QC/QA Services

  • Establishment, revision and maintenance of quality policy in line with GMP and ICH requirements
  • Development and implementation of quality related SOPs
  • Qualification of technological equipment, critical utility systems, manufacturing facilities as well as validation of technological processes for both APIs and FDF
  • Training of personnel on GMP related issues
  • Performance of self-inspections and auditing vendors of raw materials and quality related services
  • Preparation of Product Quality Reviews (PQR)
  • QC of raw materials, intermediates and finished products
  • Validation of analytical methods

Laboratories of QA Department are well equipped with modern analytical instruments. Among others there are following techniques:

  • HPLC (UV, MS, LSD, RI)
  • UPLC
  • GC, GC-MS
  • Particle size analysis
  • IR, UV, polarimetry
  • Dissolution analysis for FDFs
  • Automatic titration

Contacts:

Vitālijs Kiseļovs
Director of the Quality Assurance Department
Phone: (+ 371) 67 013 703
E-mail: vkiselovs@olainfarm.lv

SigitaQC/QA Services