PHM 4112: QUALITY ASSURANCE NOTES

PHM 4112: QUALITY ASSURANCE NOTES

1.       Introduction to QA & QC

2.       Pharmaceutical Waste Disposal

3.       Analytical Instrument

4.       Chromatographic Quality Control

5.       Industrial Quality Control

6.       ISO 9001:2008

·                   MS ISO 9001:2008

·                   ISO/IEC 17025:2005(E)

·                  Guide to GMP for Medicinal Products Part 1

·                    Section 2 - GLP Principles

7.       Statistical Method 1

8.       7 QC Tools

9.       Statistical Method 2

10.   Statistical Method 3

11.   Disintegration and Dissolution Tests

12.   QC of Solid Dosage Forms (Physical Characteristics)

13.   Pharmaceutical Storage, Quarantine and Distribution

14.   Sterility Test Methods

15.   Microbial QC of Parental Preparation: sterility Testing and Related Guideline

16.   Pharmaceutical Packaging

Additional Notes

1.       What is a SOP

2.       Audit 

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