EHS

1. encore healthcare pvt.ltd.
encore
WELCOMES
Mr. Shivprasad Nikam
GSK
04/06/2013

2. encore group
Promoters:
Sudhir Merchant
&
Viren Merchant
encore

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

11. Core Area Corridor

13. Granulations Room

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

24. encore