HOLD-TIME STUDY FOR PHARMACEUTICAL TABLET DURING MANUFACTURING PROCESS: AN INNOVATIVE STEP

  • Shaziya Yasmeen Sayeed Department of Quality Assurance Bhupal Nobles’ Institute of Pharmaceutical Sciences, Udaipur, Rajasthan, India
  • Anju Goyal Department of Quality Assurance Bhupal Nobles’ Institute of Pharmaceutical Sciences, Udaipur, Rajasthan, India

Abstract

 

 Objective: The objective of the study was to ensure that intermediates and the bulk product can be held without any significant adverse effect on the quality of the material till next step of processing. Such a holding period should be based on data. Studies should not be extended to find the edge of failure for holding.

Method: Samples are put away in same natural conditions as in manufacturing/storage. After establishing a sampling plan required sample amount based on the batch size is ascertained, the intervals and tests are to be performed. Samples are kept in a storage container and tested. Results are contrasted and the underlying benchmark information of the control test. Hold-time study data shall give the assurance the maximum allowable hold times for bulk and in-process drug products. In general, one lot can be used for validating hold times if any irregularity comes, results were observed then another two lots can be used for this investigation.

Conclusion: Each manufacturing stage shelf life can be determined depending on the hold-time study results. If the hold-time samples are passing at 60-day time point, then the shelf life of the specific stage can be considered up to 45 days.

Keywords: Pharmaceutical manufacturing, Hold-time process, Tablet manufacturing, Coated tablets, Shelf life, Quality of the pharmaceutical product.

References

1. Supplementary Guidelines on GMP: Validation, Non-Sterile Process Validation. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: Forty-Ninth Report. Geneva: WHO; 2015: Annex 3 (WHO Technical Report Series, No. 992).
2. Agalloco JP, Carleton FJ. Validation of Pharmaceutical Processes. 3rd ed. New York: Information Healthcare; 2007. p. 444-6.
3. Pawar DP, Shamkuwar PB, Chavan SS. Hold time study of Cetirizine di hydrochloride lubricated granules. Asian J Pharm Clin Res 2012;5 Suppl 4:234-6.
4. Huma A, Khatri AM, Jain A, Modi R, Pate A. Standard practice of sampling, storage and holding time for pharmaceutical tablet and injection during manufacturing process. Drug Invent Today 2011;3:157-9.
5. Pawar DP, Shamkuwar PB, Hosmani AH. Hold time study for pharmaceutical binders, lubricated granules, compressed tablets, coating suspension and coated tablets during manufacturing process. Pharm Sin 2012;3:300-4.
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How to Cite
Sayeed, S. Y., and A. Goyal. “HOLD-TIME STUDY FOR PHARMACEUTICAL TABLET DURING MANUFACTURING PROCESS: AN INNOVATIVE STEP”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 11, no. 1, Jan. 2018, pp. 427-30, doi:10.22159/ajpcr.2018.v11i1.22669.
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Original Article(s)