While some activities are interrelated, Quality Assurance and Quality Control are two aspects of quality management and within the company, two different teams assure that quality assurance and quality control responsibilities are fulfilled.
Quality Assurance (QA) unit works to establish procedures and quality systems, ensuring that manufacturing processes comply with standards at both national and international level and that manufactured drug products comply with Good Manufacturing Practice (GMP) regulations. QA unit implements process improvements whenever possible and leads efforts to investigate, correct, and prevent any quality issues that have occurred. QA responsibilities include the following:
- Change control management
- Corrective action / preventive action (CAPA)
- Deviation management
- Document control
- Bulk and Finished product release
- Customer complaints
- Internal and external quality audits
- Internal training of employees
- Quality trending, record control, and system management review
- Supplier evaluation and monitoring.
Quality control laboratory performs analytical services, starting from product development activities and ending with finished products quality control.
The laboratory is fitted with equipment designed to test:
- Incoming products both raw materials and goods
- Samples of control process
- Finished products
Laboratory performs physical, chemical and microbiological analysis, as well as method development and validation. All analyses are performed in accordance with Good Manufacturing Practice (GMP) regulations and ICH guidelines.
Quality control laboratory collaborates with foreign clients, performing various type of analysis. Our laboratory has been successfully passed several inspections, including EU, Korea, Russia and Turkey audits.
Laboratory is fitted with equipment including, but not limited to the following:
- High Performance Liquid Chromatography (HPLC) devices
- Particles Measuring System in liquid
- KF titrators (volumetric and coulometric)
- UV/VIS Spectrophotometer
Moreover, on the premises of quality control laboratory it is possible to perform microbiological environmental monitoring, bioburden and sterility analysis.