SINGLE STOP SOLUTION FOR RESEARCH SERVICES INNOVATION IS OUR CULTURE QUALITY IN OUR GENES SIPRA LABS LIMITED
ACCREDITATIONS OF SIPRA TGA- AUSTRALIA HEALTH CANADA (HC) DRUG CONTROLLER GENERAL OF INDIA (DCGI) NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL) OECD GOOD LABORATORY PRACTICES (GLP)- (INSPECTED) USFDA (WAITING FOR RENEWAL)
Our Commitment We are committed to delight customers by providing services that excel the expectations in terms of quality, speedy delivery and competitiveness Our Vision To continuously improve our Research Services, Infrastructure, Regulatory Compliance and Customer Support
SPECTRUM OF RESEARCH SERVICES Bioequivalence / Clinical Bioavailability Research Analytical Research & Pre Clinical SIPRA Microbiology Toxicity Testing Formulation Food & Water Research & Analysis Development Medical Devices Testing 23-May-17 4
KEY ACTIVITIES OF SIPRA Structure Elucidation, SYNTHESIS Mass, CHNSO, XRD, DSC, TGA, NMR DRUG/ DEVICE Rats, Mice, Rabbits, Beagle Dogs SCREENING Organic-LC - MS/MS, GC-MS/MS, IMPURITIES Residual - GC Headspace, Inorganic - ICP-MS, AAS FORMULATION Tablets, Capsules, SR Products DEVELOPMENT Accelerated , Intermediate and STABILITY & SHELF LIFE Long Term Studies 12 Bed Facility, Continuous Monitoring, PHASE-I Metabolic, Respiratory Cardiac Laboratories PHASE-II 100 Beds Bioequivalence Center Expertise in Respiratory, Anesthesia PHASE-III tied up with 15 centers Submitted 15 Dossiers for DOSSIER South Africa and 10 in India
FIRST CHOICE ANALYTICAL cGMP COMPLIANT MORE THAN 100 LABORATORY GLOBAL QUALITY AUDITS REGULATORY PER YEAR LABORATORY A TO Z EQUIPMENT TWO DECADES OF FROM WORLD EXPERIENCE CLASS TRADERS DEDICATED TEAM CAPACITY TO TEST OF SCIENTISTS MORE THAN 10000 WITH INNOVATION SAMPLES PER AND EXPERTISE MONTH ANALYTICAL EXPERTISE LARGEST COMMERCIAL COMPLETE ANALYTICAL REGULATORY TESTING ENVIRONMENT LABORATORY SINGLE STOP INTEGRATED MORE THAN 12 SOLUTIONS FOR MASS ALL THE SPECTROMETERS ANALYTICAL TESTING NEEDS MORE THAN 150 STATE OF THE ART VALIDATED INFRASTRUCTURE GLOBAL LEADER METHODS IN ANALYTICAL TESTING
Processing Impurities Waters GC-MS/MS API 4000 LC-MS/MS IMPURITY PROFILES Solvent Impurities Inorganic Impurities GC Headspace with MS ICP-MS/MS
METHOD VALIDATION ICHQ2. • Assay method validations • Related substance validation • Residual solvents by GCMS-Head Space & GCMS/MS • Trace elements validation using ICP-MS and AAS • Validation of Dissolution methods • Qualification of Genotoxic Impurities • Validation of Polymorphic methods • Particle Size methods
MICROBIOLOGICAL STUDIES • Microbiological tests, assays as per USP, Ph. Eur, IP. Etc. • Screening of bacteria and virus • Bacterial endotoxin tests (BET) using gel clot and kinetic techniques and validation. • Sterility testing using fully automated system eliminating any chance of contamination using closed and open methods. • Validation of microbiological methods • Water (Process, Raw and Purified) analysis as per desired pharmacopoeias • Preservative efficacy testing (PET) • Antibiotic susceptibility and resistance studies • Microbial limit tests and sterility (Equinox closed system), RT – PCR studies. • Antibiotic and vitamin assays.
Crystallography Polymorphs Crystallinity XRD/Raman By XRD Liquid Born % Amorphous Particles Pore Size / Particle Pore volume Size & Shape BET method Particle Size SEM Distribution Surface Area Malvern
BIOEQUIVALENCE/BIOAVAILABILITY STUDIES • Phase I to phase IV studies • 4 Clinics with a total of 120 beds • 20 beds ICU with central online monitoring • Central Nursing station with telemetric monitoring, data recording & data retrieval • Web linking of ICU with medical experts • Bio-metric system for retrieval of data • Over 15,000 volunteer database • ICCU is equipped with ADR monitoring and reporting • Recreational area for subjects • Adoption of GLP guidelines as per ICH standards. • More than 100 Validated Methods • SAS (Ver 8.2), Pharsight WinNonlin (Ver 5.2.1) Software for bio statistics
BIOEQUIVALENCE/BIOAVAILABILITY STUDIES Equipment: LC-MS/MS (API- 4000, 3000,2000), GC MS Clarus-500, HPLCs with UV Fluorescence Detectors & Deep Freezer (-80 o C) Fully Automated Immuno & Biochemistry Analyzer ELIZA Reader, X – Ray, Hematology Analyzer Electrolyte Analyzer, Urine Chemistry Analyzer E.C.G. & Deep Freezer – 25 ± 5 o C & -75 ± 5 o C
PHASE-I FACILITY • 12 Beds ICU, 3 Beds Special Care Unit • Online monitoring of BP, ECG, Pulse, Temp. and Oxygen using Real time SCADA system • Dynamic Labs for Cardio, Respiratory and Insomnia • Central Lab for Immunology, Biochemistry, Haematology and Urine Chemistry • CFR 21 part 11 compliant software • Password protected direct access to sponsor
BIOEQUIVALENCE STUDIES DCGI approved facility Designed to meet world-class specifications Studies in strict compliance with global regulatory • PD/PK Studies • Urinary Drug Elimination studies • Drug-Food Interaction Studies • Multi Dose Studies • Multi Period Studies • Drug-Drug Interaction Studies • Cosmetic & Safety Evaluation Studies
PHASE-III CLINICAL TRIALS • Association with 15 multi specialty hospitals • Protocol design & writing expertise • NIH-USA registered Independent Ethics Committee • Regulatory Approvals • NABL approved Clinical Laboratory • Respiratory, anesthesia cosmetic trial experience • Volunteer follow up & sample collection teams
PACKAGING MATERIALS • Polyethylene Terapthalate containers (PET bottles) • Polypropylene containers • High density polyethylene containers • Polyethylene containers • Glass containers • PP closers, Rubber closers and Aluminum seals • Aluminum Foil, Blister Packing, Laminated Pouches, Corrugated boxes & Fiber Drums
PACKAGING MATERIALS PHYSICAL TESTS • Stock Load test • Description • Memory test • Dimension • Fatigue test • Brimful Capacity • Fracture test • Transparency • Friction Force test • • Color Migration Leak test • • Visual Appearance Pin Holes • Identification of Material (IR, DSC)
PACKAGING MATERIALS CHEMICAL TESTS • Acidity /Alkalinity • Chemical Resistance • Reducing Substances • Volatile Sulphides • Extraction Test
EXTRACTABLES & LEACHABLES • Heavy Metals • Trace Elements • Ammonium • Particulate Matter Counting
PACKAGING MATERIALS PERFORMANCE TESTS • Permeability • Penetrability • Self Seal Ability • Vibration Test • Drop Test • Fragmentation • Tensile Strength • Bursting Strength • Environmental Stress Crack Resistance Test (ESCR)
PRECLINICAL TOXICOLOGY SERVICES
WE OFFER TOXICITY STUDIES MEDICAL DEVICE PHARMACOKINETIC PHARMACOPOEIAL PHARMACOLOGICAL TESTING STUDIES TESTING RESEARCH CYTOTOXICITY ACUTE TOXICITY HALF LIFE BIO ASSAY ANTI INFLAMMATORY ACTIVITY SKIN IRRITATION BIO DISTRIBUTION REPEATED DOSE TOXICITY PYROGEN TESTING ANALGESIC ACTIVITY IMPLANTATION BIO AVAILABILITY DOSE INHALATION ABNORMAL TOXICITY SYSTEMIC TOXICITY CARDIOVASCULAR ACTIVITY PERMIABILITY IMMUNOGENICITY ACUTE TOXICITY SKIN SENSITIZATION DIURETIC ACTIVITY DERMAL TOXICITY PROTEIN BINDING HEAMO COMPATIBILITY BIOLOGICAL REACTIVITY EXCRETION MUTAGENECITY REPRODUCTIVE TOXICITY GENOTOXICITY AND CARCINOGENECITY METABOLISM GENO TOXICITY
MEDICAL DEVICES CYTOTOXICITY SKIN SENSITIZATION SKIN IRRITATION ACUTE SYSTEMIC TOXICITY MATERIAL MEDIATED PYROGENICITY BIO COMPATIBILITY TESTING OF CATHETERS & STENTS AS PER HAEMOCOMPATIBILITY ISO 10993 (>24h) SUB CHRONIC TOXICITY BIO COMPATIBILITY TESTING OF DELIVERY SYSTEMS AS PER ISO GENOTOXICITY 10993 (<24h) CHRONIC TOXICITY IMPLANTATION CARCINOGENICITY
BARRIER BASED ENTRY DESIGN • Man • Air Shower • Materials • Pass Box • Cages Bedding • Autoclave • Test item • Pass Box • Animals • Air Shower • Controlled Air • HEPA filter
LABORATORY EQUIPMENT S. No. NAME OF THE EQUIPMENT MAKE MODEL 1. ICP/MS/MS AGILENT TECHNOLOGIES G3271A 2. GC/MS/MS WATERS QUAPPRO 3. LC/MS/MS ABSCIEX API 6500 4. RT-PCR APPLIED BIO SYSTMES STEP ONE 5. IMMUNO CHEMISTRY ANALYZER ABBOTT AXSYM 6. 2D ELECTROPHORESIS BIORAD MINI SUB CELL GT 7. HEMATOLOGY ANALYZER (XP-100) SYSMTEX XP-100 8. BIOCHEMISTRY ANALYZER (XI-640) TRANSASIA ERBA XL-640 9. ROTARY MICROTOME LEICA RM2125RT 10. AUTOMATIC TISSUE PROCESSOR LEICA TP1020 11. PARAFFIN EMBEDDING STATION LEICA EG1150H 12. COLD PLATE LEICA EG1150C 13. ELECTRIC TISSUE FLOAT BATH LEICA TP1020 14. AUTO STAINER LEICA XL
STUDY PLAN TECHNICAL RESULTS LITERATURE REVIEW REVIEW REVIEW PROTOCOL STUDY REPORT CONDUCTION PREPARATION DESIGN REGULATORY STUDY PLAN CONCEPT DISCUSSION DISCUSSION REGULATORY BODY IAEC APPROVAL APPROVAL
QUALITY ASSURANCE REGULATORY COMPLIANCE ROBUST QUALITY MANAGEMENT SYSTEM STRINGENT QUALITY CHECKS ADHERENCE TO QUALTIY AGREEMENTS SYSTEMATIC CONTROLS ON QUALITY SYSTEMS SELF ASSESSMENT BY INTERNAL AUDITS AS PER VALIDATION PLAN COMPLIANT MANAGEMENT DEDICATED QA TEAM- QUALITY IS OUR WAY OF LIFE CUSTOMER SATISFACTION RIGHT FIRST TIME AND RIGHT EVERY TIME
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