Hold time study

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 Likes

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

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

2 Likes