overview - pharmacompass · name designation qualification responsibility experience ... blister...
TRANSCRIPT
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OVERVIEW
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COMPANY OVERVIEW
Global Pharmatech started as a specialized Sterile Liquid Injection manufacturing company in 1996.
Manufacturer of a wide range of products across various therapeutic segments.
Total plant area of 5 acres is located in Hosur, Tamil Nadu (outskirts of Bangalore).
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VISION
“To be recognized as a world class manufacturer of pharmaceutical formulations
and create value for our business partners and stakeholders through continuous
improvement and innovation to improve Quality of Life”.
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We are committed to comply with customer requirements and with all applicable regulations,
and to ensuring product quality, safety and efficacy.
To achieve this goal, we shall maintain and continually improve the
effectiveness of our Quality Management System.
QUALITY POLICY
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WHO GMP: Valid up to 31.12.2015
NAFDAC: Approved in Sept 2014
DPM: GMP from Cote d’Ivoire
EU GMP compliant: Under Renewal
ISO 9001:2008: Valid up to 28.05.2016
ISO 13485:2003: Valid up to 28.05.2016
Periodically audited by GSK, PMS Canada and our other customers.
APPROVALS
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Health Canada Audit – 17 to 23 Sept 2015
EU GMP - Hungary (PICS) – 11 to 15 Jan 2016
MOH- Malaysia (PICS) – Q4 2015
MCC – South Africa – SMF accepted
Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA) – awaiting audit schedule
TGA / TFDA / NDA will be triggered soon
IMPORTANT AUDITS - TRIGGERED
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SITE LAYOUT
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Mr. T. Thomas
Chairman
Dr. Bhaskar Krishna
Managing Director
ORGANIZATION STRUCTURE
Operation Mr. Arul Prasadh
Quality operation Mr. Chezhian
Supply Chain Mr. Viswanathan R&D
Business Development Mr. Deepak Vagale
Finance & HR Mr. Hegde
Production Mr. Chandran
Instrumentation Mrs. Sumathi
Microbiology Mr. Shyam
Quality Assurance Mr. Sethurajan G
FR&D Mr. Raja G
AR&D Mr. Karthik N
Regulatory Mrs. Sindhu Hari
Engineering
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MANAGEMENT TEAM
Name Designation Qualification Responsibility Experience
Dr. BHASKAR KRISHNA Managing Director PhD, MBA General Management 19 Yrs.
SHIVANANDA HEGDE Chief Finance Controller FCA, ACS Finance, Accounts & HR 16 Yrs.
S. ARUL PRASADH DGM Operation B.Pharm., MS Head of Production &
Engineering 17 Yrs.
S. CHEZHIAN DGM – Q.O. M.Sc. Quality Operation 20 Yrs.
A.VISWANATHAN DGM-Supply Chain B.Sc. MBA Supply Chain Management 25 Yrs.
DEEPAK VAGALE DGM – Business Development
B.Sc., D. Pharm Business Development 20 Yrs.
SINDHU HARI DGM – Regulatory B.Sc., Diploma in Regulatory
Regulatory Affairs 20 Yrs
G. RAJA Sr. Manager – FR&D B.Pharm., MS Formulation Department 14 Yrs.
N. KARTHIK Sr. Manager – AR&D M.Sc Analytical Development 9 Yrs
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TOTAL EMPLOYEES- 221
Department Staff Workmen Total
Quality Assurance 15 01 16
Quality Control 24 03 27
Production 24 102 126
Stores and Distribution 10 04 14
Technical, Engineering, and other support services, FR&D/AR&D, Regulatory Affairs
28 25 53
Total 101 135 236
EMPLOYEE STRENGTH
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QUARANTINE (AMBIENT) 70 sq.mt (with multi level storage racks)
QUARANTINE (BELOW 25O C) 30 sq.mt (with multi level storage racks)
APPROVED MATL (BELOW 25OC) 130 sq.mt (with multi level storage racks)
RAW MATERIAL WAREHOUSE
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Dedicated sampling booths and dispensing booths with RLAF under Class D area
SAMPLING AND DISPENSING
SAMPLING DISPENSING
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Integrated Washing, Sterilization, and Filling line
Terminal Sterilizer in place
Aseptically filtered with 0.2 micron filters
Fill volume: 1mL to 10mL
Batch size: 100 liters to 400 liters
Speed: 250 Ampoules/minute
Annual Capacity: 72 million Ampoules
AMPOULE LINE
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Integrated Washing, Sterilization and Filling line
Aseptically filtered with 0.2 micron filters
Batch size: 100 liters to 400 liters
Fill volume: 2mL to 100mL
Speed:150 vials / minute
Annual Capacity: 36 million vials
VIAL LINE
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100% visual inspection of all filled containers.
Visual inspection conducted manually and with semi automatic inspection machines by trained and qualified personnel by validated method.
Visual inspection designed to remove all
defective containers.
INSPECTION
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CAPACITY Ampoules: 250,000 per shift
Vials: 100,000 per shift
BLISTER MACHINES Form Pack: 400 Ampoules / minute
Rapid Pack: 400 Ampoules / minute
PACKING Blisters and Vials manually packed in cartons
QUALITY In process check carried out to eliminate packing errors
PACKING
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AMBIENT TEMPERATURE : Storage area of 125 sq.mt TEMPERATURE BELOW 25O C : Storage area of 150 sq.mt
FINISHED GOODS WAREHOUSE
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• Total 22 AHUs to provide clean air as per criticality of the process
• Separate Air Handling Units with HEPA filters are installed at each processing room.
• Aseptic area temperature is maintained between 18°C to 25°C and Relative Humidity (RH) is maintained between 40% to 60%. Temperature of storage areas is maintained based on material or product requirements.
• The entire plant is maintained at a positive differential pressure with respect to the external atmosphere.
• A minimum pressure differential of 1.6mm/16 Pascal's is maintained between two different classified areas and positive pressure is maintained from critical to non critical rooms of the same classification
• All AHUs are designed to have sufficient air-changes with 10% fresh air intake during each cycle.
• Filling room Air Changes is NLT 70 ACPH
Air Handling Unit
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• Grade-A (Filling) is provided by laminar airflow stations, HEPA of 99.999% efficiency and is surrounded by Grade-B
• Grade-B ( Back ground of Filling): 20 micron, 10 micron, 5 micron, 0.3 micron plenum HEPA of 99.997% and 0.3 micron with terminal HEPA of 99.999% efficiency is series
• Grade-C (Compounding): 20 micron, 10 micron, 5 micron, 0.3 micron plenum HEPA of 99.997% and 0.3 micron with terminal HEPA of 99.997% efficiency is series
• Grade-C (Washing): 20 micron, 10 micron, 5 micron with plenum HEPA of 99.997% efficiency
Classification of Manufacturing Areas
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Utilities: Water System
• Purified Water – RO/EDI system
– Capacity: 5000 liters/hr
• Water for Injection (WFI) – Multi-column evaporator with continuous circulation loop with WFI at
> 80°C.
– Capacity: 1500 liters/hr
• Pure Steam – Capacity: 300 kilograms/hr
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Utilities: Other
• Raw Steam – 2 MT briquette boiler
– 800 KG standby diesel boiler
• Electricity – Sanctioned load of 950 KVA supplied by State Electricity Board
– Full Diesel Generator backup (500 KVA, 380 KVA, 250 KVA)
• Cooling – 250 TR Vapour Absorption Machine
– Backup Screw Chillers (150 TR and 45 TR)
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Utilities: Other
• Compressed Air – Capacity: 300 CFM
• Nitrogen – Capacity: 25 Nm3/hr
– Complies with EP and USP
• Effluent Treat Plant – Onsite Zero Liquid Discharge (ZLD)
– Sewage Treatment Plant (STP)
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QUALITY
• Global Pharmatech’s strength is providing products of the highest quality.
• In keeping with the requirements of our customers, the quality assurance department adopts the best of procedures and practices.
• The plant is scrupulously operated through built-in rigorous Quality Assurance procedures, strict documentation and internal audits.
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QUALITY CONTROL INSTRUMENTS
UV Spectrophotometer HPLC with Auto sampler Liquid Particle counter
Micro Balance IR Spectrophotometer Mini API Analyzer
Atomic Absorption Spectrophotometer (AAS)
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RESEARCH AND DEVELOPMENT
• Formulation R&D
– Develop solution formulations in vials and ampoules
– Enhancing capability to develop emulsions, suspensions, and DEPO products
– Will acquire capability to develop lyophilization products
• Tech Transfer
– Experienced with good project management
• Analytical R&D
– Responsible for Method Development and validation
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LYOPHILIZATION
• New Capability for Global Pharmatech
• To be constructed by incorporating part of Unit 1 into Unit 2 – Vial line: 200 vpm
– Lyo Chamber: 8.6 m2
• Expected to complete by next 15 to 18 months
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Climatic Zone Zone Temperature Humidity
Real Time II 25 ºC ± 2 ºC 60% RH ± 5% RH
Real Time IV a 30 ºC ± 2 ºC 65% RH ± 5% RH
Real Time IV b 30 ºC ± 2 ºC 75% RH ± 5% RH
Real Time (under installation)
Cold Chain 5 ºC ± 3 ºC -
Accelerated - 40 ºC ± 2 ºC 75% RH ± 5% RH
STABILITY CHAMBERS
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PRODUCTS REGISTERED
Product Country
Promethazine Hcl 2 mL Ampoule Algeria
PRODUCT REGISTRATION
PRODUCTS UNDER REGISTRATION
ASIA AFRICA LATAM
Philippines Nigeria, Cote d’Ivoire Dominican Republic
Vietnam South Africa, Namibia, Zambia Jamaica
Malaysia Togo, Burkina Faso, Senegal, Mali Peru
Myanmar Ethiopia, Kenya, Tanzania, Uganda
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THANK YOU