SGS receives WHO-PQT approval for its Navi Mumbai laboratory, bolstering support to the global pharma industry
MUMBAI, India, May 31, 2023 /PRNewswire/ -- SGS is proud to announce that it's Health Science laboratory based in Navi Mumbai has received the approval of the World Health Organization (Geneva) – Prequalification Unit (PQT) for testing, analytical services, and stability studies.
The WHO-PQT approval marks a critical advancement in the company's ability to provide unparalleled support to pharmaceutical manufacturers worldwide in the development of high-quality pharmaceutical products. SGS's Health Science laboratory in Navi Mumbai can now provide testing services, as per scope defined in the WHO Public Inspection Report, to all countries serviced by the World Health Organization.
The SGS scope of testing services includes:
- Physical and chemical analysis
- Identification tests
- Assay, impurities, and related substances
- Microbiological analysis
- Stability studies
Mr. Shashibhushan Jogani, Managing Director, SGS India expressed immense pride and appreciation for the collective efforts of the team, stating, "This is a remarkable achievement and a testament of our unwavering commitment to quality and pursuit of excellence. I am proud of the efforts of our team which has led to the successful qualification of our laboratory by the World Health Organization. This significant milestone enables us to reach out to customers worldwide and support them through the development of drug products, and help to ensure the delivery of safe, effective, and compliant medicines to global markets."
Mr. Sathananthan Sangaran, Business Director – Health & Nutrition, SGS India said, "The WHO-PQT approval is a big achievement which propels us into a new level of global engagements and partnerships with pharma companies for safe and compliant drug development in a fast and efficient manner."
Spread over 3400 m2 of built-up space, the SGS India Centre of Excellence in Navi Mumbai is a USFDA inspected facility. It is also certified for ISO 9001, ISO14001 and ISO 45001. The laboratory can undertake complex testing and analytical studies in:
- Method development & validation
- Method transfer & verification
- Analytical chemistry – batch release
- Utilities testing and monitoring (gas, air, water, surface)
- Insourcing and outsourcing solutions
- Extractables & leachables
- Stability studies & storage
- Residual solvents analysis
- Genotoxic impurities
- Cleaning validation
- Elemental impurity testing
- Particle size distribution (wet and dry)
- Admixture study (diluent compatibility)
- Microbiological testing
- Microbial limit test
- Preservative/antimicrobial efficacy test
- Bacterial endotoxin test (gel clot & KTA/KCA)
- Disinfectant efficacy studies
- Antibiotic assay
- Qualification of water system
- Qualification of sterile and non-sterile manufacturing facilities and microbiology lab
- Kill rate study
This state-of-the-art facility is equipped with high-end instruments including HRMS, LCMS/MS, GCMS/MS, ICPMS, IC HPLC, GC and is uniquely positioned to offer a broad spectrum of advanced testing and analytical services to the pharmaceutical industry and meet the growing needs of drug manufacturers.
We are SGS – the world's leading testing, inspection, and certification company. We are recognized as the global benchmark for sustainability, quality, and integrity. Our 97,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer, and more interconnected world.
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