Aurobindo Pharma Limited: UNIT-III

WELCOMES

Ms. Angela Glenn

Ms. Cheryl Clausen
Investigators
US Food and Drug Administration

1
 AGENDA

• Overview of the Facility

• Overview of Site Manufacturing Activities

• Organization Structure and Manpower

• Overview of the Utilities

• Overview of Quality Control

• Inspection History

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Aurobindo Pharma Ltd, Unit-III

SITE ADDRESS:
Aurobindo Pharma Limited, Unit-III,
Survey No.313 and 314,
Bachupally, Quthubullapur Mandal
Hyderabad Telangana 500090 India
(IND)

WEB SITE : www.aurobindo.com

FEI No: : 3004021229

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OVERVIEW OF THE FACILITY

We are here
Scrap
Yard

Aurohouse
Stability Dept
Production
Production Blocks Block – IV

UNIT-III
II and III Left Wing
Boiler
House

Production Block–I Production

Utility
and Block – IV

Warehouse
Quality Control Lab Right Wing

Central
FG
APL Research Centre I

Genera
tor
Warehouse,
Canteen
Water
Pre-
treatm
ent

and Offices
Plant

Admin &
Security
Building

Main Gate

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OVERVIEW OF THE FACILITY

 A Multi product Oral Dosage Forms (Non - Cephalosporin and Non Beta - Lactum)
facility.
 Commissioned in the year of 2000.
 Total area of the site is 12.5 acre and built-up area is 46360 sq.mt.
 The site has 4 blocks.
 Production Block – I (PB-I):
 PB-I built with modular concept with 3 separate manufacturing areas
(Modules A, B and C).
 Module A: Pellets / Capsules formulation.
 Module B and Module C: Uncoated / Coated tablet formulation.
 Ten blister packing lines available
 Production Block – II (PB-II):
 Designed for tablets/capsules manufacturing and packing.
 Three blister packing and one bulk packing lines are available.
 Production Block – III (PB-III):
 Designed for tablets manufacturing and packing-Dedicated for Finasteride Tablets.
 Bottle packing and blister packing lines are available.
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OVERVIEW OF THE FACILITY

 Production Block – IV (PB-IV):

 Production Block - IV is a four-storied building containing facility for manufacturing of
 Solid orals (tablets/capsules).
 Liquid orals (syrup & suspensions).
 Dry Syrups and Pellets.

 Ground Floor:
RM Stores and Packing Facility. 3 blister packing, 5 bottle packing and 1 pouch packing
lines available.

 First Floor:
Liquid and Dry Syrup filling, capsule filling, tablet compression and coating areas.

 Second Floor:
Liquid, Dry syrup, Pellets manufacturing, Granulation and blending areas.

 Third Floor:
Technical Area

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OVERVIEW OF THE SITE MANUFACTURING ACTIVITIES

Production Area Dosage Form

PRODUCTION BLOCK - I TABLETS / CAPSULES (PELLETS)

PRODUCTION BLOCK – II TABLETS / CAPSULES

PRODUCTION BLOCK – III TABLETS

PRODUCTION BLOCK - IV TABLETS / CAPSULES / LIQUIDS / PFOS

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ORGANIZATION STRUCTURE

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MAN POWER

S. No. Department No. of Personnel

1 Operations 02
2 Production 812
3 Quality Assurance 149
4 Quality Control 264
5 Engineering 95
6 Stores 72
7 Safety 04
Process Development and
8 06
Technology Transfer
9 Information Systems 01
10 HR and Administration 12
TOTAL 1417

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OVERVIEW OF THE UTILITIES

 Purified Water:
 Two Purified Water systems with generation capacity of 0.6KL per hr and 5KL
per hr.
 Purified water is generated through double pass RO, EDI and UF.
 The purified water meets USP/EP specifications.
 Compressed Air:
 Oil free air compressor with capacity of 4104 CFM is available.
 All critical user points are provided with 0.2µ terminal hydrophobic filter .
 HVAC:
 189 Air Handling Units are used to maintain the temperature, Relative
humidity, differential pressures and required cleanliness air.
 All critical manufacturing areas provided with Plenum and Terminal HEPA
filters.
 Power Back-up:
 12 power generators with total capacity of 10250 KV are available.

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 OVERVIEW OF QUALITY CONTROL

 A dedicated/self contained Quality Control Laboratory for chemical,

Instrumentation and Microbiological for testing of Raw Materials,
Packaging Materials, In-process and Finished Products.

 Laboratory Information Management System (LIMS) is in place for

handling of laboratory activities.
 Instrumentation Laboratory is equipped with major equipment like.
 HPLCs
 Head Space Gas Chromatography
 UV-VIS Spectrophotometer
 FTIR
 FT NIR
 Particle size analyzer
 Differential Scanning Calorimeter
 XRD
 Polarimeter (Digital)
 ICPMS

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INSPECTION HISTORY

S. No. Name of the Authority No.of Inspections Recent Inspection Date

1 US FDA 8 Jan 2016

2 EU 7 Oct 2016
3 ANVISA 4 Feb 2009
4 WHO 4 Aug 2009
5 TGA (Australia) 1 Nov 2008

Other Accreditations:
Health Canada, TFDA (Taiwan), Turkey, KFDA (Korea), GCC, MCA-Zimbabwe,
MCC-South Africa, Ministry Of Health Kenya, NAFDAC (Nigeria), Ministry of
Health Sudan, Ministry of Health Tanzania, Drug Regulatory Unit-Republic of
Botswana, DACA-Ethiopia, Ministry of Health Ukraine, Ministry of Health
Byelorussian, NDA-Uganda.

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Thank you

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