Hold time study

Validation
1

1.what is the criteria for performing of hold time study. 2.How batch size(increase/decrease) effect on hold time study on product.
3.what is head space and how that will effect on hold time study of product.

2

https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex4-TRS992.pdf?ua=1

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3

Tq awad,But Annex4 TRS992 having only oral solids hold time, which guidelines explain injectable hold time.

4

There is no detailed guidelines for injectables hold time studies, only scientific paper as that quoted

However 2020 Draft EU Annex 1 mentioned these issues

https://www.gmp-compliance.org/guidemgr/files/2020_annex1ps_sterile_medicinal_products_en.pdf

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