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GMP analytical testing
GMP Analytical Testing
Mavens BioPharma Product Testing is a global leader in bio/pharma laboratory services, delivering comprehensive, innovative, and fast solutions for the world’s leading pharmaceutical and biopharmaceutical firms. Mavens BioPharma Product Testing’s 38 labs in 19 countries provide the world’s most comprehensive range of harmonised GMP testing services and seamless regulatory acceptance, from starting materials to finished product testing.
Mavens GMP Analytical Testing provides analytical testing and validation services to the pharmaceutical industry in collaboration with Mavens BioPharma Product Testing, India, a cGMP-compliant and US-FDA inspected facility with NAI (ZERO 483). The institution operates out of a location near Chennai’s airport. The GMP Analytical Testing facility was established to share experience with the pharmaceutical community to support projects from the laboratory to the marketplace, with more than 100 man years of cGMP analytical service in premier pharmaceutical firms in India and the United States.
The testing center offers pharmaceutical companies analytical testing and validation services. Method development and validation, raw material testing, intermediate testing, and product release testing are some of the services offered.
Services:
Various chromatographic and spectroscopic techniques are handled by the analytical team.
The pharmaceutical industry is served by the following activities.
Mavens BPT, India’s current services for drug substance, drug product, intermediates, and excipients.
- Elemental impurities evaluation as per ICH Q3D
- Genotoxic impurities evaluation as per ICH M7
- Nitrosamine impurities evaluation in drug substance and drug product
- HPLC/GC method development, feasibility, optimization, verification, validation and transfer
- Release Testing
- DS/DP analysis as per monograph
- Raw material analysis
Extension of Services from Q1 2022:
- Extractable & Leachable
- Stability Storage/Studies
- Packing material analysis
- Gel Permeation Chromatography
- Residual solvents evaluation
- Forced degradation studies
Equipment:
- High Performance Liquid Chromatography (HPLC) equipped with diode array, variable wavelength, and refractive index detector
- Gas Chromatography
- Liquid chromatographic-mass spectrometry (LC-MS/MS)
- Inductively coupled plasma-mass-spectrometry (ICP-MS)
- Gas Chromatography Mass spectrometry (GC-MS/MS)
Quality Training Experience:
Through our e-Audit portals, you may verify SOPs, procedures, reports, quality data, and policies from the comfort of your own home. We are also delighted to welcome you to our facility at pre-arranged times.
Quality System:
- Organogram & Job Responsibilities
- List of SOPs and individual SOPs
- List of Equipment/Instruments
- Instrument Qualifications
- Document Control and issuance
- Change management
- Handling of deviations, CAPA and investigations
- Individual Deviations and OOS
- Validation Master Plan
- Sample testing and release
- Computerized system validation, electronic data control and backup
- Waste handling and material destruction
- Calibration and preventive maintenance program
- Training and analyst qualification program
- Analytical method validation/transfers
- Laboratory OOS / OOT
Laboratory Data:
The following data are captured online meeting 21CFR Part 11:
- Sample receipt, storage, and tracking
- Sample preparation
- Analysis raw data
- Reports
- Analytical methods
- Instrument logs
- Temperature logs
- Room logs
- Reference standard inventory and use log
- Chemicals inventory
- HPLC column inventory log and use log