Quality Assurance

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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, and of acceptable quality. A comprehensive quality assurance program includes both technical and managerial activities, spanning the entire supply process from pharmaceutical selection to patient use. A quality assurance program should include training and supervision of staff members at all levels of the production and supply process and a suitable information system.

Signature of Student:Signature of Instructor

Date: 20th September 2012 Date: 20th September 2012

Contents

ACKNOWLEDGEMENT3
Abstract:4
Introduction6
Pharmaceutical quality assurance framework7
Qualification and validation8
Product recalls9
Self-inspection and quality audits9
Personnel11
Training12
Premises13
Documentation14
Packaging materials16
Practical approaches to quality assurance17
Conclusion18
References19

Introduction
“Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.

1.2 The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
(a) pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP)1 and good clinical practice (GCP);

(b) production and control operations are clearly specified in a written form and GMP requirements are adopted;

(c) managerial responsibilities are clearly specified in job descriptions;

(d) arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;

(e) all necessary controls on starting...
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