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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.

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

Management Team
Over 30 years experience in the pharmaceuticals industry

Mr. Suresh Khanna


Chairman

Mr. Vijay Kumar


Ranka
Director - Operations

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

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.

Dr.Kishore Shenoy
Vice President Operations

Mr. Manohar H
Urankar
Associate Vice
President-FR&D

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
Excellent knowledge of the principles, policies, practices, procedures, and strategies
required in the development of pharmaceutical dosage forms like Oral solids,
Capsules (Hard & Soft gelatin), Semisolids, Oral care products.
Experienced in Pharmaceutical Formulation Development & Manufacturing in
reputed companies like Strides Arcolab, Kemwell Biopharma, Alkem Labs, Gufic etc.
Proficient in development of formulations for various regulated countries.

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

Regulatory Compliance Status

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

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

Lab Approval Clarification TGA


Guidelines
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

these laboratories do not necessarily have to


be TGA approved. Other certificates may be used in lieu of a GMP
parties,

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

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

Lab Approval Clarification MHRA


Office

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

Lab Approval Clarification IMB Office

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

Quality Management System


WHO
cGLP / cGMP
21 CFR Part
210 / 211

ISO /IEC
17025
Quality
Manual

Quality
System / Assurance
Procedures
Standard Operating
Procedures

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

Stabicon Life Sciences


A partner for all your analytical needs

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

Stabicon Life Sciences


A partner for all your analytical needs

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

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

11

Product Development - Highlights

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

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

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

13

Formulation Services Offered


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

14

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
System

Access Control Systems

Purification

Fire Alarm Systems


Smoke Detection Systems
Stabicon Life Sciences
A partner for all your analytical needs

Sep 2013

15

Analytical Services Offered


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

16

Stability Programs

Long-term Stability Studies


Accelerated Studies
Photo-stability Testing

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

Chambers & Software


Qualified as per
21 CFR part 11, ICH
&
GAMP-V
Guidelines

Current Capacity
55,000 Liters
Scalable to
200,000 liters
To accommodate
6000 to 25000
Batches

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

17

Stability Programs
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

18

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
Dissolution
Uniformity of Content
Related Substances
Degradation Products

Identification
Purity
Preservatives
Anti-oxidants
Colourants

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

19

Biowaiver Studies

Development
of
Dissolution Methods

Discriminating

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

20

Pre-Despatch QC 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

Sep 2013

21

Microbiology

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

22

Laboratory Operation Process


Samples

Sample
Registration

QC
Manager

Issue of Analytical
Work Plan

Allottment of Samples
to Analysts

Customer

Contract / Order / Samples

Proposal / Invoice

Contract / Order

Customer
Relations
Management
CoA / Test
Report

CoA / Test Reports

Technical
Communications

Analysts

Archival

Execution of Analysis &


Data Generation

Analytical Reports & Raw data


Residual Samples

QA
Manager

Stabicon Life Sciences


A partner for all your analytical needs

Reviewed raw data

QA

Analytical Data
Review Team (QA)

QC

Project
Team

Sep 2013

23

Clientele

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 MNCs for Method Validation and
Stability Studies for their International markets

Stabicon Life Sciences


A partner for all your analytical needs

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

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

26

Website

For detailed information & RFQ, please visit our website

www.stabicon.com

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

27

Thanks
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 : info@stabicon.com

Stabicon Life Sciences


A partner for all your analytical needs

Sep 2013

28

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