IMPD/ CTD section Requirements applicable to all ATMPs
3.2.S. Drug Substance 3.2.S. Drug Substance
3.2.S.1. General information
· Nomenclature of the product. · Information on the structural component and summary of the physical and biological characteristics of the substance. · General physicochemical properties of the active substance.
3.2.S.2. Manufacture
· List of manufacturers of the active substance. · Summary of the manufacturing process (complete flowchart and reagents used should be included). · Controls of materials (e.g., raw materials, starting materials, reagents) · Controls of critical steps and intermediates of the active substance. · Description of any development work done to optimise the production operations.
3.2.S.3. Characterization
· Elucidation of structure and other characteristics. · Impurities (process-related impurities and cellular impurities).
3.2.S.4. Control of the drug substance
· Specifications (for the active substance release). · Description of the analytical methods used for testing the active substance. · Suitability, qualification, or validation data of the analytical methods used (depend on the status of the product development). · Batch analysis (tables of all the manufactured data of the active substance). · Justification of specifications.
3.2.S.5. Reference Standards or Materials · Characterization of the batch substance to establish a reference standard (only in case of international standards available).
3.2.S.6. Container Closure System · Information on the immediate packing material.
3.2.S.7. Stability · Data of storage conditions (in case it is not immediately processed).
3.2.P. Drug Product 3.2.P. Drug Product
3.2.P.1. Description and composition · Qualitative and quantitative composition of the finished medicinal product.
3.2.P.2. Pharmaceutical development · Short description of the formulation development and justification of using any new pharmaceutical form or excipient.
3.2.P.3. Manufacture
· List of manufacturers of the drug product. · Description of the manufacturing process and controls. · Control of all material used in the manufacture of the substance. · Control of critical steps and intermediates. · Process validation and/or evaluation. · Manufacturing process development.
3.2.P.4. Control of excipients · References to the pharmacopoeia for the excipient’s specifications.
3.2.P.5. Control of the medicinal product
· Drug product specifications (quality attribute) for product release. · Analytical procedures and validation of these analytical methods. · Batch analysis (with data from all the manufactured drug products). · Additional impurities observed in the medicinal product. · Justification of the specifications (for product release).
3.2.P.6. Reference Standards or Materials · Parameters for characterisation of reference standards (where applicable).
3.2.P.7. Container Closure System · Information on the immediate packaging material.
3.2.P.8. Stability · Stability studies of the medicinal product.