Document | Content |
---|---|
Bill of materials | List of all components and their step of use (Supplier, grade) |
Research and Development reports | Historical data of pharmaceutical development of new drug substances and drug products at stage from early development to final application of approval - Quality profiles of manufacturing batches (including stability data) - Specifications and test methods of drug substances, intermediates, drug products, raw materials and components, and their rationale - Change histories of important processes and control parameters |
Risk assessment | Process flow charts - Scale up - Equipment changes - Media and feed preparation |
Process descriptions | Product information - Process step flow diagram - Cell culture steps description (cell line/ inoculum/expansion/production bioreactor - Media and feed preparation - Harvest description - Raw materials/equipment) |
Technology transfer file | Introduction - Manufacturing process description, process parameters - Equipment - Raw materials - Analyses - Safety, environment - Stability (conditions, results) - Packaging (cold chain requirements, etc...) - Cleaning - Shipment characteristics and proper validation if needed - Historical data available |
Technology transfer protocol | Technology transfer description - Scope - Objective - Responsibilities - Process Description - Equipment list (receiving unit) - Raw material list - Reference of Master batch record/number of repetitions and status of batches/acceptance criteria/relevant specifications/description of coaching |
Manufacturing and testing description of the process | Product information - Process step flow diagram - Cell culture steps description (cell line/inoculum/cell expansion/production bioreactor) - Media and feed preparation - Harvest description (holding time/storage conditions) - Raw materials - Equipments |
Routine and non-sampling plans | List of all the samplings that should be taken and kept in addition to the in-process control samples listed in the manufacturing description |
Data recording list | Online and offline data to be monitored and recorded during the process |
Deviation inventory | Description in details of the deviations and reporting of the impact on the product titer and quality |
Technology transfer report | Technology transfer description - Objective - Scope - List of deviations and discussion - Process results and comparison to acceptance criteria -, Conclusions |