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Quality Management

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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.pk opallab@khi.wol.net.pk
Phone: 92-21-35011046-7, 35020715 Phone: 92-21-35011046-7, 35020715

Table of Content
Contents
Acknowledgement 4 Letter of Transmittal 5 Executive Summary 6 Introduction 7 Mission Statement 7 Vision Statement 8 Primary objective of Opal Laboratories 8 Organizational Chart 8 Pakistan Pharmaceutical Industry 14 Pharmaceutical Country’s Profile 14 Guidance for Pharmaceutical Industry 15 Integrating Good Manufacturing Practices in ISO 9001 16 ISO 9001:2000 at Opal Laboratories 16 Process History 20 Total Quality Department 20 Critical to Quality – Customer’s Perspective 21 Secondary assessment of Product Quality 21 Measurement of CTQ’s 23 Quality Management Framework 25 Issue encountered by Opal Laboratories 26 Defining the issue with the Product 26 Analysis of the Issue 27 Resolution of the Issue 28 Accelerated Studies 29 Redesign Process 29 Recommendations 31 Conclusion 32

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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

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