關(guān)于沙氏葡萄糖瓊脂培養(yǎng)基即用型產(chǎn)品效期變更公函
發(fā)布時(shí)間：
2022-11-16
作者：
國(guó)產(chǎn)生物培養(yǎng)基日水生物
青島日水生物技術(shù)有限公司 公函圖片
尊敬的新老客戶(hù)，
針對(duì)我公司內(nèi)容物為沙氏葡萄糖瓊脂培養(yǎng)基（SDA）的即用型產(chǎn)品的效期，經(jīng)多次反復(fù)驗(yàn)證后做出相關(guān)調(diào)整，效期由原來(lái)的90天變更為180天。
1，產(chǎn)品生產(chǎn)工藝和生產(chǎn)過(guò)程質(zhì)控方法、配比、包材、容器、儲(chǔ)藏條件等情況沒(méi)有發(fā)生任何變化，質(zhì)量標(biāo)準(zhǔn)更加嚴(yán)格。
2，產(chǎn)品穩(wěn)定性實(shí)驗(yàn)按照原指控標(biāo)準(zhǔn)的穩(wěn)定性試驗(yàn)方案進(jìn)行。
3，對(duì)質(zhì)量標(biāo)準(zhǔn)、說(shuō)明書(shū)、包裝標(biāo)簽等部分相關(guān)內(nèi)容進(jìn)行修訂。
我司針對(duì)此類(lèi)產(chǎn)品的適用性檢查、儲(chǔ)存條件、效期等均作了相關(guān)驗(yàn)證。同時(shí)跟蹤同一產(chǎn)品的三個(gè)批次，檢驗(yàn)結(jié)果表明：在新的效期內(nèi)產(chǎn)品的適用性檢查、無(wú)菌性、理化參數(shù)等各項(xiàng) 指標(biāo)均符合相關(guān)標(biāo)準(zhǔn)的要求。因此，我司針對(duì)此類(lèi)產(chǎn)品的效期做出以上調(diào)整。在此聲明執(zhí)行之前的產(chǎn)品效期仍按原效期執(zhí)行。
特此聲明
為此，給新老客戶(hù)帶來(lái)的諸多不便敬請(qǐng)諒解。
青島日水生物技術(shù)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.