Liquid and Cream 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 liquids and creams formulations.

Outline Syllabus: 

• Bulk formulation of creams and ointments
• Formulation Considerations
• Preservative Systems and PET Testing
• Technology for topical products
• Packaging and Microbiological Control of Topical Products
• Facility Standards
• Filling topical products control
• Statistical process  control over packaging
• Technology transfer
• Production scale-up and optimisation

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

(1) Knowledge and Understanding

• Understand liquid and cream manufacture and the various technologies available,
• Understand the role of interactions of ingredients/materials
• Understand the impact of the process steps on ingredients/materials and finished production.
• Identify the key formulation components of granulations and explain the purpose of the inclusion of those materials in the formulation;
• State the various methods of manufacturing liquid and cream products and describe the type of equipment used in manufacture.
• Describe the Process Conditions that Impact the Quality of Liquids and Creams
• Understand the Major Quality Control Techniques in Evaluating & Controlling the Quality of Liquids and Creams
• Understand the critical activities and success factors required for an effective and efficient technology transfer
• Knowledge of the critical factors of scale-up and their impact on manufacturability.

(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 liquids and creams manufacturing and implement strategies to prevent them.