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encore healthcare pvt.ltd.
encore
WELCOMES
Mr. Shivprasad Nikam
GSK
04/06/2013
encore group
Promoters:
Sudhir Merchant
&
Viren Merchant
encore
Brief Information of the Site
encore is promoted by encore Group of Companies. encore group is
having four different manufacturing site engaged in manufacturing of
API and intermediate & Pharmaceutical formulations like tablet,
capsule, liquid orals & external preparations like creams & ointments.
encore group has about 15 years of wide experience in the field of
manufacturing and marketing of Bulk drugs and Pharmaceuticals.
The registered office of encore group is situated at 405 – 408,
Navbharat Estate, ‘B’ Wing, 172 Zakeria Bunder Road, Sewri, West,
Mumbai – 400 015.
encore healthcare Pvt. Ltd. is pharmaceutical formulations
manufacturing facility at MIDC, Paithan, Aurangabad. Site was
constructed by May & Baker in the year 1985. May & Baker
merged into Rhone-Poulenc and sold it to Nicholas Piramal in the
year 2001. encore group acquired the site from Nicholas Piramal
in March 2002. Plant was MCA Accreditation until 1994.
The site has been supplied by MIDC potable water, uninterrupted
power supply and good communication network.
Soon after acquisition, encore healthcare pvt. Ltd. upgraded the
manufacturing facility to meet Good Manufacturing Standards
and Health and Safety requirements.
Brief Information of the site
GROUP COMPANIESGROUP COMPANIES
 encore healthcare – Paithan (Aurangabad)encore healthcare – Paithan (Aurangabad)
TABLETS, CAPSULES AND LIQUID ORALSTABLETS, CAPSULES AND LIQUID ORALS
CLIENTS : - JOHNSON & JOHNSON,CLIENTS : - JOHNSON & JOHNSON,
NOVARTIS,FULFORD,SOLVAY,GSK & NICHOLASNOVARTIS,FULFORD,SOLVAY,GSK & NICHOLAS
 ZYG Pharma –Pithampur (Indore)ZYG Pharma –Pithampur (Indore)
TOPICAL DERMATOLOGICALTOPICAL DERMATOLOGICAL
CLIENTS-FULFORD,STIEFEL,NICHOLAS,INTASCLIENTS-FULFORD,STIEFEL,NICHOLAS,INTAS
ISO 14001 CERTIFIEDISO 14001 CERTIFIED
 Halcyon Labs -AhmedabadHalcyon Labs -Ahmedabad
APIs, INTERMEDIATESAPIs, INTERMEDIATES
APPROVED SUPPLIER FOR PFIZER (UK)APPROVED SUPPLIER FOR PFIZER (UK)
APPROVED SUPPLIER FOR SCHERRING-PLOUGH (USA)APPROVED SUPPLIER FOR SCHERRING-PLOUGH (USA)
 Encore Natural Polymers -AhmedabadEncore Natural Polymers -Ahmedabad
 GUAR GUM AND DERIVATIVESGUAR GUM AND DERIVATIVES
 ISO 9001 & 14001 CERTIFIEDISO 9001 & 14001 CERTIFIED
encore
Quality Policy
encore healthcare pvt. ltd. is committed to manufacturing quality products to
improve human health and render services to ensure customer satisfaction.
Main objectives are,
• To assure quality, safety and efficacy of the products manufactured.
• To benchmark our systems against the best, globally.
• To impart continuous training and involve all employees in the growth.
• To make quality a way of life regardless of commercial consequences.
Viren Merchant
C.E.O.
Safety Policy
ENVIROMENTAL, HEALTH & SAFETY POLICY
• We encore healthcare pvt. ltd. are in business of developing & manufacturing
ethical pharmaceutical products.
• Our mission is to do so by adhering to regulatory, legal & other requirements.
• Our Vision is to make this earth a beautiful place to live on for mankind by
preventing environmental pollution & safe working place to avoid accidents.
• We commit ourselves to regularly upgrade over environmental & safety protection
system.
• We further commit to achieve our goal by continuous education & training to all
persons working for and on our behalf.
VIREN MERCHANT
C. E. O.
ORGANOGRAM encore
CEO
Sr. V.P. Operation
G.M. R & D G.M. QualityG.M. Plant
Purchase
Manager
Production
AMD F & D
Manager
Pers. & Admin.
Dy. Gen Manager
Stores
Works
Account
Manager
Engineering
Asst. Manager
Executive
Officer
Staff
Officer
Staff
Asst. Manager
Executive
Officer
Staff
Asst. Works
Account
Asst. Manager
Executive
Officer
Staff
Manager
QC
Manager QA
VACANT
Asst. Manager
QC
Executive
Analytical
Executive
MicrobioIogy
Officer
Analytical
Chemists
Officer
Microbiology
Dy. Manager
IPQA
Dy. Manager
Documentation
Asst. Manager
Regulatory
Executives
IPQA Officers
Executives
Officers
Note : Seniority in the organogram is not height indicative
Secretary
IT Executive
Packing material
officer
G.M. Tech
ORGANOGRAM
ENVIRONMENT, HEALTH AND SAFETY
GM (PLANT)
HOD QA
INCIDENT /
ACCIDENT
HOD QC
HEAD
INTERNAL EHS
AUDIT
HOD P & A
HEAD
TRAINNING
AWARENESS
COMPLIANCE
HOD
ENGINEERING
CO-
ORDINATOR &
SECERATY
SAFETY COMMITTEE
HOD
PRODUCTION
HEAD
RISK
ASSESSMENT
encore
Core Area Corridor
Granulations Room
Dosage Forms
•Tablet
—Uncoated
—Coated – Film / Sugar
•Capsule
—Hard Gelatine
•Oral Liquids
—Syrup
—Suspension
encore
CAPACITY
single shift per annum
Dosage Installed Used Available
Tablets 3000 MIO 1800 MIO 1200 MIO
Liquids 750 KL 300 KL 450 KL
Capsules 100 MIO 10 MIO 90 MIO
QUALITY CONTROL
LATEST EQUIPMENTS
WELL EQUIPPED MICRO. LAB
STABILITY TESTING FACILITY
GMP AUDITS
• Audit Conducting Agency Outcome
WHO Approved
Tanzania Approved
Uganda Approved
Ethiopia Approved
Schering Plough, USA Accepted
Janssen cilag Accepted
GSK Accepted
Novartis Accepted
Status of EHS Audit by SP Conducted on 20, 21 Feb 2006
Number of recommendations : 19
Number of Compliance : 19
Number of recommendations pending : Nil
Audit Status
The Effect of CAPA of EHS Audit
Workers safety – Worker Risk Assessment
Evaluations of PPE depending upon MSDS data. Effective
utilizations of PPE during various stages of manufacturing.
Training given to all concern employees on importance of use of
PPF.
Evaluation of employees due exposure to chemical substances by
medical checkup.
Industrial Hygiene
Process and Equipment : Risk Assessment
We have evaluated potential hazards during manufacturing process
and while using equipments. The corrective actions are suggested
and decided preventive measures to avoid risk.
TheEffect of CAPA of EHS Audit
Hazardous Waste Management
WWTP Waste
WWTP effluent is characterized and quantified. We have
designed a procedure for handling and disposition of this
waste.
Organic Waste
We have contract with MEPL for handling and disposition of
organic waste.
Discontinuation of incinerator.
We have discontinued incineration of wastes like paper to
minimize environmental impacts. We have started shredding
of papers before disposition.
SafetyCompliance
Statutory Requirement as per factory act 1948
Complying with Air, Water and Noise control management
Complying with Hazardous Waste Management
Industrial hygiene and health
 Personal protective equipment
 First Aid
 Medical Examination by Certified Surgeon
Safety Procedure
General Safety Rule
Housekeeping Rule
Fire and Safety
encore

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Nachiket

  • 1. encore healthcare pvt.ltd. encore WELCOMES Mr. Shivprasad Nikam GSK 04/06/2013
  • 3. Brief Information of the Site encore is promoted by encore Group of Companies. encore group is having four different manufacturing site engaged in manufacturing of API and intermediate & Pharmaceutical formulations like tablet, capsule, liquid orals & external preparations like creams & ointments. encore group has about 15 years of wide experience in the field of manufacturing and marketing of Bulk drugs and Pharmaceuticals. The registered office of encore group is situated at 405 – 408, Navbharat Estate, ‘B’ Wing, 172 Zakeria Bunder Road, Sewri, West, Mumbai – 400 015.
  • 4. encore healthcare Pvt. Ltd. is pharmaceutical formulations manufacturing facility at MIDC, Paithan, Aurangabad. Site was constructed by May & Baker in the year 1985. May & Baker merged into Rhone-Poulenc and sold it to Nicholas Piramal in the year 2001. encore group acquired the site from Nicholas Piramal in March 2002. Plant was MCA Accreditation until 1994. The site has been supplied by MIDC potable water, uninterrupted power supply and good communication network. Soon after acquisition, encore healthcare pvt. Ltd. upgraded the manufacturing facility to meet Good Manufacturing Standards and Health and Safety requirements. Brief Information of the site
  • 5. GROUP COMPANIESGROUP COMPANIES  encore healthcare – Paithan (Aurangabad)encore healthcare – Paithan (Aurangabad) TABLETS, CAPSULES AND LIQUID ORALSTABLETS, CAPSULES AND LIQUID ORALS CLIENTS : - JOHNSON & JOHNSON,CLIENTS : - JOHNSON & JOHNSON, NOVARTIS,FULFORD,SOLVAY,GSK & NICHOLASNOVARTIS,FULFORD,SOLVAY,GSK & NICHOLAS  ZYG Pharma –Pithampur (Indore)ZYG Pharma –Pithampur (Indore) TOPICAL DERMATOLOGICALTOPICAL DERMATOLOGICAL CLIENTS-FULFORD,STIEFEL,NICHOLAS,INTASCLIENTS-FULFORD,STIEFEL,NICHOLAS,INTAS ISO 14001 CERTIFIEDISO 14001 CERTIFIED  Halcyon Labs -AhmedabadHalcyon Labs -Ahmedabad APIs, INTERMEDIATESAPIs, INTERMEDIATES APPROVED SUPPLIER FOR PFIZER (UK)APPROVED SUPPLIER FOR PFIZER (UK) APPROVED SUPPLIER FOR SCHERRING-PLOUGH (USA)APPROVED SUPPLIER FOR SCHERRING-PLOUGH (USA)  Encore Natural Polymers -AhmedabadEncore Natural Polymers -Ahmedabad  GUAR GUM AND DERIVATIVESGUAR GUM AND DERIVATIVES  ISO 9001 & 14001 CERTIFIEDISO 9001 & 14001 CERTIFIED encore
  • 6. Quality Policy encore healthcare pvt. ltd. is committed to manufacturing quality products to improve human health and render services to ensure customer satisfaction. Main objectives are, • To assure quality, safety and efficacy of the products manufactured. • To benchmark our systems against the best, globally. • To impart continuous training and involve all employees in the growth. • To make quality a way of life regardless of commercial consequences. Viren Merchant C.E.O.
  • 7. Safety Policy ENVIROMENTAL, HEALTH & SAFETY POLICY • We encore healthcare pvt. ltd. are in business of developing & manufacturing ethical pharmaceutical products. • Our mission is to do so by adhering to regulatory, legal & other requirements. • Our Vision is to make this earth a beautiful place to live on for mankind by preventing environmental pollution & safe working place to avoid accidents. • We commit ourselves to regularly upgrade over environmental & safety protection system. • We further commit to achieve our goal by continuous education & training to all persons working for and on our behalf. VIREN MERCHANT C. E. O.
  • 8. ORGANOGRAM encore CEO Sr. V.P. Operation G.M. R & D G.M. QualityG.M. Plant Purchase Manager Production AMD F & D Manager Pers. & Admin. Dy. Gen Manager Stores Works Account Manager Engineering Asst. Manager Executive Officer Staff Officer Staff Asst. Manager Executive Officer Staff Asst. Works Account Asst. Manager Executive Officer Staff Manager QC Manager QA VACANT Asst. Manager QC Executive Analytical Executive MicrobioIogy Officer Analytical Chemists Officer Microbiology Dy. Manager IPQA Dy. Manager Documentation Asst. Manager Regulatory Executives IPQA Officers Executives Officers Note : Seniority in the organogram is not height indicative Secretary IT Executive Packing material officer G.M. Tech
  • 9. ORGANOGRAM ENVIRONMENT, HEALTH AND SAFETY GM (PLANT) HOD QA INCIDENT / ACCIDENT HOD QC HEAD INTERNAL EHS AUDIT HOD P & A HEAD TRAINNING AWARENESS COMPLIANCE HOD ENGINEERING CO- ORDINATOR & SECERATY SAFETY COMMITTEE HOD PRODUCTION HEAD RISK ASSESSMENT encore
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  • 16. Dosage Forms •Tablet —Uncoated —Coated – Film / Sugar •Capsule —Hard Gelatine •Oral Liquids —Syrup —Suspension encore
  • 17. CAPACITY single shift per annum Dosage Installed Used Available Tablets 3000 MIO 1800 MIO 1200 MIO Liquids 750 KL 300 KL 450 KL Capsules 100 MIO 10 MIO 90 MIO
  • 18. QUALITY CONTROL LATEST EQUIPMENTS WELL EQUIPPED MICRO. LAB STABILITY TESTING FACILITY
  • 19. GMP AUDITS • Audit Conducting Agency Outcome WHO Approved Tanzania Approved Uganda Approved Ethiopia Approved Schering Plough, USA Accepted Janssen cilag Accepted GSK Accepted Novartis Accepted
  • 20. Status of EHS Audit by SP Conducted on 20, 21 Feb 2006 Number of recommendations : 19 Number of Compliance : 19 Number of recommendations pending : Nil Audit Status
  • 21. The Effect of CAPA of EHS Audit Workers safety – Worker Risk Assessment Evaluations of PPE depending upon MSDS data. Effective utilizations of PPE during various stages of manufacturing. Training given to all concern employees on importance of use of PPF. Evaluation of employees due exposure to chemical substances by medical checkup. Industrial Hygiene Process and Equipment : Risk Assessment We have evaluated potential hazards during manufacturing process and while using equipments. The corrective actions are suggested and decided preventive measures to avoid risk.
  • 22. TheEffect of CAPA of EHS Audit Hazardous Waste Management WWTP Waste WWTP effluent is characterized and quantified. We have designed a procedure for handling and disposition of this waste. Organic Waste We have contract with MEPL for handling and disposition of organic waste. Discontinuation of incinerator. We have discontinued incineration of wastes like paper to minimize environmental impacts. We have started shredding of papers before disposition.
  • 23. SafetyCompliance Statutory Requirement as per factory act 1948 Complying with Air, Water and Noise control management Complying with Hazardous Waste Management Industrial hygiene and health  Personal protective equipment  First Aid  Medical Examination by Certified Surgeon Safety Procedure General Safety Rule Housekeeping Rule Fire and Safety