Which regulatory guidance is relevant to Hold Time Studies?

Written question

Which regulatory guidance is relevant to Hold Time Studies?

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Answer

WHO Technical Report Series 992, Annex 4 (2015), titled "General guidance on hold-time studies," is an important reference for designing and evaluating Hold Time Studies. In Bangladesh, the applicable DGDA requirements and the pharmaceutical company's approved GMP procedures should also be followed.

Explanation

Remember the organization, report number, annex, and document title. Verify the current applicable regulatory requirements when preparing a compliance response.