Process Development for Therapeutics - Finished Dose Forms

Aims and Objectives

This subject aims:

• To provide an understanding the necessity for quality assurance, good manufacturing practice, good laboratory practice and quality control in the pharmaceutical industry.
• To develop an understanding of full scale manufacturing technologies.
• To develop an understanding of process optimization and validation relating to process technologies for finished dose forms

On completion of this subject students will be able to:

• Provide a basic understanding of quality management for a pharmaceutical finished dose form
• Describe the process conditions that impact quality for different dose forms such as topicals and solid dose forms
• State process control and validation strategies for these dose forms

Content

• Quality Assurance of finished dose forms
• Requirements for Good Manufacturing Practice and Good Laboratory Practice
• Starting materials, product supply
• Solid dose forms
  • Steps in manufacture
  • Granulation technology
  • Blending technology
  • Particle size
  • Excipients
  • Blend Uniformity
  • Coating technology
  • Compression
  • Encapsulation
• Topical dose forms
  • Formulation of creams and ointments
  • Bulk manufacture
  • Homogenisation
  • Excipients
  • Packaging
  • Microbiological Control
• Various case studies of GMPs and finished dose forms in the pharmaceutical industry

Planned Modules

1. 1. Introduction to Solid Dose Formulation
2. Granulation Technology
3. Bulk Blending and Milling
4. Compression, Encapsulation and Coating
5. Introduction to Topical Preparation Formulation
6. Manufacture of Creams and Ointments