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SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
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Course Outline
Continuous Assessment Marks Semester_2_2022_2023
Dr. Rushdi
Reference: Q10 Pharmaceutical Quality System
Introduction to PQM
Guidelines Related to PQM
Computerised System
Personnel and Premise According to GMP
Quality & Validation 1 (Utilities)
Quality & Validation 2 (Equipment)
Handling Deviations
-Corrective Action and Preventive Action
Pharmaceutical Quality Management From Islamic View
Dr. Helal
QC and Good LaboratorPractice
Validation and Verification in QC
OOS
OOS template
Dr. Siti Hadijah
GDP
Dr. Solah
Guidelines: PICS GMP Guide with Annexes
Lecture slides: Production According to GMP
Lecture slides:Quality and Validation 3 (Process Validation)
Lecture slides: Quality and Validation 4 (Cleaning Validation)
Lecture slides:Quality Risk Management
Form: Risk Assessment Evaluation & Report Form
Case Study 1
Grouping for case studies
Case Study 1
Assessment Rubrics
Submission of Infographic
Submission of Video
Case Study 2 & 3
Case Study 2 & 3
Report Assessment Rubric
Video Presentation Assessment Rubric
Submission of Case Study 2 Report
Submission of Case Study 2 Video
Submission of Case Study 3 Report
Submission of Case Study 3 Video
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Session 2022/2023 Semester 2
PHARMACY
PPPT 3282 SEM2
Summary
SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
Instructor:
MOHD. RUSHDI BIN HJ. ABU BAKAR 4033
Instructor:
A.B.M. HELAL UDDIN 4478
Instructor:
SITI HADIJAH BINTI SHAMSUDIN 4916
Instructor:
MUHAMMAD SALAHUDDIN BIN HARIS @ HARITH 6657
Instructor:
ASSOC. PROF. DR. NG SHIOW FERN kop_ext_exam2
Skill Level
:
Beginner