Cmc Agreement

Once these performances have been identified, the format and content should be agreed. A truncated checklist for drug documentation can be found in Figure 1. The documentation obligations of the contractor and the sponsor of the file must be clearly defined. A written file regulation strategy is important and should include the amount of stability data included in the file (number of batches, storage conditions, months of storage, packaging configurations, bracketing/matrixing to be used), the release data to be included (number of batches, batch sizes), parameters analyzed for validation of the analysis method and the information to be included in the file. This strategy can be developed by the sponsor or in collaboration with the advisor. Responsibility for the preparation, verification, formatting, compilation and hypertext of submission documents should be clearly assigned. As the documentation of its system may not have an appropriate format or detail for direct submission to regulatory authorities, the standard documents should be checked to ensure that the documents provided comply with expectations. If the information relating to the submission needs to be reformatted, responsibility for this activity should be clearly assigned. It is strongly recommended that all agreements or contracts require manufacturing and/or development companies to review CMC`s final records to ensure that they accurately describe the procedures used by their company. This activity should be coordinated through its Regulatory Affairs or Quality Department. In addition, the draft dossier should be reviewed by a regulatory expert.