Understanding Granularity
Granularity refers to the level of detail and depth in the technology transfer process.
It ensures that all components of the product are thoroughly understood and effectively transferred.
Transfer of Active Pharmaceutical Ingredients (APIs)
Synthesis Process: Detailed procedures for chemical synthesis or biological production.
Purity Requirements: Specifications for impurities and degradation products.
Stability Data: Information on API stability under various conditions.
Excipients Transfer
Compatibility Studies: Assessing interactions between excipients and APIs.
Specifications: Defining physical and chemical properties.
Supplier Qualification: Ensuring consistent quality from excipient suppliers.
Finished Products
Formulation Processes: Detailed instructions on blending, granulation, compression, etc.
Process Parameters: Critical parameters that affect product quality.
Stability Considerations: Shelf-life and storage conditions.
Packaging Materials
Material Specifications: Detailed descriptions of packaging components.
Compatibility Testing: Ensuring packaging does not affect product quality.
Supplier Assessment: Evaluating and qualifying packaging material suppliers.