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GMP

Nur Aqilah

Created on January 2, 2024

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Transcript

DHV40133 Good

manufacturing

Practice

by Nur Aqilah Zulkifli

Course Learning Outcome

CLO2

Find the requirement of Good Manufacturing Practices (GMP) and standard operating procedure (SOP) in different type of system based on GMP guideline. (PLO3, C4)

CLO 1

Describe the principles of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Halalan Toyyiban (PLO1, C2)

CLO 3

Prepare various required documentations as per GMP requirement (PLO6, A3)

Index

CONTROL PRODUCTION AND ANALYSIS

8.

INTRODUCTION

1.

DISTRIBUTION, COMPLAINT AND PRODUCT RECALLS

9.

QUALITY MANAGEMENT

2.

PERSONNEL

3.

10.

SELF INSPECTION

PREMISES AND EQUIPMENT

4.

HALALAN TOYIBAN

11.

GOOD STORAGE PRACTICE (GSP) FOR HERBALS

12.

DOCUMENTATION

5.

PRODUCTION

6.

QUALITY CONTROL

7.

INTRODUCTION

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1.1 Introduction Good Manufacturing Practice (GMP) for Pharmaceutical, Cosmetics and Traditional Medicines 1.2 Requirement of GMP 1.3 Importance of standardization products in global competition 1.4 Certification & branding

+ info

QUALITY MANAGEMENT

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2.1 Quality Assurance 2.2 Quality Control 2.3 GMP 2.4 Product Quality Review

+ info

PERSONNEL

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3.1 Organization, qualification and responsibilities 3.2 Records 3.3 Training 3.4 Personnel hygiene

+ info

PREMISES AND EQUIPMENT

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4.1 Premises (General) 4.2 Location and design 4.3 Production and area 4.4 Storage area 4.5 Quality Control area 4.6 Cleaning and sanitation of premises 4.7 Equipment 4.8 Cleaning and sanitation equipment

+ info

DOCUMENTATION

5.1 General principle 5.2 Quality documentation 5.3 Production documentation 5.4 Standard Operation Procedure (SOP) and record

+ info

PRODUCTION

6.1 General principle 6.2 Verification and validation 6.3 Prevention of cross contamination 6.4 Starting material 6.5 Processing operation: Intermediate and bulk products 6.6 Packaging material 6.7 Packaging operations 6.8 Finished product 6.9 Rejected, recovered and returned material

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+ info

QUALITY CONTROL

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7.1 Principle 7.2 Sampling 7.3 Testing Stability study

+ info

CONTROL PRODUCTION AND ANALYSIS

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8.1 Contract production 8.2 Contract testing 8.3 The contract giver 8.4 The contract acceptor 8.5 The contract

+ info

DISTRIBUTION, COMPLAINT AND PRODUCT RECALLS

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9.1 Product distribution 9.2 Product complaint 9.3 Product recall protocol 9.4 Good Distribution Practice (GDP)

+ info

SELF INSPECTION

10

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10.1 Principle

+ info

HALALAN TOYIBAN

11

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11.1 Malaysian Standard MS 1500:2004 11.2 Halal Food Production 11.3 Preparation, Handling and Storage

+ info

GOOD STORAGE PRACTICE (GSP) FOR HERBALS

12

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12.1 Principles 12.2 FIFO 12.3 Separation/designation of areas 12.4 Ventilation 12.5 Humidity 12.6 Light 12.7 Temperature 12.8 Cleanliness 12.9 Maintenance

+ info

Assessment weightage

CLO 1 50%

30% Theory test, 20% Final theory

20% Final theory 15% Assigment

CLO 2 35%

5% Presentation 10% Assignment

CLO3 15%

An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.
An awesome presentation:
  • It is clear and structured.
  • Presents information in an organized way.
  • Engages the whole class.
  • Adapts fonts and color to the theme.
  • Includes images and entertains.
  • Represents data and information visually.
  • Uses timelines.
  • Is animated and interactive.
  • Excites the brain through multimedia elements.
  • Does NOT exceed with bullet points 🙃​.