The document outlines the principles and practices of in-process quality control (IPQC) in the pharmaceutical industry, emphasizing the importance of ensuring product quality, safety, and compliance with regulatory standards. It details various types of pharmaceutical dosage forms, key quality control tests, challenges faced in IPQC, and the role of technological advancements and automation in improving quality control processes. The conclusion reinforces the need for continuous improvement and invites discussion on the topic.

1. In-Process Quality Control of
Pharmaceutical Dosage Forms
Ensuring Consistent Quality and
Safety
Your Name
Date

2. Introduction to Quality Control in
Pharmaceuticals
• Definition of Quality Control (QC)
• Importance of QC in the pharmaceutical
industry

3. Objectives of In-Process Quality
Control (IPQC)
• Ensuring product quality and safety
• Compliance with regulatory standards
• Reducing waste and improving efficiency

4. Regulatory Framework and
Guidelines
• Overview of regulatory bodies (FDA, EMA,
WHO)
• Key guidelines and standards (GMP, ICH Q10)

5. Pharmaceutical Dosage Forms
• Types of dosage forms (solid, liquid, semi-
solid, and others)
• Examples of each type

6. Key In-Process Quality Control
Tests
• Uniformity of dosage units
• Weight variation
• Hardness and friability of tablets

7. Dissolution Testing
• Importance of dissolution testing
• Methods and apparatus used

8. Disintegration Testing
• Purpose of disintegration testing
• Standard methods

9. Content Uniformity
• Ensuring uniform distribution of active
ingredients
• Testing methods

10. Microbial Limits Testing
• Importance of microbial control
• Methods for microbial testing

11. In-Process Control for Sterile
Dosage Forms
• Sterility testing
• Environmental monitoring

12. Packaging and Labeling Controls
• Importance of correct packaging and labeling
• Common checks and controls

13. Data Integrity and Documentation
• Importance of accurate documentation
• Best practices for maintaining data integrity

14. Challenges in In-Process Quality
Control
• Common challenges faced
• Solutions and best practices

15. Case Study: Quality Control in
Tablet Manufacturing
• Overview of a typical QC process in tablet
production
• Key checks and controls

16. Technological Advances in IPQC
• New technologies and methods
• Impact on quality control processes

17. Role of Automation in Quality
Control
• Advantages of automation
• Examples of automated QC processes

18. Future Trends in Pharmaceutical
Quality Control
• Emerging trends and innovations
• Predicted impacts on the industry

19. Conclusion
• Summary of key points
• Importance of continuous improvement in QC

20. Questions and Discussion
• Open floor for questions
• Encouraging discussion and feedback