Quality
Quality as a culture
We uphold the highest standards of quality in everything we do, providing top quality products meeting the right regulatory requirements.
We are committed to upholding the highest standards of quality within our operations. Our Quality division is responsible for ensuring that products are compliant meets and exceed regulatory requirements.
We employ a comprehensive quality management system that begins with a thorough review of our raw materials and extends to every aspect of our manufacturing process, including design, engineering, production, and distribution.
At CTX Lifesciences, our Quality systems are based on GMP ICH Q7A guide and we are committing to continuous improvement in all aspects of our business. They work closely with our R&D and Regulatory Affairs departments to ensure that our products meet and exceed all regulatory requirements. They are committing to continuous improvement and ongoing training to stay up-to-date with the latest developments in the field.
Our Quality Assurance( QA ) department also jointly works closely with our clients and the Health Agencies to ensure that their compliance requirements are meeting expectations. We strive to see that our products consistently meet their expectations. From raw materials to finished products, our Quality Control team conducts rigorous testing and analysis to ensure that every batch of our products meets the highest standards of purity and potency. They are committing to continuous improvement and innovation, and are always looking for new ways to enhance the quality and reliability of our products.
Quality Control Lab is a well equipped 21 CFR compliant Instrumentation & Microbiology labs with various instruments.
Testing Capabilities
- API Batch Release
- Particle Size Analysis
- Solid State Characterization and Polymorph Quantification
- Stability Testing
- Microbiological Testing and Evaluation
- OVI / Residual Solvent Testing
- Raw & Packaging Material Testing
- Impurity Synthesis & Analysis
- Elemental Analysis
- Water Quality Analysis
- Mutagenic & Genotoxic Assessment and Analysis
- Nitrosamine Assessment and Analysis
- Particle Size Analysis
Quality Control
CTX has in-house all prominent analytical instruments within its Laboratories and it is complying with 21 CFR Part 11 and EUGMP Annex-11 catering to all the analytical requirements satisfying regulatory norms as well as customer expectations as well as in-house research.
Physico-Chemical Analysis Laboratory
- Ultra-High-Performance Liquid Chromatography(UHPLCs)
- High-Performance Liquid Chromatography(HPLCs)
- Auto Sampler- Gas Chromatography (AS – GC)
- Headspace-gas chromatography (HS-GC)
- Headspace-Gas Chromatography/Mass Spectrometry (HS-MS-GC)
- X-Ray Diffractometer (XRD)
- UV -Spectrophotometer
- Attenuated Total Reflection- Fourier Transform Infrared(FTIR-ATR) Spectrophotometer
- Karl Fischer Titrator
- Karl Fischer Coulometer
- Autotitrator
- Polarimeter
- Malvern Mastersizer 3000 - Dry and Wet
- Ion Chromatograph
- Inductively coupled plasma atomic emission spectroscopy( ICP OES)
- Differential scanning Calorimetry (DSC)
- Stability Chambers
Microbiology Laboratory
- Laminar air flow(LAF)
- Incubators.
- Total Organic Carbon (TOC) Analyzers
- Autoclave
- Air Sampler