Biotechpharma Quality Control Sector employees are committed to excellence through quality by experience and expertise in pharmaceutical industry and continuous training.
Quality Control in Biotechpharma covers testing of biotechnology products to verify that their structure meets predefined criteria related to safety, stability and efficacy in the final product formulation. Biotechpharma uses a variety of state-of-the-art techniques to demonstrate both physical and chemical characteristics of biotechnology products. Quality Control also supports GMP production by environmental monitoring and process control.
Main Quality Control services:
- Ensure the quality of a company's products or services.
- Preparation of specifications, SOPs, sampling, testing and documentation of all incoming starting materials, active pharmaceutical ingredients, drug products.
- Implementation, qualification/validation of analytical methods (ICH) used for characterization and control of cell banks, raw materials, active pharmaceutical ingredients, drug products.
- Performance of quality control testing of cell banks, raw materials, active pharmaceutical ingredients (API) and drug products (DP).
- Management of reference standards, retention samples, analytical (assay) cell banks used for drug substance and drug product analysis
- Management of stability programs (real-time, stressed, accelerated).
- Preparation and execution of the environmental/critical systems monitoring programs
- Performance of process validation support testing