Stabicon

2. 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

3. Management Team
Over 30 years experience in the pharmaceuticals industry
Set-up one of the largest contract manufacturing company in India
Mr. 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 of
Director - 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 of
Mr. 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

4. 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 agencies
We are in the process of accreditation from
NABL
WHO
USFDA
Stabicon Life Sciences
A partner for all your analytical needs Nov 2011 4

5. Quality Management System
WHO
cGLP / cGMP
ISO 17025
21 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

6. Organogram
Management
Business 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 Archival
Management Issue of Customer
COA Complaints
Support Functions Data &
Archival Investigations
Stabicon Life Sciences
A partner for all your analytical needs Nov 2011 6

7. Facility Highlights
Independent Segregated
facilities for Dedicated space Captive
building, Fully Compliant
Instrumentation, for Power with Pollution
5 levels,
Stability Project Generation Control & EHS
15,000 sq. ft. Wet Chemistry
Management Regulations
& &
Built-up area
Microbiology. Support
Stabicon Life Sciences
A partner for all your analytical needs Nov 2011 7

8. 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

9. Services Offered
CORE ANALYTICAL SERVICES
● Stability Programs
● Analytical Development & Validation
● Bio-waiver Studies (Comparative
Dissolution Profiles)
● Quality Control Testing
● Microbiological Testing
CONSULTANCY 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. Laboratory Operation Process
Samples Sample Issue of Analytical QC
Registration Work Plan Manager
Allottment of Samples
Contract / Order / Samples to Analysts
Customer
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

17. Bussiness Operation Process
Shipment
Confrimination NOC Allotment Sample
Protocols Clearance from
Form Shipment
Customs
Customer Relation Management
Contract
Agreements
Technical /
Quality NOC to Import
Customer
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

18. 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

19. 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

20. Website
For detailed information & RFQ, please visit our website
www.stabicon.com
Stabicon Life Sciences
A partner for all your analytical needs Nov 2011 20

21. 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.com
Stabicon Life Sciences
A partner for all your analytical needs Nov 2011 21