CDSCO - Guidance for Industry - Central Drugs Standard Control ...

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Guidance for Industry Central Drugs Standard Control Organization Page 156   Information on the cell banking system, quality control activities, and cell line stability during production and storage (including procedures used to generate the Master and Working Cell Bank(s)) should be provided. This information could also include, for example: details of testing performed on all cell banks, and a flow diagram on the derivation of the cell banks with details on cell concentration, volume, and the number of aliquots prepared. In addition, a tabulated summary of the specifications, and results of characterisation and testing performed on the cell banks could be provided. Controls of critical Steps and Intermediates (name, manufacturer) Critical Steps Tests and acceptance criteria (with justification including experimental data) performed at critical steps of the manufacturing process to ensure that the process is controlled should be provided. This information should be provided in detail. A summary of critical manufacturing steps, process controls performed, and acceptance criteria should also be provided. A discussion of the process control(s) selected for each critical manufacturing step and justification of the proposed acceptance criteria should also be provided. Process Validation and/or Evaluation (name, manufacturer) Process validation and/or evaluation studies for aseptic processing and sterilisation should be included. Sufficient information should be provided on validation and evaluation studies to demonstrate that the manufacturing process (including reprocessing steps) is suitable for its intended purpose and to substantiate selection of critical process controls (operational parameters and in-process tests) and their limits for critical manufacturing steps (e.g., cell culture, harvesting, purification, and modification). The information provided in the study report should support the current manufacturing process proposed for commercial use, including data to demonstrate consistency in yield and production, and degree of purity. The validation study report for the extent of  
Guidance for Industry Central Drugs Standard Control Organization Page 157   reuse and regeneration of columns and membranes should be provided, including in-process test results and data from relevant manufacturing batches, to demonstrate consistency in the quality and safety of the drug substance during production. The suitability of any proposed reprocessing procedures should be described and the criteria for reprocessing of any intermediate or the drug substance should be discussed. If adjuvants are added to the drug substance, information and data from the adsorption and desorption study should be submitted. Manufacturing Process Development (name, manufacturer) The developmental history of the manufacturing process, should be provided. The description of change(s) made to the manufacture of drug substance batches used in support of the marketing application (e.g., nonclinical or clinical studies) should include, for example, changes to the process or to critical equipment. The reason for the change should be explained. Relevant information on drug substance batches manufactured during development, such as the batch number (and subsequential drug product batch numbers), manufacturing date, scale, and use (e.g., stability, nonclinical, reference material) in relation to the change, should be provided. The significance of the change should be assessed by evaluating its potential to impact the quality (e.g. biological activity, impurity profile) of the drug substance (and/or intermediate, if appropriate). For manufacturing changes that are considered significant, data from comparative analytical testing on relevant drug substance batches should be provided to determine the impact on quality of the drug substance. A discussion of the data, including a justification for selection of the tests and assessment of results, should be included. Testing used to assess the impact of manufacturing changes on the drug substance(s) and the corresponding drug product(s) can also include nonclinical and clinical studies. A cross-reference to the location of these studies in other sections of Module 3 (e.g. Stability, Control of Drug Substance or Drug Product) and/or in other modules of the submission should be included.  
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