Quality System
An integrated Quality system meeting regulatory requirements to ensure Quality, Safety and Efficacy of the products
The technical team has developed systems to ensure that quality is built into the process, leading to consistency of output. Periodical inspections of our facilities and product approvals stand as testimony of our commitment to quality.
Quality Control Laboratory has multiple testing capabilities such as
- Analytical - chemical
- Molecular Biology including Mycoplasma, Virology and Bioassay.
- Microbiology
- Bio-Analytical GLP Lab for Clinical Samples.
All Labs are equipped with applicable classified areas for performing analysis. Labs is equipped with all infra-structure with sophisticated 21 CFR / CSV compliant instruments / equipment’s. Lab is fully equipped for testing and characterization including stability studies for biosimilars with all instruments / equipment’s such as HPLC, Fourier Transform Infra-Red Spectrophotometer, Gas Chromatograph, Spectrophotometer, real-time PCR, Karl Fischer Moisture Analyzer, ELISA Readers, Liquid Particle Counters, Capillary Zone Electrophoresis, Centrifuge, LAFU, heating block, Agarose electrophoresis unit and Gel doc, BSC, CO2 Incubators, Microscopes, centrifuge, Plate reader (Absorbance instruments, fluorescence) and luminescence), SDS-PAGE and several other state-of-the-art Quality control lab is equipped with qualified and dedicated stability walk in chambers for stability studies for different ICH Zone.
- -20°C
- 2-8°C
- 25°C / 60 % RH
- 40°C / 75 % RH
- Photostability
Microbiological Testing
- Designed with airlocks followed by change rooms for entering classified area from unclassified corridors.
- Dedicated area for Sterility Testing equipped with Isolator with sperate change rooms.
- Dedicated area Microbial Limit Test area and isolated Live Culture Handling Area with separate entry.
- Dedicated Sterilization and Decontamination Autoclaves.
- Microbial Identification by Vitek 2 compact System
