Saturday, October the 10, 2015

Creating the Quality Culture

Habib University, Karachi

Sultan Ghani

What Why How

What is a Quality Culture?

Why it is needed in Pharma Industry?

HOW this culture can be developed and

implemented in pharmaindustry?

Creating QMS –A step by step approach

Creating QMS –A step by step approach

QA QC cGMP

QA

QA covers all matters that individually or collectively influence the Quality

Management Responsibility

Controlling Document & Traceability

Controlling Purchases and

StorageControlling Non

Conformance

QA

QA

Self Inspection and Audits CAPA OOS/OOT Change Control

QCQC-Set of controls that consistently provides assurance of product & process performance

through testing

QC

Sampling, Specification

& Testing

Test Methods

& Validation

Documentation Compliance

GMP

A common sense approach for organizing & implementing sets of controls

GMP

Adequate Premises

Qualified & trained personnel

Suitable equipments

System & process

ICH Q-10, Q-9The Bible of QMS

Challenges, Quality System & Conclusion

Thank You