Stabicon

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Stabicon

  1. 1. Overview● Located in Bangalore with built-up area of about 15000sqft Dedicated cGMP and cGLP Compliance Laboratory● Commenced operations in October 2010● Approved Testing Laboratory by Indian FDA● Managed by well experienced professionals with proven track record with Multinational Companies and Contract Testing Laboratories● In the business of Analytical Development, Validation & Stability management Programs. Stabicon Life Sciences A partner for all your analytical needs Nov 2011 2
  2. 2. Management Team Over 30 years experience in the pharmaceuticals industry Set-up one of the largest contract manufacturing company in IndiaMr. Suresh Khanna and catering to customers like GSK Pharma, GSK Consumer, Chairman Novartis, J&J, Pfizer, Wyeth, etc….. Former member of the board of Millipore India Founder of KPO providing back-office regulatory services to MNC’s in Europe Mr. Vijay Kumar Worked in area of transgenic using Micro-injection, Data curation in disease pathway identification, Bio-analysis, Impurity identification, Ranka Metabolite identification, Enzyme based assays, Characterization ofDirector - Operations biopharmaceuticals and Herbals marker identification, Past positions at NCBS, Jubilant Biosys, Synchron Research and Waters Corporation. He comes with enriched experience of about 20 years in the area ofMr. M. Venkateswarlu Pharmaceutical Development, Analytical and Quality operations.President - Operations Past positions held as Director for Life Sciences Division of SGS, and worked with major Pharmaceutical companies like Dr. Reddy’s Labs (DRL), Micro Labs Ltd., Hikal Ltd…. Stabicon Life Sciences A partner for all your analytical needs Nov 2011 3
  3. 3. Regulatory Compliance● Oct 2010 – Approved by Indian FDA as Contract Testing Laboratory● Jan 2011 – Completed the audit & Accepted by Health Canada on behalf of our Client● Mar 2011 – Registered with & Consent for Operations - by Karnataka State Pollution Control Board, India● Oct 2011 – Submission of LIF (LIF No.: L 1108) to WHO, Geneva; under Prequalification Medicine Program – Procedure for Assessing the Acceptability, in Principle of QC Laboratory for use by UN agenciesWe are in the process of accreditation fromNABLWHOUSFDA Stabicon Life Sciences A partner for all your analytical needs Nov 2011 4
  4. 4. Quality Management System WHOcGLP / cGMP ISO 1702521 CFR Part 210 / 211 Quality ● Quality Manual (QM) based on Manual ♦ ISO 17025 : 2005 ♦ WHO GPCL Quality ♦ USFDA 21 CFR Part 210 / 211 System / Assurance ♦ MHRA / EMEA Procedures ♦ Our Quality strategies Standard Operating ♦ Our Businesses Process Procedures Stabicon Life Sciences A partner for all your analytical needs Nov 2011 5
  5. 5. Organogram ManagementBusiness Development Accounts / Admin Team Project Management & Quality Assurance Customer Relation Quality Control Laboratory Department Management Chemical Sample QMS & Microbiology Registration & Instrumen- Lab Data Regulatory Customer tation Review Compliance Project Sample Relation & Management ArchivalManagement Issue of Customer COA Complaints Support Functions Data & Archival Investigations Stabicon Life Sciences A partner for all your analytical needs Nov 2011 6
  6. 6. Facility HighlightsIndependent Segregated facilities for Dedicated space Captive building, Fully Compliant Instrumentation, for Power with Pollution 5 levels, Stability Project Generation Control & EHS15,000 sq. ft. Wet Chemistry Management Regulations & &Built-up area Microbiology. Support Stabicon Life Sciences A partner for all your analytical needs Nov 2011 7
  7. 7. Laboratory Highlights● Stability Projects are monitored & maintained using Validated LIMS Software● HPLCs are on Empower Net-working Software in compliance with 21 CFR Part 11● Stability Chambers & Incubators Data Monitoring using validated ICDAS Software● All Analytical Equipment data back-up done periodically on Dedicated Server● RO Water Purification System● Access Control Systems● Fire Alarm Systems● Smoke Detection Systems Stabicon Life Sciences A partner for all your analytical needs Nov 2011 8
  8. 8. Services OfferedCORE ANALYTICAL SERVICES● Stability Programs● Analytical Development & Validation● Bio-waiver Studies (Comparative Dissolution Profiles)● Quality Control Testing● Microbiological TestingCONSULTANCY SERVICES● Regulatory Compliance Audits● 3rd Party / Vendor Audits● Facility Validation Requirements & Review● Development Activities Stabicon Life Sciences A partner for all your analytical needs Nov 2011 9
  9. 9. Stability Programs● Long-term Stability Studies ● Zone IV Conditions● Accelerated Studies ● Freeze Thaw Stability● Photo-stability Testing ● Customized Study ICH Compliant Current Capacity Storage Chambers 24/7 Chambers & Software 55,000 Liters 25 C/ 60%RH Data Monitoring, Qualified as per Scalable to 30°C/ 65%RH Mobile Alert Systems 21 CFR part 11, ICH 200,000 liters 30°C/ 75%RH & & To accommodate 40°C/ 75%RH Engineering GAMP-V 6000 to 25000 Photo-stability Team Guidelines Batches Stabicon Life Sciences A partner for all your analytical needs Nov 2011 10
  10. 10. Stability Programs We undertake Stability Programs of● R&D & Pilot Batches ● Follow-up Batches● Process Optimization Batches ● Commercial Batches● Validation Batches ● On-Going Batches Stabicon Life Sciences A partner for all your analytical needs Nov 2011 11
  11. 11. Method Development & Validation● Verification of Accuracy & Adoptability of the Developed Method● Development & Validation of Stability Indicating Methods● Analytical Method Transfers● Re-validations / Partial Validations As Per Customer Requirement● As per requirements of ICH, USFDA, MHRA, MCC, WHO, ANVISA, etc..● Method Development & Validations for ♦ Assay ♦ Identification ♦ Dissolution ♦ Purity ♦ Uniformity of Content ♦ Preservatives ♦ Related Substances ♦ Anti-oxidants ♦ Degradation Products ♦ Colourants Stabicon Life Sciences A partner for all your analytical needs Nov 2011 12
  12. 12. Biowaiver Studies● Development of Discriminating Dissolution Methods● Performing CDPs as per various Regulatory Requirements like WHO, USFDA, MHRA, TGA, MCC, ANVISA, etc…● Conclusions based on Classification of Drug Molecules● F1 / F2 calculations for acceptability of Bio-waivers Stabicon Life Sciences A partner for all your analytical needs Nov 2011 13
  13. 13. Quality Control Testing● Raw Materials (Exceipients / APIs)● Oral Solid Dosage Forms● Oral Liquid Dosage Forms● Ointments / Creams / Gels / Soft Gels● Sterile Products● Ophthalmic Products● Cosmetics Controlled By FDA● Pharmaceutical Water Analysis Stabicon Life Sciences A partner for all your analytical needs Nov 2011 14
  14. 14. Microbiology● Validation of Microbiological Tests● Qualification & Validation of Purified Water Systems● Bio-burden Tests● Sterility Testing, Bacterial Endotoxins by LAL● Antibiotic Assay● Identification of Microbial contaminant● Preservative Efficacy Testing● Efficacy Testing of Antibiotic Activity● Environmental Monitoring, Efficacy of Chemical Disinfectants Stabicon Life Sciences A partner for all your analytical needs Nov 2011 15
  15. 15. Laboratory Operation Process Samples Sample Issue of Analytical QC Registration Work Plan Manager Allottment of Samples Contract / Order / Samples to AnalystsCustomer Proposal / Invoice Customer Relations Archival Analysts Contract / Order Management CoA / Test Analytical Reports & Raw data Execution of Analysis & Report Residual Samples Data Generation CoA / Test Reports QA Reviewed raw data Analytical Data Technical Manager Review Team (QA) Communications Stabicon Life Sciences A partner for all your analytical needs Nov 2011 16
  16. 16. Bussiness Operation Process Shipment Confrimination NOC Allotment Sample Protocols Clearance from Form Shipment Customs Customer Relation Management Contract Agreements Technical / Quality NOC to ImportCustomer Agreements Samples (4-6 weeks) Facility Audit & Samples shipment details, Sample Approval Registration & Information of Damage if any Work Plan Quotation / Bid Query / RFQ / RFP CDA CoA / Test Report Review of Data & Execution of Tech. Communiq. Reporting Results Analysis Stabicon Life Sciences A partner for all your analytical needs Nov 2011 17
  17. 17. Clientele● Analytical Method Development & Validations / Stability Studies for UK, EU Countries & South Africa● Analytical Method Development & Validations / Stability Studies for Russian, CIS & Developing countries● Approved by MNC’s for International market doing Method Validation and Stability Studies● Approved by large Indian MNC’s for International market doing Method Validation and Stability Studies Stabicon Life Sciences A partner for all your analytical needs Nov 2011 18
  18. 18. Why Stabicon? Conceptualized Project Management Well Experienced Management to understand your needs during Product Development, Validations and Dossier Registration We deliver to International Standards at Local cost We not only do testing, we add value to your thought process We not only deliver reports, we be with you till you get marketing authorization as your preferred partner Open for Transparency like Data interface through Web-access Stabicon Life Sciences A partner for all your analytical needs Nov 2011 19
  19. 19. Website For detailed information & RFQ, please visit our website www.stabicon.comStabicon Life SciencesA partner for all your analytical needs Nov 2011 20
  20. 20. Thanks For any query, Please contact us at Stabicon Life Sciences Pvt. Ltd 3BM – 416, 3rd Block, HRBR Extension, Bangalore – 560 043 INDIA Phone: +91 80 4171 4280 / 81 e-mail : info@stabicon.comStabicon Life SciencesA partner for all your analytical needs Nov 2011 21

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