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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Overview
● Located in Bangalore, a Dedicated cGMP and cGLP Compliance
Laboratory
● Established in September 2010
● Approved Drugs & Pharmaceutical Facility by Indian FDA
● Approved by Health Canada in Jan 2012 for Old Facility and currently
under process for New Facility
● Registered with USFDA for Old Facility and under process for New Facility
● Managed by well experienced professionals from Multinational Companies
and Contract Testing Laboratories
● In the business of Formulation R&D, Analytical Development, Validation &
Stability Management Programs.
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Management Team
Mr. Suresh KhannaChairman
Mr. Vijay Kumar
Ranka Director - Operations
Dr.Kishore ShenoyVice President -
Operations
• Over 30 years experience in the pharmaceuticals industry
• Set-up one of the largest contract manufacturing company in India and catering to customers like GSK Pharma, GSK Consumer, 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
• Worked in area of transgenic using Micro-injection, Data curation in disease
pathway identification, Bio-analysis, Impurity identification, Metabolite identification,
Enzyme based assays, Characterization of biopharmaceuticals and Herbals
marker identification.
• Past positions at NCBS, Jubilant Biosys, Synchron Research & Waters Corporation.
• He comes with enriched experience of about 30 years in the area of
Pharmaceutical Development, Analytical and Quality operations.
• Past positions experience with major Pharmaceutical companies like Shriram Labs
, Micro Labs Ltd and NABL Technical Assessor
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Dr.MaheshFormulation - Head
•Rich experience in Pharmaceutical Technology of Current and Advance drug
formulation with Doctorate in Pharmacy.
•Past experience of 10 yrs in renowned organizations likes Alembic Ltd, Zydus Cadila, DRL, etc. Worked in R&D, and capable to formulate conventional & various
advanced dosage forms/Technologies like Tablets, Capsules, Solution, Suspension,
Pellets, Dry Powder
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Regulatory Compliance Status
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● Approved by Health Canada in Jan 2012 for Old Facility, new facility was
successfully audited in 2013 and awaiting Approval letter
● Laboratory Assessment was done by NABL (National Accreditation Board
for Testing & Calibration Laboratories) – India as per ISO / IEC 17025:2005and expecting to receive accreditation certificates by End of November
2013
● Audited by WHO, Geneva; under Prequalification Medicine Program –
Procedure for Assessing the Acceptability, in Principle of QC Laboratory for
use by UN agencies; vide LIF No.: L 1108 on 10-12 September 2013 and
awaiting for publication of Inspection Report at WHO Website by November 2013
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Lab Approval Clarification – TGA
Guidelines
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In addition to Regulatory Approvals like by Health Canada, Stabicon also
meet other regulatory requirements like
● TGA – Guidance on Release for Supply, for Medicines Manufacturers,
Clause – 6.2 of Version 1.0, June 2013; which states that “6.2 Where
studies in the on-going stability program are contracted out to third
parties, these laboratories do not necessarily have to be TGA approved. Other certificates may be used in lieu of a GMP
certification, such as a current Good Laboratory Practice (GLP) certificate or
licence issued by a regulatory authority acceptable to the TGA or a current
ISO 17025 accreditation certificate. Stability test methods used by the
laboratory should be appropriately validated and documented according to
the requirements of the PIC/S Guide to GMP. The AP (Authorized Person)
must consider this as part of release for supply.”
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Lab Approval Clarification – TGA
Office
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Lab Approval Clarification – MHRA
Office
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Lab Approval Clarification – IMB Office
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Quality Management System
● Quality Manual (QM) based on
♦ ISO 17025 : 2005
♦ WHO GPQCL
♦ USFDA 21 CFR Part 210 / 211
♦ MHRA / EMEA
♦ Division – 2 of FDR, Health Canada
♦ Our Quality Strategies
♦ Our Businesses Process
ISO /IEC 17025
Standard Operating
Procedures
WHO cGLP / cGMP 21 CFR Part
210 / 211
Quality Quality
System / AssuranceSystem / Assurance
ProceduresProcedures
Quality
Manual
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Project Management
& CRM
Formulation R&D
QC Laboratory
Chemical
& Instrumentation
STABILITY MANAGEMENT
Microbiology
Lab
Sample
Registration
Sample Archival
DataArchival
Quality Assurance
DataReview
& Issue of
COA
QMS &
Regulatory Compliance
Customer Complaints
& Investigations
Management
Business Development
Accounts & Administration
Organogram
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Facility Highlights
Independent building,
3 levels,
15,000 sq. ft.
Built-up area
Segregated facilities for
Instrumentation,
Wet Chemistry,
Microbiology.
Stability Project
Management
Dedicated Facility for
Formulation Development
(Tablets, Capsules,
Liquid Orals,etc..)
Captive
Power
Generation
&
Support
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Fully Compliant
with EHS Regulations
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Product Development - Highlights
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● Development strategy and business case
● Project Time Lines and mile stones monitoring
● Administrative licensing activities
● API / Excipient / Packing materials sourcing and vendor screening
● Non infringement for API / formulation
● Formulation trials for robust composition to understand process variables on
QbD basis.
● Scale up and process optimization and stability
● Quality risk assessment and Quality attributes
● Process Validation
● Quality dossier documents
● Customer communication and building transparency, confidence and
buoyancy
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Formulation Equipment
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State of the Art Equipment Enabling all Unit Operations
● Dispensing: Under laminar flow bench with calibrated balances
● Sifting: Vibratory sifter of 12” diameter
● Granulation: Rapid Mixer Granulator for wet granulation of 1 – 5 kg
● Drug layering: Wurster column Bottom Spray coating of pellets up to 5 kg
● Top spray: Powder coating and top spray granulation up to 5 kg
● Drying: Fluid bed drier of 5 kg capacity.
● Milling: Multi mill with capacity of 50kg/hr
● Blending: Octagonal blender of handing 2 – 10 kg
● Tabletting: 16 Station Tablet press
● Coating: Auto-coater of handing 1 – 5 kg tablets – Film coating, MR Coating & Sugar
coating
● Liquid preparation: Stirrer, Semi automatic bottle filling and capping machine
● IPQC analysis – Balances, Hardness tester, Friabilator, pH meter, Moisture balance,
DT apparatus, BD apparatus, Leak test apparatus. etc.,
● Packing: Blister packing machine
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Formulation Services Offered
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● Platform Technologies like:
� Immediate and Modified release
� Wurster Pellet coating
� Powder coating and Taste masking
� Specialized drug delivery
● Dosage forms like:
� IR/SR/ER/GR/Chewable/Orally disintegrating/Floating/Dispersible Tablets; etc.,
� Hard Gelatin Capsules
� Liquid orals for pediatrics and bulk
� Semisolid topical like Ointments and creams
● Development trials as proof per customer dossier for site transfer
● Non-infringing formulations
● Addressing of regulatory queries on product development
● Cost effective formulations and trouble shooting in developed / registered
composition
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Laboratory Highlights
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● 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 Sep 2013
Analytical Services Offered
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CORE ANALYTICAL SERVICES
● Stability Programs
● Analytical Development & Validation
● Bio-waiver Studies (Comparative Dissolution Profiles)
● Quality Control Testing
● Microbiological Testing
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Stability Programs
ICH CompliantStorage Chambers
25°C/ 60%RH30°C/ 65%RH
30°C/ 75%RH40°C/ 75%RH
Photo-stability
24/7 Data Monitoring,
Mobile Alert Systems
&Engineering
Team
Chambers & Software Qualified as per
21 CFR part 11, ICH &
GAMP-V
Guidelines
Current Capacity
55,000 Liters Scalable to
200,000 litersTo accommodate
6000 to 25000
Batches
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● Long-term Stability Studies
● Accelerated Studies
● Photo-stability Testing
● Zone IV Conditions
● Freeze Thaw Stability
● Customized Study
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Stability Programs
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We undertake Stability Programs of
● R&D & Pilot Batches
● Process Optimization Batches
● Validation Batches
● Follow-up Batches
● Commercial Batches
● On-Going Batches
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Method Development & Validation
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● Method Development & Validations for
♦ Assay
♦ Dissolution
♦ Uniformity of Content
♦ Related Substances
♦ Degradation Products
♦ Identification
♦ Purity
♦ Preservatives
♦ Anti-oxidants
♦ Colourants
● 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..
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Biowaiver Studies
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● 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 Sep 2013
Pre-Despatch QC Testing
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● 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 Sep 2013
Microbiology
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● Validation of Microbiological Tests
● Bio-burden Tests
● Bacterial Endotoxins by LAL
● Antibiotic Assay
● Preservative Efficacy Testing
● Efficacy Testing of Antibiotic Activity
● Efficacy of Chemical Disinfectants
● Environmental Monitoring,
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Laboratory Operation Process
Contract / Order
CoA / Test Reports
Proposal / Invoice Customer
Relations Management
Sample Registration
QCManager
Analytical DataReview Team (QA)
Analysts
QA Manager
SamplesIssue of Analytical
Work Plan
Allottment of Samples
to Analysts
Reviewed raw data
CoA / Test
Report
Technical
Communications
Contract / Order / Samples
Analytical Reports & Raw data
Residual Samples
Execution of Analysis &
Data Generation
Archival
23QA QCProject Team
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Business Operation Process
Execution of Analysis
Shipment Clearance from
Customs
Review of Data & Reporting Results
CoA / Test Report
Tech. Communiq.
Confrimination
Samples shipment details,
Information of Damage if any
Sample Shipment
Sample Registration &
Work Plan
Technical / Quality
Agreements
Query / RFQ / RFP
CDA
Quotation / Bid
Facility Audit & Approval
ContractAgreements
ProtocolsNOC Allotment
Form
NOC to Import Samples
(4-6 weeks)
24QA QCProject Team
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Clientele
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● Analytical Method Development & Validations / Stability Studies for
a) Highly regulated markets like USA, Canada, UK, EU Countries & South
Africa,
b) Russian, CIS, Middle East & Developing countries
● Approved by large Indian and other MNC’s for Method Validation and
Stability Studies for their International markets
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Why Stabicon ?
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� Conceptualized Project Management
� Robust Regulatory Documentation
� Assured Confidentiality on Product Technology & Data
� Well Experienced Professionals who add value to your thought process by understanding your needs during Product Development, Validations and Dossier Registration till receipt of MA
� We deliver to International Quality Standards at Competitive costs
� Open for Transparency like Data interface through Web-access
Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Website
For detailed information & RFQ, please visit our website
www.stabicon.com
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Stabicon Life Sciences
A partner for all your analytical needs Sep 2013
Thanks
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For any query,Please contact us at
Stabicon Life Sciences Pvt. Ltd
Plot No. 28,
Bommasandra Industrial Area (Sub-layout),
4th Phase, Jigani hobli, Anekal Taluk,Bangalore - 560 100 (INDIA)
Phone: +91 80 2783 9259 / 60
e-mail : [email protected]