Pharmaceutical Good Manufacturing Practice Regulations Article 111
Manufacturers shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination.This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.Manufacturers shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded
中文原文 藥物優良製造準則第111條
製造業者應建立產品防護之書面程序或作業說明，以確保產品在內部處理和交運到預定地點期間之符合性。
該等防護應包括鑑別、搬運、包裝、儲存與保護。
產品之組成部分應適用防護之規定。
製造業者應建立書面程序或作業說明，以管制有架儲期限或特殊儲存條件要求之產品，該等特殊儲存條件應予以管制並記錄。
該等防護應包括鑑別、搬運、包裝、儲存與保護。
產品之組成部分應適用防護之規定。
製造業者應建立書面程序或作業說明，以管制有架儲期限或特殊儲存條件要求之產品，該等特殊儲存條件應予以管制並記錄。