Quality Assurance
A REPORT
ON
QUALITY ASSURANCE IN PHARMACEUTICALS
BY
Shikher Gupta
2009A5PS626P
AT
HETERO DRUGS LTD.
A Practice –II station of
BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE, PILANI
A REPORT
ON
QUALITY ASSURANCE IN PHARMACEUTICALS
BY
Shikher Gupta
2009A5PS626P
B.Pharmacy(Hons.)
Prepared in partial fulfillment of the
Practice School II Course
AT
HETERO DRUGS LTD.
A Practice School – II station of
BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE, PILANI
SEPTEMBER, 2012
ACKNOWLEDGEMENT
I have taken efforts in this project. However, it would not have been possible without the kind support and help of many individuals and organizations. I would like to extend my sincere thanks to all of them.
I am highly indebted to my mentor Mr.Chandra Reddy, Manager (QA) and PS faculty Prof. J.T Rao for their guidance and constant supervision as well as for providing necessary information regarding the project and also for their support in completing the project.
I would like to express my gratitude towards Mr. Vamsikrishna Bandi, Managing Director Hetero Drugs Ltd. for his kind co-operation and encouragement which helped me in completion of this project.
I would like to express my special gratitude and thanks to industry persons for giving me such attention and time.
Birla Institute of Technology and Science
Pilani (Rajasthan)
Station: Hetero Drugs Pvt. ltd
Duration: 4th July - 14th December 2012 Date of Start – 6th July 2012
Date of Submission: 6th October 2012
Title of the Project: Quality assurance in Pharmaceuticals
Name: Shikher Gupta ID No: 2009A5PS626P
Name and designation of Mentor: Mr Chandra Reddy, Manager QA
Name of PS faculty: Prof. J.T Rao
Abstract : The purpose of quality assurance in pharmaceutical industry is to help ensure that each medicine reaching a patient is safe, effective,
ON
QUALITY ASSURANCE IN PHARMACEUTICALS
BY
Shikher Gupta
2009A5PS626P
AT
HETERO DRUGS LTD.
A Practice –II station of
BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE, PILANI
A REPORT
ON
QUALITY ASSURANCE IN PHARMACEUTICALS
BY
Shikher Gupta
2009A5PS626P
B.Pharmacy(Hons.)
Prepared in partial fulfillment of the
Practice School II Course
AT
HETERO DRUGS LTD.
A Practice School – II station of
BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE, PILANI
SEPTEMBER, 2012
ACKNOWLEDGEMENT
I have taken efforts in this project. However, it would not have been possible without the kind support and help of many individuals and organizations. I would like to extend my sincere thanks to all of them.
I am highly indebted to my mentor Mr.Chandra Reddy, Manager (QA) and PS faculty Prof. J.T Rao for their guidance and constant supervision as well as for providing necessary information regarding the project and also for their support in completing the project.
I would like to express my gratitude towards Mr. Vamsikrishna Bandi, Managing Director Hetero Drugs Ltd. for his kind co-operation and encouragement which helped me in completion of this project.
I would like to express my special gratitude and thanks to industry persons for giving me such attention and time.
Birla Institute of Technology and Science
Pilani (Rajasthan)
Station: Hetero Drugs Pvt. ltd
Duration: 4th July - 14th December 2012 Date of Start – 6th July 2012
Date of Submission: 6th October 2012
Title of the Project: Quality assurance in Pharmaceuticals
Name: Shikher Gupta ID No: 2009A5PS626P
Name and designation of Mentor: Mr Chandra Reddy, Manager QA
Name of PS faculty: Prof. J.T Rao
Abstract : The purpose of quality assurance in pharmaceutical industry is to help ensure that each medicine reaching a patient is safe, effective,
References: * Good Manufacturing Practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823), Annex 1. * Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide. Rockville, Md.: United States Pharmacopeial Convention. http://www.usp.org/pdf/EN/dqi/ensuringQualityOperationalGuide.pdf * Access to Essential Medicines: Rajasthan, India, 2001.Prepared for the Strategies for Enhancing Access to Medicines Program. Arlington, Va.: Management Sciences for Health. * Center for Pharmaceutical Management: Technical Frameworks, Approaches, and Results. Arlington, Va.: CPM. FDA (U.S. Food and Drug Administration). 2010. Office of International Programs website. http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofInternationalPrograms/default.htm * http://whqlibdoc.who.int/hq/1991/ WHO_DAP_91.1.pdfDocument3 * http://apps.who.int/prequal/WHOPIR/archive/WHOPIR_Hetero12-13June06.pdf * Pharmaceuticals: Quality Assurance in the Distribution Chain. Washington, D.C.: World Bank. http://apps.who.int/medicinedocs/documents/s16759e/s16759e.pdf * http://en.wikipedia/qualityassurance