關于沙氏葡萄糖瓊脂培養基即用型產品效期變更公函
發布時間：
2022-11-16
作者：
國產生物培養基日水生物
青島日水生物技術有限公司 公函圖片
尊敬的新老客戶，
針對我公司內容物為沙氏葡萄糖瓊脂培養基（SDA）的即用型產品的效期，經多次反復驗證后做出相關調整，效期由原來的90天變更為180天。
1，產品生產工藝和生產過程質控方法、配比、包材、容器、儲藏條件等情況沒有發生任何變化，質量標準更加嚴格。
2，產品穩定性實驗按照原指控標準的穩定性試驗方案進行。
3，對質量標準、說明書、包裝標簽等部分相關內容進行修訂。
我司針對此類產品的適用性檢查、儲存條件、效期等均作了相關驗證。同時跟蹤同一產品的三個批次，檢驗結果表明：在新的效期內產品的適用性檢查、無菌性、理化參數等各項 指標均符合相關標準的要求。因此，我司針對此類產品的效期做出以上調整。在此聲明執行之前的產品效期仍按原效期執行。
特此聲明
為此，給新老客戶帶來的諸多不便敬請諒解。
青島日水生物技術有限公司
2017.04.20
Respectful old and new customers,
According to the effect period of the product of SDA, the content of our company was adjusted repeatedly after repeated verification, the effect period was changed from 90 days to 180 days.
1, the quality control method, the ratio, the material, the container, the storage condition of the production process and the production process have not changed, and the quality standard is more strict.
2, the product stability test is carried out according to the stability test scheme of the original accusation standard.
3, the quality standards, manuals, packaging labels and other related contents should be revised.
Our company has made relevant verification on the applicability inspection, storage conditions and validity period of such products. Three batches of the same product were tracked at the same time. The test results showed that the applicability of the products, aseptic and physical and chemical parameters in the new period were in conformity with the requirements of the relevant standards. Therefore, our company has made the above adjustment for the product's validity. The product validity period before execution is still executed according to the original period.
This is hereby declared
For this reason, please forgive me for the inconvenience brought to new and old customers.