunone
Cleanroom production process supporting controlled peptide manufacturing at Sunone.

Analytical Testing and Quality Control

Analytical testing provides important information for evaluating peptide identity, purity and other product-specific characteristics. Depending on the product and testing scope, available analytical documentation may include HPLC, mass spectrometry and other reported test results.

Test documentation should be reviewed together with the corresponding product and batch information.

Certificate of Analysis (COA)

Available Certificate of Analysis documentation provides batch-specific analytical information for applicable products. COA records may include product identification, batch information, tested quantity, purity and other laboratory-reported results.

View Certificate of Analysis

Batch Documentation and Traceability

Clear batch documentation supports traceability throughout the manufacturing workflow. Product and batch records can be maintained alongside available analytical documentation to provide a structured record for quality review and project requirements.

  • Production Records
  • Documented manufacturing information associated with individual production batches.
  • Analytical Records
  • Available laboratory-reported analytical results linked to the corresponding product and batch.
  • COA Documentation
  • Certificate of Analysis documentation presenting available batch-specific test information.

Sample

BPC-157 HPLC chromatogram for purity analysis
HPLC chromatogram showing reported purity analysis for BPC-157.

Quality Documentation for Your Peptide Project

Need product-specific documentation or information about our peptide manufacturing capabilities? Contact 52YM to discuss your project requirements, available analytical documentation and manufacturing support.

Apenas para uso em pesquisa e fabricação. Os produtos são fornecidos a empresas qualificadas em conformidade com as leis e regulamentos do país de destino. Não se destinam a uso pessoal, diagnóstico ou terapêutico, salvo se devidamente registrados e autorizados.