Quality

qualityWe operate a BSI accredited ISO9001: 2008 UKAS Quality Management System (Certificate: FM 560179).  Our Quality Manager oversees all aspects of Quality Assurance including the release of starting materials, documents and labels, audit of training, procedures and processes, final product release, and audits by regulatory bodies and customers.

Operating independently from production, the QC department evaluates the integrity of the active substance. 

  • Wealth of experience in analytical techniques
  • Development and validation of analytical procedures
  • Control and release of retention samples and standards
  • Analysis of starting materials, including primary and secondary packaging
  • Continuous monitoring of the cGMP facility and storages
  • In-process and batch analysis
  • Final product analysis
  • Fully compliant ICH stability studies
  • Equipment qualification 

Critical analyses are undertaken using validated external procedures.