Solid Dose Manufacture Principles and Practices

Aims: 
To provide an introduction to the GMP requirements for the formulation, scale up and optimization of Finished Dose Forms, and to develop a practical understanding of Process Mapping, Risk Analysis and Critical Control points, Validation requirements and Quality Plans as it applies to solid dose formulations.

Outline Syllabus: 

• Review of Granulation technology
• Technology equipment options
• Statistical process Control over compression
• Review of Blending technology
• Blend Uniformity and Validation
• Review of Coating technology
• Coating Control and Validation
• Powder Transfer Technology and Containment Systems
• Manufacturing Productivity
• Review of Encapsulation technology
• Encapsulation Control and Validation
• Review of Packagigg  technology
• Packaging Control and Validation

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Understand solid dose manufacture and the various technologies available, and the impact of the process steps on ingredients/materials and finished production.
• Understand the theory behind the processes for the manufacturing of finished dosage forms, including different equipment options of the following technologies:
• Granulation
• Blending & Milling
• Powder Transfer and Containment
• Compression
• Coating
• Identify the key formulation components of granulations and explain the purpose of the inclusion of those materials in the formulation.
• Describe the Process Conditions that Impact the Quality of Powder Blends
• Understand the Major Quality Control Techniques in Evaluating & Controlling the Quality of Powder Blends, Granulations and tablets
• Describe the Common Levels of Containment in the Pharmaceutical Industry
• Describe the common QC tests conducted to monitor in process bulk and tablet quality

(2) Discipline skills

• Prepare Process Maps to define the manufacturing process.
• Apply risk assessment to process validation and the development of QA plans.
• Use Process Maps and a Risk Assessment of processes to identify critical manufacturing steps.
• Identify the problems that can occur during the process steps of solid dose manufacturing and implement strategies to prevent them.