Stabicon

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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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



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



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.”



Lab Approval Clarification – TGA

Office

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Lab Approval Clarification – MHRA

Office

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Lab Approval Clarification – IMB Office

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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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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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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



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



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



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



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



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



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



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



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..



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



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



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,



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



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



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



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



Website

For detailed information & RFQ, please visit our website

www.stabicon.com

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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]

Stabicon

Technology

analytical needssep

analytical development

old facility

quality management system

health canada

past experience

regulatory approvals

quality operations