SGS Receives WHO-PQT Approval for Navi Mumbai Laboratory, Bolstering Support for the Global Pharma Industry

Approval marks a critical advancement in our ability to provide unparalleled support to pharmaceutical manufacturers worldwide.

SGS is proud to announce that our 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 our 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.

Our 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 team’s collective efforts, 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 have 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 Center 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 and validation
• Method transfer and verification
• Analytical chemistry – batch release
• Utilities testing and monitoring (gas, air, water, surface)
• Insourcing and outsourcing solutions
• Extractables and leachables
• Stability studies and 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 and 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.

For more information, please contact:

Hitendra Vartak
Head – Pharmaceutical Services
Health & Nutrition
t: +91 829 18 15 851