3 of 5 Creating the Quality Culture by Sultan Ghani
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Transcript of 3 of 5 Creating the Quality Culture by Sultan Ghani
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Saturday, October the 10, 2015
Creating the Quality Culture
Habib University, Karachi
Sultan Ghani
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What Why How
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What is a Quality Culture?
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Why it is needed in Pharma Industry?
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HOW this culture can be developed and
implemented in pharmaindustry?
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Creating QMS –A step by step approach
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Creating QMS –A step by step approach
QA QC cGMP
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QA
QA covers all matters that individually or collectively influence the Quality
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Management Responsibility
Controlling Document & Traceability
Controlling Purchases and
StorageControlling Non
Conformance
QA
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QA
Self Inspection and Audits CAPA OOS/OOT Change Control
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QCQC-Set of controls that consistently provides assurance of product & process performance
through testing
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QC
Sampling, Specification
& Testing
Test Methods
& Validation
Documentation Compliance
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GMP
A common sense approach for organizing & implementing sets of controls
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GMP
Adequate Premises
Qualified & trained personnel
Suitable equipments
System & process
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ICH Q-10, Q-9The Bible of QMS
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Challenges, Quality System & Conclusion
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Thank You