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.
Sep 2013
Management Team
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 MNCs in Europe
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.
Dr.Kishore Shenoy
Vice President Operations
Mr. Manohar H
Urankar
Associate Vice
President-FR&D
Sep 2013
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 17025:2005
and 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
Sep 2013
Sep 2013
Sep 2013
Sep 2013
Sep 2013
ISO /IEC
17025
Quality
Manual
Quality
System / Assurance
Procedures
Standard Operating
Procedures
Sep 2013
Organogram
Management
Business
Development
Finance &
Administration
QC Laboratory
Project
Management
& CRM
Formulation
R&D
Chemical
&
Instrumentation
Microbiology
Lab
STABILITY MANAGEMENT
Quality Assurance
Sample
Registration
Sample
Archival
Data
Archival
Data
Review
&
Issue of
COA
QMS
&
Regulatory
Compliance
Customer
Complaints
&
Investigations
Sep 2013
10
Facility Highlights
Independent
building,
3 levels,
15,000 sq. ft.
Built-up area
Dedicated
Facility for
Segregated
facilities for
Captive
Formulation
Development
Instrumentation,
Power
Wet Chemistry,
(Tablets,
Capsules,
Liquid
Orals,etc..)
Generation
Microbiology.
&
Stability Project
Management
Support
Fully
Compliant
with EHS
Regulations
Sep 2013
11
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
12
Formulation Equipment
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
Sep 2013
13
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
Sep 2013
14
Laboratory Highlights
RO
Water
System
Purification
Sep 2013
15
Stability Programs
Analytical Development & Validation
Bio-waiver Studies (Comparative Dissolution Profiles)
Quality Control Testing
Microbiological Testing
Sep 2013
16
Stability Programs
ICH Compliant
Storage Chambers
25C/ 60%RH
30C/ 65%RH
30C/ 75%RH
40C/ 75%RH
Photo-stability
24/7
Data Monitoring,
Mobile Alert Systems
&
Engineering
Team
Zone IV Conditions
Freeze Thaw Stability
Customized Study
Current Capacity
55,000 Liters
Scalable to
200,000 liters
To accommodate
6000 to 25000
Batches
Sep 2013
17
Stability Programs
We undertake Stability Programs of
Follow-up Batches
Commercial Batches
On-Going Batches
Sep 2013
18
Assay
Dissolution
Uniformity of Content
Related Substances
Degradation Products
Identification
Purity
Preservatives
Anti-oxidants
Colourants
Sep 2013
19
Biowaiver Studies
Development
of
Dissolution Methods
Discriminating
Sep 2013
20
Pre-Despatch QC Testing
Sep 2013
21
Microbiology
Antibiotic Assay
Preservative Efficacy Testing
Efficacy Testing of Antibiotic Activity
Sep 2013
22
Sample
Registration
QC
Manager
Issue of Analytical
Work Plan
Allottment of Samples
to Analysts
Customer
Proposal / Invoice
Contract / Order
Customer
Relations
Management
CoA / Test
Report
Technical
Communications
Analysts
Archival
QA
Manager
QA
Analytical Data
Review Team (QA)
QC
Project
Team
Sep 2013
23
Clientele
Approved by large Indian and other MNCs for Method Validation and
Stability Studies for their International markets
Sep 2013
25
Why Stabicon ?
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
Sep 2013
26
Website
www.stabicon.com
Sep 2013
27
Thanks
For any query,
Please contact us at
Stabicon Life Sciences Pvt. Ltd
Plot No. 28,
Sep 2013
28