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SEM2 PPPT 3282 PHARMACEUTICAL QUALITY MANAGEMENT
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Course data
General
Announcements
Course Outline
Dr. Rushdi
Course Briefing
Introduction to PQM
Guidelines Related to PQM
Personnel & Premise
Computerised System
Quality & Validation 1: Equipment
Quality & Validation 2: Utilities
Handling Deviations
CAPA
Supplementary Reading: How to Manage CAPA?
PQM from Islamic View
Dr. Helal
QC and Good laboratory Practice
Validation and verification in QC
OOS - Out of Specification
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)
Additional Reading: Cleaning Validation Maximum Allowable Concentration
Lecture slides:Quality Risk Management
Guidelines: ICH Q9-R1 Quality Risk Management
Form: Risk Assessment Evaluation & Report Form
Case Studies
Case Studies Assignment
Rubrics for Written Report
Rubrics for Video Presentation
Recommended Outline for Written Report
What is “(b)(4)” ?
Submission of Case Study 1 (Written Report)
Submission of Case Study 1 (5-min video)
Submission of Case Study 2 (Written Report)
Submission of Case Study 2 (5-min video)
Submission of Case Study 3 (Written Report)
Submission of Case Study 3 (5-min Video)
Dr. Siti Hadijah
OUTSOURCE ACTIVITIES & CONTRACT MFG
GDocP
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Session 2023/2024 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. Haliza Katas
Skill Level
:
Beginner