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FAR424 FARMASI INDUSTRI (INDUSTRIAL PHARMACY)
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Announcements
Dr Peh
Validation - Qualification and Process validation
Lecture 1 - Qualification & Process Validation
Asean guideline on submission of manufacturing process validation data for drug registration
Asean guideline on process validation - Q&A
Overview on Asean guideline on PV requirements
PIC/S Guide to GMP for Medicinal Products Part I
Part II
Annexes
Lecture 2 - Cleaning Validation
Article 1
Article 2
Article 3
Article 4
Lecture 3 - Good Distribution Practice - lecture notes
GDP Part 1
GDP Part 2
GDP Part 3
GDP Part 4
GDP Part 5
Guideline on GDP 3rd Edition (2018)
Lecture 4 - Water for Pharmaceutical Use
USP Guideline
WHO (draft) guideline
EMA guideline
Training modules on GMP - Water for Pharmaceutical use Part 1
Part 2
Part 3
Lecture 5 - HVAC
GMP HVAC - Part 1(a)
GMP HVAC - Part 1(b)
GMP HVAC - Part 2
GMP HVAC - Part 3
Supplementary Guideline on GMP for HVAC systems for non-sterile pharmaceutical dosage forms
Good Manufacturing Practice - Introduction
ASEAN Guideline on GMP for TMHS
Cosmetic GMP
Important Information
Synopsis and Learning Outcomes of the Course
Information on Assessments
Lecture Timetable
Practical Timetable
Timetable for Viva (17/01/23)
Dr. Nina
Regulatory Requirements in Industrial Pharmacy (Part 1)
Regulatory Requirements in Industrial Pharmacy (Part 2)
Regulatory Requirements in Industrial Pharmacy (Part 3)
Formative Assessment 1
Formative Assessment 2
Formative Assessment 3
Introduction to Pharmacovigilance
Pharmacovigilance in Industrial Pharmacy
Risk Management
CAPA Management System
Cross Contamination and Mix-Up
Assignment Topic
Assignment
Submission of GMP assignment
Practical Manual
Practical Manual (Uniformity and Composition)
Attachment to Part A
Practical Manual (Microbiological QC)
Dr Suriani's Lecture
Lecture 1: Microbial Quality Control of Pharmaceutical Preparations
Lecture 2 & 3
Lecture 4: Water Quality
Lecture 5: Water in the Pharmaceutical Industrty
Lecture 6: Water purification systems
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APPLIED SCIENCES
SCHOOL OF PHARMACEUTICAL SCIENCES
Summary
Course info
FAR424 FARMASI INDUSTRI (INDUSTRIAL PHARMACY)
Lecturer:
DR. SURIANI BINTI MOHAMAD
Lecturer:
PROF. TS. CHM. DR. AHMAD ZUHAIRI BIN ABDULLAH
Lecturer:
PROFESOR DR. PEH KOK KHIANG
Lecturer:
PROFESOR MADYA DR. NURZALINA BINTI ABDUL KARIM KHAN
Skill Level
:
Beginner