Stabicon

Overview
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Located in Bangalore, a Dedicated cGMP and cGLP Compliance
Laboratory

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Established in September 2010

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Registered with USFDA for Old Facility and under process for New Facility

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In the business of Formulation R&D, Analytical Development, Validation &
Stability Management Programs.

Approved Drugs & Pharmaceutical Facility by Indian FDA
Approved by Health Canada in Jan 2012 for Old Facility and currently
under process for New Facility
Managed by well experienced professionals from Multinational Companies
and Contract Testing Laboratories

Stabicon Life Sciences
A partner for all your analytical needs

Sep 2013

2

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 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.

Dr.Kishore Shenoy
Vice President Operations

Dr.Mahesh
Formulation - Head

• 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
•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


Sep 2013

3

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

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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

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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

4

Lab Approval Clarification – TGA
Guidelines
In addition to Regulatory Approvals like by Health Canada, Stabicon also
meet other regulatory requirements like

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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.”


Sep 2013

5

Lab Approval Clarification – TGA
Office


Sep 2013

6

Lab Approval Clarification – MHRA
Office


Sep 2013

7

Lab Approval Clarification – IMB Office


Sep 2013

8

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
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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


Sep 2013

9

Organogram
Management
Business
Development

Accounts &
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,

Generation

(Tablets,
Capsules,
Liquid
Orals,etc..)

Microbiology.

&

Stability Project
Management

Support

Fully
Compliant
with EHS
Regulations


Sep 2013

11

Product Development - Highlights
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Development strategy and business case

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Scale up and process optimization and stability

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.
Quality risk assessment and Quality attributes
Process Validation
Quality dossier documents
Customer communication and building transparency, confidence and
buoyancy

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

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


Sep 2013

14

Laboratory Highlights
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Stability Projects are monitored & maintained using Validated LIMS
Software

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HPLCs are on Empower Net-working Software in compliance with
21 CFR Part 11

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Stability Chambers & Incubators Data Monitoring using validated
ICDAS Software

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All Analytical Equipment data back-up done periodically on Dedicated
Server

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RO
Water
System

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Access Control Systems

Purification

Fire Alarm Systems
Smoke Detection Systems

Sep 2013

15

Analytical Services Offered
CORE ANALYTICAL SERVICES

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Stability Programs
Analytical Development & Validation
Bio-waiver Studies (Comparative Dissolution Profiles)
Quality Control Testing
Microbiological Testing


Sep 2013

16

Stability Programs
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Long-term Stability Studies
Accelerated Studies
Photo-stability Testing

ICH Compliant
Storage Chambers
25° 60%RH
C/
30° 65%RH
C/
30° 75%RH
C/
40° 75%RH
C/
Photo-stability

24/7
Data Monitoring,
Mobile Alert Systems
&
Engineering
Team

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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


Sep 2013

17

Stability Programs
We undertake Stability Programs of

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R&D & Pilot Batches
Process Optimization Batches
Validation Batches

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Follow-up Batches
Commercial Batches
On-Going Batches


Sep 2013

18

Method Development & Validation
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Verification of Accuracy & Adoptability of the Developed Method

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Method Development & Validations for

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..

♦ Assay
♦ Dissolution
♦ Uniformity of Content
♦ Related Substances
♦ Degradation Products

♦ Identification
♦ Purity
♦ Preservatives
♦ Anti-oxidants
♦ Colourants


Sep 2013

19

Biowaiver Studies
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Development
of
Dissolution Methods

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Performing CDPs as per various
Regulatory Requirements like WHO,
USFDA, MHRA, TGA, MCC, ANVISA,
etc…

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Conclusions based on Classification
of Drug Molecules

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F1 / F2 calculations for acceptability of
Bio-waivers

Discriminating


Sep 2013

20

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


Sep 2013

21

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,


Sep 2013

22

Laboratory Operation Process
Samples

Sample
Registration

QC
Manager

Issue of Analytical
Work Plan

Allottment of Samples
to Analysts

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

Reviewed raw data

Analytical Data
Review Team (QA)


QA

QC

Project
Team

Sep 2013

23

Business Operation Process
Confrimination

Protocols

NOC Allotment
Form

Shipment
Clearance from
Customs

Sample
Shipment

Contract
Agreements
Technical /
Quality
Agreements

NOC to Import
Samples
(4-6 weeks)

Facility Audit &
Approval

Samples shipment details,
Information of Damage if any

Sample
Registration &
Work Plan

Quotation / Bid
Query /
RFQ / RFP
CDA

CoA / Test Report
Tech. Communiq.

Review of Data &
Reporting Results


QA

QC

Execution of
Analysis

Project
Team

Sep 2013

24

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

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Approved by large Indian and other MNC’s 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
We deliver to International Quality Standards at Competitive
costs
Open for Transparency like Data interface through Web-access


Sep 2013

26

Website

For detailed information & RFQ, please visit our website

www.stabicon.com


Sep 2013

27

Thanks
For any query,
Please contact us at
Stabicon Life Sciences Pvt. Ltd
Plot No. 28,

Bommasandra Industrial Area (Sublayout),
th Phase, Jigani hobli, Anekal Taluk,
4
Bangalore - 560 100 (INDIA)
Phone: +91 80 2783 9259 / 60
e-mail : info@stabicon.com


Sep 2013

28

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