Edit
Pharmacopoeial Testing
- Analysis of Drug products and drug substances carried out Routinely as per the latest pharmacopoeia (USP, BP, EP, IP. JP) or Customer In-House procedures and specifications.
- Our Laboratory is equipped with the instrumentation meeting the 21 Part 11 requirements:
Pharmacopoeial Testing
- Raw materials and excipients are tested including the following tests:
- Identification Tests
- Organic Volatile Impurities and Residual Solvents as per USP
- Heavy metals test
- Water testing is done as per IP/USP
- Development and validation of test procedures are undertaken for Non-Pharmacopoeial raw materials and excipients.
- Note: Analytical methods are used after due verifications/validations.
Stability studies (Storage & testing)
- Our Stability studies storage consists of the following conditions
- 25°C/60% R.H: ICH long-term condition
- 30 °C/65 % RH: Intermediate ICH condition
- 40 °C/75 % RH: Accelerated ICH condition
Method Development & Validations
- We offer Analytical method development and validation services in compliance with current ICH guidelines.
- Method validations are performed for all the parameters as per ICH guidelines.
- Dedicated validation group is equipped with the following analytical techniques :
- HPLC with UV-visible/PDA/ RI Detectors
- GC with FID/TCD/ECD detectors
- Ion Chromatography, GF-AAS, ICP-OES and ICP-MS
- Method development is undertaken for :
- Assay
- Impurities
- Trace metals
- Residual solvents
Microbiology Testing
- Microbial evaluation performed as per IP / BP / EP / USP and Customer In-House methods for, Pharmaceuticals,
- Cosmetics, Disinfectants and Healthcare products.
- Antibiotics, Vitamins and Disinfectants microbial assay.
- Preservative effectiveness test
- We perform Potable water/Purified water/Process water System validation studies with respect to Microbial quality
- evaluation for the following:
- Viable aerobic bacterial count, Yeast & Moulds count, Coliforms, E.coli and any other organisms as per customer request.
- Media Growth Promotion Test
- Media growth promotion test carried out as per USP.
- Clean room area monitoring
- Air Microbial quality evaluation by Settle plate method
- Microbial quality evaluation of areas
- Surface swabs for Manufacturing facility/Equipment/ Personnel.
- Sterility testing for Injectable preparations.
- Bacterial endotoxins test
Method Development & Validations
- We offer Analytical method development and validation services in compliance with current ICH guidelines.
- Method validations are performed for all the parameters as per ICH guidelines.
- Dedicated validation group is equipped with the following analytical techniques :
- HPLC with UV-visible/PDA/ RI Detectors
- GC with FID/TCD detectors
- Ion Chromatography, GF-AAS, ICP-OES
- Method development is undertaken for :
- Assay
- Impurities
- Trace metals
- Residual solvents
Quality Management
- Independent Quality Assurance department is available and responsible for Implementation & monitoring QMS in our organization.
- Control & review of all documents
- Change control, Deviation control, Handling of OOS results
- SOP’s Management
- Equipment Qualification, calibration & Validation
- Employee training and Qualification.
- Environment and safety measures
- Handling of Quality audits
- Handling of Market complaints
- CGMP/CGLP compliance