GMP

by Nur Aqilah Zulkifli

DHV40133 Good

manufacturing

Practice

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

CLO 3

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

CLO2

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

CLO 1

Course Learning Outcome

Index

1.

INTRODUCTION

2.

QUALITY MANAGEMENT

3.

PERSONNEL

4.

PREMISES AND EQUIPMENT

5.

DOCUMENTATION

6.

PRODUCTION

7.

QUALITY CONTROL

8.

CONTROL PRODUCTION AND ANALYSIS

9.

DISTRIBUTION, COMPLAINT AND PRODUCT RECALLS

10.

SELF INSPECTION

11.

HALALAN TOYIBAN

12.

GOOD STORAGE PRACTICE (GSP) FOR HERBALS

+ info

INTRODUCTION

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

Animate your content and take it to the next level

+ info

QUALITY MANAGEMENT

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

Animate your content and take it to the next level

+ info

PERSONNEL

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

Animate your content and take it to the next level

+ info

PREMISES AND EQUIPMENT

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

Animate your content and take it t the next level

+ 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

Animate your content and take it to the next level

+ info

QUALITY CONTROL

7.1 Principle 7.2 Sampling 7.3 Testing Stability study

Animate your content and take it to the net level

+ info

CONTROL PRODUCTION AND ANALYSIS

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

Animate your content and take it to the next level

+ info

DISTRIBUTION, COMPLAINT AND PRODUCT RECALLS

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

Animate your content and take it to the next level

+ info

SELF INSPECTION

10.1 Principle

Animate your content and take it to the next level

10

+ info

HALALAN TOYIBAN

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

Animate your content and take it to the next level

11

+ info

GOOD STORAGE PRACTICE (GSP) FOR HERBALS

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

Animate your content and take it to the ext level

12

Assessment weightage

CLO 1 50%

30% Theory test, 20% Final theory

CLO 2 35%

20% Final theory 15% Assigment

CLO3 15%

5% Presentation 10% Assignment

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 🙃​.