Quality Control and Quality Assurance

Kemwell takes a multipronged approach to reinforce the Quality Systems:

• Delivering the highest quality products and services on time has been a part of Kemwell’s culture and commitment.
• Emphasis on creating a “Quality at Source” culture from the shop floor to the boardroom with our “Champions Initiative”
• Creating transparent quality metrics and review systems
• Building compliance teams and quality review teams to maintain high compliance levels and monitor for continuous improvement
• Making employees aware, providing training and discussions of audit findings of public knowledge from global health authorities

• Robust and effective Quality Management system in accordance with regulations and recommendations from USFDA, PDA, EMEA, ICH, CDSCO etc.
• Implementation of GMP in phase appropriate manner from early-stage development to commercial release.
• Robust and effective Data Integrity management covering all function across organization including Process Development.
• Four tier pyramid concepts to define approach for documentation at different levels bracketed between top management and shop floor analyst / operator.
• Quality Metrics adapted from ISPE & FDA to monitor External / Internal Quality Outcomes, Site Maturity, Lab Quality etc.
• Focus on continuous improvement with periodic update to senior management.
• Process Development is also under the umbrella of QA to ensure the required quality system during early-stage development.
• Quality system integrated with 21 CFR part 11 compliant automation tools including SAP, LIMS (Laboratory Information Management System), eLMS (Electronic Learning Management System), eWMS (Electronic Warehouse Management System)

• Management of analytical method life cycle including method transfer, qualification, validation and method monitoring.
• Characterization of analytical and manufacturing cell banks.
• Reference standard establishment and characterization
• Integrated 21 CFR part 11 compliant LIMS with all core QC aspects including analyst qualification, sample management, inventory management and stability studies.
• Impurity profiling and related force degradation studies.

• Compendial methods for parenteral i.e. Sterility, Endotoxin, Visible and subvisible particulate matter, Degree of coloration and opalescence
• Content assays by absorbance, Colorimetric and HPLC based methods
• Raw material analysis including moisture content, melting point, refractive index, FTIR and various identity and assay methods

• Management of stability studies in accordance with ICH requirement.
• Exploratory stability studies including force degradation (pH, temperature, oxidation, shear stress, Photostability etc), Freeze thaw studies, Container closure comparability studies, End of shelf-life studies, Comparative stability study with innovator product.
• Qualified and 21 CFR Part 11 compliant stability chambers-
1. Monitored on-line, connected to FEMS
2. Excursion alerts through SMS alert system
3. Redundant compressors and sensors
4. Back-up spare chambers
5. Back-up power supply
6. Proper administrative controls to avoid mix up of samples

• Transfer/optimization and validation for analytical methods including bioassays, biochemical, microbiology and HPLC based methods for more than 10 projects
• Managing more than 50 stability studies under GMP domain