How much Force degradation required as per guidelines?

No given over guidelines Q2R1 but british documentry say minimum 10 present required

how can Hold Time study in pharma industry ?

Pharmaceutical drug products stability Follow the guidelines are mentioned in ICH, FDA, EMEA and WHO guidelines.

If any inconsistency results observed then another two lots can be used for this study. Although there are no specific regulations or guidance documents on bulk product hold times, GMP dictates that hold times should be validated to ensure that in-process and bulk product can be held, pending the next processing step, without any adverse effect to the quality of the material. Hold time study provides the re-assurance of the quality at each in-process stages.

Hold Time Stability Study

Hold stability study can demonstrates how much time is suitable for hold the blend or bulk stage before processing to the next stage.

Hold time stability results meet the product specifications. Hold time study shall be carried out with the storage container packing’s only. If the dosage form is stored in bulk containers for over 30 days, real-time stability data under specified conditions should be generated to demonstrate comparable stability to the dosage form in the marketed package

Hold Time Stability Study Flow

Hold time studies use scale up commercial validation stages. Before scale up review flow of hold study has represented in In the pharmaceutical industry

• Selection of critical steps
• Hold study time points and tests;
•  Hold study protocol;
• Hold study analysis;
• Hold study report .
•  Hold study results evaluation.
• Hold Study Time day of calculated

Hold study time calculated are generally

Hours: 1, 3, 5, 7, 12, 24, 36, 48, 72 hours

Days: 1, 7, 15, 30, 45, 60, 75, 90 days

Hold Time Study Protocol

Hold time study protocol can be prepared on the basis of product manufacturing process of the drug product. The main contents in the protocol are, hold study stages, study time points and analytical tests.

Hold Time Study Results Evaluation

Every manufacturing shelf life perform based on the hold study results. If the hold time samples are passing at 60 days time then the shelf life of the particular stage can be considered up to 45 days.

Conclusion

Hold time study results are passing the 60 days time interval then 45 days limit is good for general practice. In the same way if the stage is passing the 72 hours interval then 48 hours limit is general practice. If not performed the hold study in the product development stage then in commercial level need to perform the hold study for first three commercial batches

Disclaimer

The purpose of this hold time study review is solely educational. This review article is built from authors work and experience.