A PRESENTATION ON ISO IMPLEMENTATION OF PANACEA BIOTEC
A PRESENTATION ON ISO IMPLEMENTATION OF
PANACEA BIOTEC
INTRODUCTION
ISO
ISO CERTIFICATION OF PANACEA
AWARDS AND ACHIVEMENTS
CONCLUSION
INTRODUCTION
Objective: Take idea from grey cell to market in a Proactive manner
VISION: Leading health management company
MISSION: Innovation in support of life
GOAL : To meet every health care need with Panacea biotec brand and Service
PANACEA BIOTEC
•India’s highly progressive research based health management company. •Involved in research , manufacturing and marketing of branded pharmaceuticals formulations, vaccines and natural products. •Ardent research and development efforts have always been a great strength of Panacea biotec.
•Focussed research efforts have led to grant of world wide product patents valid in over 6O countries for panacea biotec.As on 2OO7 , the company has filed 49O patent applications in various parts of the world including India . Of these, 163 have been granted patent.
•Panacea Biotec is the third largest biotechnology company (as per ABLE Survey,2006), as well as among the top 50 pharmaceutical companies (as per ORG IMS July2006) of India. Panacea Biotec has organized its formulation marketing into four SBUs - PRO, Diacar, GROW and Critical Care.
PANACEA BIOTECH
It operates in the following segments:
• VACCINES• DRUG FORMULATION• RESEARCH AND DEVELOPMENT
VACCINES
Panacea biotec has significant presence in prophylacticVaccine market that adhere to international standards of manufacturingAnd clinical development.
Several vaccines have been made by panacea biotec•Oral polio vaccine•Enivac HB( recombinant hepatitis B) vaccine•Ecovac4 a combination vaccine( recombinant hepatitis B and DTP)•Easy four ( Heamophilus influenza type B and DTP)
The company has registered consistent growth in revenue which is contributedBy vaccines supplied to UNICEF as well as growth in supplies to the domesticPrivate vaccine market through the joint venture company , Chiron Panacea Vaccines Pvt. Ltd.
DRUG FORMULATION
Panacea has developed novel drug delivery system to Increase effectiveness,tolerability and compliance.Few technological innovations to be mentioned are:•Nimulid transgel•Safeinject willgo•XeedIn domestic market panacea biotec has an established brand equityIn branded pharmaceutical formulations includingPain managementCardiovascular disordersDiabetes managementOrgan transplant.
Its leading brand are amongst the top 5 positions in their respectivetherpeutic segment.Its brands are amongst the top 200 brands in India with Glizid M rankingat 133 and Nimulid as a brand at 177 according to the secondary stokiest auditby ORG IMS.
Research and Development
The core area of research and development includes:• Vaccine development• Biopharmaceuticals• Drug delivery projects• Drug discoveryIn compliance with international regulatory standards.For carrying out preclinical research, the company has an animal house and Facilities for undertaking in-vitro and in-vivo microbiology, pharmacology,Safety, efficacy and toxicology studies.
R&D BASE AT DIFFERENT PLACES:LAKSH DRUG DISCOVERY R&D CENTREThe company’s state of the art research centre for development of new
chemicalEntities at Mohali, Punjab.SAMPANN DRUG DELIVERY R&D CENTRECentre with scientists to conduct research in the areas of pharmacology,
analyticalChemistry , medicinal chemistry and natural products
VACCINE AND BIOLOGICAL RESEARCH CENTRE
IT is situated at New Delhi , the centre is working on breakthroughVaccines like thermostable pentavalent vaccine .Certain novel vaccines under development at this centre are R anthrax vaccineAnd cell culture based japanese Encephalitis.
BIOPHARMACEUTICAL R&D CENTREIt utilizes molecular biology and genomic toolsCentre has undertaken the development of a peptide based technology forAlopecia management in-licensed from National Institute of Health, USA
GRAND R&D CENTREOn truly international standards Panacea biotec’s 5th R&D centre “GRAND”Is coming up at Navi mumbai.Grand while supporting world wide R&D activities will reflect Panacea biotec’sLeadership in R&D in the field of cancer, airway, GI, CNS and CVS diseases
International Organization
for Standardization
WHAT IS ISO? International-standard-setting body
Founded on 23 February 1947
Headquarters in Geneva, Switzerland
ISO 9001 is for Quality management.
Quality management means what the organization does:
-to satisfy the customer's quality requirements
-comply with regulations
THE ISO 9000 FAMILY
ISO 9001:2008 is the latest, improved version.
It is the only standard in the ISO 9000 family that can be used for certification.
ISO 9000 discusses definitions and terminology and is used to clarify the concepts used by the ISO 9001 and ISO 9004standards.
ISO 9001 contains requirements and is often used for certification purposes
ISO 9004 presents a set ofguidelines and is used to achieve sustained success.
EXPECTED QUALITY
by the Customer
PLANNED QUALITY
by the Company
PRODUCED QUALITY
by the Company
PERCEIVEDQUALITY
by the Customer
Measurement of the Performance of the Company
Measurement of theClient’s satisfaction
ISO 9000:2000 REQUIREMENT
Quality Control Quality Management
Past FutureDetect faults Prevent errorsLook for guilty persons Look for defaults in the processesAccuse Help, Moderate, FacilitatePunish MotivateMicro-management Systematic and systemic management
Quality Control Quality Management
Past FutureDetect faults Prevent errorsLook for guilty persons Look for defaults in the processesAccuse Help, Moderate, FacilitatePunish MotivateMicro-management Systematic and systemic management
Transition towards TQM
ISO CERTIFICATION OF
PANACEA BIOTEC
ISO CERTIFICATION
Panacea Biotec is an ISO 9001:2000 certified company.
Year 19
Vaccine formulation Plant
Pharmaceutical Plant
R&D Centers
• For customers• For internal operations
Increased EfficiencyFactual Approach to Decision Making
DocumentationConsistency
• For Sales & MarketingIncreased Revenue
• For employeesEmployee Morale
• For suppliers
Benefits of ISO 9001:2000
COTND….
Other Benefits
*evaluated, aligned and implemented in a unified way
*minimized miscommunication
*desired result achieved more efficiently *continual improvement
*increased ability to review, challenge and change opinions and decisions
AWARDS & ACHIEVEMENTS
AWARDS & ACHIEVEMENTS Februray15, 2006 – raises US $ 100 Million via FCCB Issue.
May 03,2006- Panacea biotech announces landmark collaboration
with the Nederlands Vaccine Institute
October 17,2006 - pioneers development of dengue vaccine in India.
June 14,2007 – reports 140.9% rise in net profit for financial year ended march 31,2007. Net turnoner by 55.0%.
July 28 ,2007 – launch 7 anti cancer drugs.
CONTD… January 04,2008 ---WHO prequalifies Panacea Biotec for supply of their tetravalent vaccines-EasyFour and Ecovac.
July9,2008 Panacea Biotec receives US Patent for ‘Thank God’ TM.
July11,2008 Easy five vaccine.
August 12, 2008---Panacea Biotec bags Award (USD 34. 2 million) for Pentavalent Vaccine, EasyFive* from UNICEF.
March 22,2010 --Wins financial assistance award for pandyflu (swine flu)
2010 – panacea’s Rs 80 cr hospital ready by 2010.
Received c GMP certification for pharmaceutical formulation facility at Baddi from USFDA , TGA austrailia.
CONCLUSION
CONCLUSION
With the view to gain continuous competitive edge, the organisation has been continuously launching innovative and value added brands.
Total quality management is the cornerstone of the company which resulted in achieving greater milestones in the past couple of years.
Quality is in- built in products & services and integrated in each step.
Company is commited to adhere to the highest quality standards for products its manufactures through a highly qualified and dedicated techno team.
The implementation of Quality standards not only take company to the next level of growth trajectory but also laid the platform for growth with the unwavering commitment of every member or employee of Panacea Biotech
Innovation in Support of Life
PRESENTATED BY:
KHYATI CHOUDHARYBHAWANA PANDEYAPARNA SHARMAANEESHA DUTTA
ANY QUESTIONS