- 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