Quality System
Key Features of Quality Systems
An integrated Quality system meeting regulatory requirements to ensure Quality, Safety and Efficacy of the products
Periodical inspections of our facilities and product approvals stand as testimony of our commitment to quality.
Verticals of Quality Assurance
Verticals of Quality Control Laboratory
Quality Management System
- Our systems are build and run in compliance with the regulations/requirements for USFDA, EMA,ANVISA, CDSCO,WHO Geneva, PICS ,ICH etc.
- Our Quality System was audited by various clients & consultants to check their compliance with respect to USFDA ,ANVISA, EMA, Ukraine GMP, Oman GMP and Saudi GMP practices & Regulations.
- Presently our system ,practices approved by CSDCO and award us WHO GMP certificate.
- Our laboratory practices are certified with GLP Certifications.
- 21 CFR Compliance Online Systems for Documentation (Docuzen), Training (Eduzen)and QMS (Qualzen) make our system robust & accurate, intact.
- Team of more than 60 persons with Quality department ensure product must meet client requitements as well as applicable regulatory expectations.
- Zero Tolerance policy against Data integrity related matter.
Quality Control Laboratory
- 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
QCA Capabilities
| Sr. No. | Instrument/Equipment | Testing Capabilities |
|---|---|---|
| 1 | HPLC with UV, FLD & DAD detectors | Assay, Related substance/compounds, Purity by Size exclusion chromatography (SEC-HPLC), Identification Test, Peptide Mapping by RP-HPLC, Charge variants by WCX-HPLC, Content by RP-HPLC |
| 2 | Gas Chromatography with FID detector | Assay / Chromatographic purity, Identification test |
| 3 | Microplate reader with Absorbance, Fluorescence Luminescence | Cell based assay (Bioassay), Host cell protein, Host cell DNA, Protein A leachate |
| 4 | Gel electrophoresis apparatus | Native PAGE, SDS (Reducing and Non-reducing), Isoelectric focusing (IEF) |
| 5 | Gel Doc Imager | Native PAGE, SDS PAGE |
| 6 | Inverted microscope | Cell counting, Morphology |
| 7 | Fluorescence spectrophotometer | Binding assay |
| 8 | Thermocycler (PCR) | Identification of Mycoplasma test |
| 9 | RT-PCR | Quantification, Identification |
| 10 | Karl Fischer with auto titrator | Water content, Potentiometric Assay |
| 11 | FTIR with ATR | Identification test |
| 12 | UV-Visible spectrophotometer | Identification, Protein concentration, Assay/Purity |
| 13 | TOC analyzer | TOC in water samples, TOC in cleaning validation samples |
| 14 | Osmometer | Estimation of Osmolality |
| 15 | Liquid particle counter (Light Obscuration) | Subvisible particulate matter analysis |
| 16 | pH meter (Regular/micro probe) | Determination of pH in water samples & product samples |
| 17 | Conductivity meter | Determination of conductivity in water samples & product samples |
| 18 | Turbidity meter | Clarity of water and other samples |
| 19 | Hot air oven | Loss on drying (LOD), Total dissolved solid (TDS), Total suspended solid (TSS) |
| 20 | Muffle furnace | Residue on ignition (ROI), Loss on ignition (LOI), Total Ash, Sulphated Ash |
| 21 | Semi micro balance / Ultra micro balance | Weighing of chemicals and samples required for the analysis |
| 22 | Bursting strength apparatus | Bursting strength of packing material analysis |
| 23 | Visual inspection hood | Appearance/Description |
| 24 | Concentric water bath | Total dissolved solid, Heavy metals, Nitrates etc. |
| 25 | Thermomixer | Incubations and Mixing of samples |
| 26 | Biosafety cabinets & Laminar air flow unit | Bioassay and sample aliquotion and other sterile activities |
| 27 | Halogen moisture balance | Loss on drying / Moisture content |
| 28 | Vernier caliper | Packing material Dimensions analysis |
| 29 | CO2 incubators | Cells incubation |
| 30 | Incubators and Chambers | Sample, kit, chemical storage and stability inception |
| 31 | Cryo can (Liquid Nitrogen) | Cryopreservation of analytical cell lines |
Microbiological Laboratory
- 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
