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A Brief Introduction about Data Management Platforms (DMP

                                               
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  • Which stability protocol should be used for long-term studies?
  • The stability protocol used for long-term studies for the stability commitment should be the same as that for the primary batches, unless otherwise scientifically justified. 2.1.9. Evaluation
  • How many batches of a drug should be used for photostability testing?
  • Photostability testing should be conducted on at least one primary batch of the drug product if appropriate. The standard conditions for photostability testing are described in ICH Q1B. 2.2.3. Selection of Batches Data from stability studies should be provided on at least three primary batches of the drug product.
  • What data should be provided from formal stability studies?
  • Data from formal stability studies should be provided on at least three primary batches of the drug substance. The batches should be manufactured to a minimum of pilot scale by the same synthetic route as, and using a method of manufacture and procedure that simulates the final process to be used for, production batches.
  • When should stability testing be conducted?
  • Stability testing should be conducted on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any secondary packaging and container label).
  • Why is trending of stability data important?
  • Stability data shelf life of DP. Therefore, the trending of all stability data is very important. Most be a linear, quadratic, or cubic function. sects the acceptance criterion (26,27). The tended change that may impact the DP. sive and time consuming. T o reduce resources required (6,7). ICH Q1A (R2) to when reduced testing is applied.
  • Should photostability testing be an integral part of stress testing?
  • Photostability testing should be an integral part of stress testing. The standard conditions for photostability testing are described in ICH Q1B. Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures.