Summary of FAR426 FARMASI INDUSTRI (INDUSTRIAL PHARMACY)

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FAR426 FARMASI INDUSTRI (INDUSTRIAL PHARMACY)

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

General

Announcements

Details of assessments and datelines

FAR 426 Assignment

Lecture 1 - Good Distribution Practice (GDP) - Part 1

GDP - Part 2

GDP - Part 3

GDP - Part 4

GDP - Part 5

Good Distribution Practice Guideline 3rd Edition, 2018

Good Distribution Practice 2nd Edition, 2013

Lecture 2 - Validation - Process and Cleaning Validations

Validation

PIC/s GMP 2023

PIC/s Annexes 2023

Process and Cleaning Validation

Asean guideline on Manufacturing Process Validation

Annex B Table of Content of Process Validation Documentation

Overview on ASEAN Guideline on Process Validation Requirements

Cleaning Validation

Articles - Cleaning Validation

Lecture 3 - Water System for Pharmaceutical Use

WHO GMP Water for Pharmaceutical Use - Part I

Part 2

Part 3

EMA Guideline on Water for Pharmaceutical Use

Lecture 4 - Heating, Ventilation and Air-conditioning (HVAC) systems

CMP HAVC - Part 1(a)

GMP HVAC - Part 1(2)

GMP HVAC - Part 2

GMP HVAC - Part 3

WHO Supplementary guideline Working Document

WHO Annex 5

Presentation - Fundamental of cGMP for Pharmaceutical HVAC Systems

Lecture 5 - Good Manufacturing Practice

PIC/s GMP guide 2023 - Introduction

PIC/s GMP guide - Part 1

PIC/s GMP guide - Part II

Annexes

ASEAN Guidelines on GMP for TM and HS

Chapter 1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

Chapter 6

Chapter 7

Chapter 8

Chapter 9

Chapter 10

Guideline for Control of Cosmetic Products in Malaysia

Guideline for Cosmetic GMP

Guideline for Veterinary

Guideline on GMP for Veterinary Premixes

Lecture 6 - Process Control

Sample Batch Manufacturing Record

Dr. Nina's Lectures

Regulatory Requirements in Industrial Pharmacy Part 1

Regulatory Requirements in Industrial Pharmacy Part 2

Regulatory Requirements in Industrial Pharmacy Part 3

Pharmacovigilance and Pharmaceutical Industry

Management of Product Development

Operations Management

Quality Management Part 1

Quality Management Part 2

Quality Management Part 3

Quality Management Part 4

Viva Voce Evaluation

Viva voce evaluation

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