Quality Management

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Institute Of Business Management
Total Quality Management
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Term Report
Company: Opal Laboratories (pvt) Limited

Submitted to: Mr. Moinuddin Khan
Submitted by: Mohammad Tobeh(11931)
Muffaddal Moosajee(7743)
Muhammad Tariq Qazi(7193)
Date of Submission:20th December, 2012

Contact Information

Mr. Tariq Ikram Mr. Arif Ikram
CEO, Opal Laboratories COO, Opal Laboratories
Head Office & Plant: LC-41, L.I.T.E Head Office & Plant: LC-41, L.I.T.E. Landhi, Karachi, Pakistan Landhi, Karachi, Pakistan
opallab@khi.wol.net.pkopallab@khi.wol.net.pk
Phone: 92-21-35011046-7, 35020715 Phone: 92-21-35011046-7, 35020715

Table of Content
Contents
Acknowledgement4
Letter of Transmittal5
Executive Summary6
Introduction7
Mission Statement7
Vision Statement8
Primary objective of Opal Laboratories8
Organizational Chart8
Pakistan Pharmaceutical Industry14
Pharmaceutical Country’s Profile14
Guidance for Pharmaceutical Industry15
Integrating Good Manufacturing Practices in ISO 900116
ISO 9001:2000 at Opal Laboratories16
Process History20
Total Quality Department20
Critical to Quality – Customer’s Perspective21
Secondary assessment of Product Quality21
Measurement of CTQ’s23
Quality Management Framework25
Issue encountered by Opal Laboratories26
Defining the issue with the Product26
Analysis of the Issue27
Resolution of the Issue28
Accelerated Studies29
Redesign Process29
Recommendations31
Conclusion32

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Acknowledgement

Dear Reader,
All praises and thanks go to Almighty Allah, the Lord and Creator of the universe through whose power and glory things are accomplished. He is the most merciful, who has bestowed on us the utmost potential, opportunity and ability to compile this report. We, the group members who have compiled this report would like to extend our gratitude to our respected teacher Mr. Moinuddin Khan, who has guided and mentored us throughout this report. This report has provided us an opportunity to learn how to implement the material we have covered in our course. This experience has not only added value to our knowledge but given us the experience of how to work together as a team. It was his dedication and support in guiding us and presenting the proper outline on how to present this report as well as learn practical life experience in a well-defined way. With his experience, expertise and knowledge, we were lead in an organized manner throughout the course and in the preparation of this report We would like to thank all the people who we visited especially Mr. Tariq Ikram and Mr. Arif Ikram who provided us with extensive information. It is due to them and their staff that we were able to gather all the necessary and relevant information and compile this report.

Letter of Transmittal

20th December, 2012

Mr. Moinuddin Khan
Institute of Business Management
Korangi Creek
Karachi

Dear Sir,
Following is the Term Report that we have selected as our final project. This report is regarding Opal laboratories (pvt) ltd. This is a pharmaceutical manufacturing company in Pakistan. In this report we have discussed the Role of Quality Management in Pharmaceutical Development and implementation which is related to ISO 9001. Furthermore we have included information regarding ISO 13485, a standard for medical devices. We have tried our level best to maintain consistency of the report. If you have any queries please feel free to contact us.

Sincerely,
Mohammad Tobeh
Muffaddal Moosajee
Muhammad Tariq Qazi

Executive Summary

This report discusses in detail the concept of ISO 9001:2000 and how it is used in an organization. This topic is an important element of our course “Total Quality Management” This report provides extensive information...
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