藥廠采購和QAQC如何購買質量好的培養(yǎng)基？
發(fā)布時間：
2022-12-24
作者：
2018年7月15日，國家藥品監(jiān)督管理局發(fā)布通告指出，某生物科技有限公司凍干人用狂犬病疫苗生產(chǎn)存在記錄造假等行為。2018年7月16日，某生物科技公司發(fā)布公告，表示正對有效期內所有批次的凍干人用狂犬病疫苗全部實施召回;7月19日，某生物科技公司公告稱，收到《吉林省食品藥品監(jiān)督管理局行政處罰決定書》。2018年7月22日，國家藥監(jiān)局負責人通報違法違規(guī)生產(chǎn)凍干人用狂犬病疫苗案件有關情況。現(xiàn)已查明，企業(yè)編造生產(chǎn)記錄和產(chǎn)品檢驗記錄，隨意變更工藝參數(shù)和設備。上述行為嚴重違反了《中華人民共和國藥品管理法》《藥品生產(chǎn)質量管理規(guī)范》有關規(guī)定，國家藥監(jiān)局已責令企業(yè)停止生產(chǎn)，收回藥品GMP證書，召回尚未使用的狂犬病疫苗。
最近的不合格疫苗事件引起國人的拍案聲討，因為這關系著民生的健康，尤其是新一代的生命安全問題。對于事件中所牽扯的人和發(fā)生的具體原因再去追究已經(jīng)無濟于事，事實是大批的受害兒童和潛在的危機正在發(fā)生。這足以引起每一家制藥廠的重視，無論從采購，檢測，生產(chǎn)，質檢，還是運輸，環(huán)境還是售后，都要層層把關。下面小編就從制藥廠采購環(huán)境檢測用的產(chǎn)品微生物培養(yǎng)基的一個細節(jié)來說明，藥廠采購和QAQC如何購買質量好的培養(yǎng)基？
第一，選擇大品牌生產(chǎn)廠家。知名企業(yè)的責任心和生產(chǎn)的產(chǎn)品相對來說還是挺靠得住的。就像上過cctv的品牌在人們心目中一定是知名的，好的一樣。大品牌知名企業(yè)已經(jīng)在實踐中試過很多錯，吃過很多虧，對于好產(chǎn)品的定義，自然比小企業(yè)優(yōu)秀。為了提高競爭力，他們必將遵循“沒有最好，只有更好”，才能將品牌化道路走得更遠。就比如我們要購買日常用品，現(xiàn)在超市都是品牌陳列，對于陌生的未知的產(chǎn)品，我們心里也會打個問號。更何況是跟食品醫(yī)藥安全息息相關的生產(chǎn)環(huán)境檢測的培養(yǎng)基產(chǎn)品。
第二，一定要樣品測試和驗廠。一般廠家來說，為了擴展市場，依據(jù)產(chǎn)品的屬性，都會有一定量的試用產(chǎn)品，可以更好的在實驗室里通過驗證，眼見為實，讓產(chǎn)品使用人員切身實際看到想要的效果。測驗合格之后，就要去生產(chǎn)廠里實際驗廠，從人員配備，生產(chǎn)環(huán)境，到資格認證，技術支持，甚至是該公司的物流系統(tǒng)，客服系統(tǒng)，培訓等都要做系統(tǒng)全面的了解。從而為后期良好的產(chǎn)品供應做足充分的準備。
第三，多家對比，兩手都要準備。作為制藥廠的環(huán)境檢測方面，在選擇一家優(yōu)質的培養(yǎng)基生產(chǎn)企業(yè)之后，還需要選定一家備選，以防出現(xiàn)突發(fā)事件可以及時替換。所以一般藥廠會在知名企業(yè)采購大多數(shù)，而在備選廠家中購買一小部分產(chǎn)品。這也是在實踐中得到的經(jīng)驗，以免因為采購的延誤而導致自己的品牌受損。所以，在貨比三家的基礎上，備選一家培養(yǎng)基生產(chǎn)公司，是非常有必要的。
今天小編來推薦另一家品質和服務做的好的微生物培養(yǎng)基生產(chǎn)廠家——青島日水生物。理由有以下幾個：
產(chǎn)品質量過硬，按照標準品配方，國標GMP潔凈生產(chǎn)環(huán)境，品質有保證；
價格實惠。不追求暴利，細水長流在良好的客商關系中謀求發(fā)展；
服務好，口碑好。在實際供應過程中出現(xiàn)的客戶要求都能一一滿足，哪怕是一個發(fā)票的快遞追蹤，都及時跟蹤服務，在客戶心里打下了良好的口碑；
實力過硬。在8年的實踐路上，不斷試錯和改進，致力于開發(fā)滿足客戶需求的合格產(chǎn)品。
好了，相信看了這么多，無論是制藥廠的采購還是中間商經(jīng)銷商，都能很好的采購合格又價格美好的培養(yǎng)基。
How can pharmaceutical factories purchase and QAQC buy good quality media?
On July 15, 2018, the State Drug Administration issued a circular pointing out that the production of freeze-dried rabies vaccine for human use by a biotechnology company was fraudulent. On July 16, 2018, a biotechnology company announced that it was recalling all batches of lyophilized rabies vaccine for human use within the validity period; on July 19, a biotechnology company announced that it had received the "Decision on Administrative Penalties of Jilin Food and Drug Administration". On July 22, 2018, the person in charge of the State Drug Administration notified the case of illegal production of lyophilized rabies vaccine for human use. It has been found that enterprises make up production records and product inspection records, and change technological parameters and equipment at will. These actions seriously violate the relevant provisions of the Drug Administration Law of the People's Republic of China and the Standards for the Quality Control of Drug Production. The State Drug Administration has ordered enterprises to stop production, withdraw GMP certificates and recall rabies vaccines that have not yet been used.
Recent cases of unqualified vaccines have attracted a lot of criticism from the Chinese people, because they are related to the health of the people's livelihood, especially the safety of the new generation. It is no longer helpful to trace back to the people involved and the specific causes of the incidents. The fact is that a large number of child victims and potential crises are occurring. This is enough to attract the attention of every pharmaceutical factory, whether from procurement, testing, production, quality inspection, or transportation, environment or after-sales, have to be checked layer by layer. The following small edition from the pharmaceutical factory procurement of environmental testing products for microbial media for a detailed description of the pharmaceutical factory procurement and QAQC how to buy a good quality medium?
First, choose a large brand manufacturer. The sense of responsibility of well-known enterprises and the products produced are relatively reliable. Just like the brand that has been on CCTV, it must be well-known in people's mind. Big brands and well-known enterprises have tried many mistakes and suffered many losses in practice. The definition of good products is naturally better than that of small enterprises. In order to improve their competitiveness, they will follow the "no best, only better" to brand the road further. For example, we want to buy daily necessities, supermarkets are now brand display, for strange unknown products, our hearts will be a question mark. What's more, it is a culture product that is closely related to food and medical safety.
Second, we must test samples and inspect factories. Generally speaking, in order to expand the market, according to the attributes of the products, there will be a certain number of trial products, which can be better verified in the laboratory, see for real, so that the product users see the desired effect personally. After the test is qualified, we have to go to the actual factory, from staffing, production environment, to qualification certification, technical support, and even the company's logistics system, customer service system, training, etc. to do a comprehensive understanding of the system. So as to provide adequate preparation for later good product supply.
Third, many comparisons should be made with both hands. As for the environmental testing of pharmaceutical plants, after selecting a high-quality medium production enterprise, it is necessary to select an alternative to prevent emergencies can be replaced in time. So the general pharmacy will purchase most of the well-known enterprises, and in the alternative manufacturers to buy a small number of products. This is also the experience gained in practice, so as not to cause damage to its brand due to the delay in procurement. Therefore, on the basis of goods ratio three, it is very necessary to select a medium production company.
Today Xiaobian to recommend another quality and better service of microbial media manufacturers - Qingdao Rishui Biology. The reasons are as follows:
The quality of products is excellent, according to the standard formula, the national standard GMP clean production environment, the quality is guaranteed;
The price is substantial. We should not pursue huge profits, but we must strive for development in good customer relations.
Good service and good reputation. In the actual supply process, the customer requirements can be met one by one, even if it is an invoice tracking, are timely tracking service, in the customer's mind has laid a good reputation;
Excellent strength. In the 8 years of practice, we constantly try, make mistakes and improve ourselves, and are committed to developing qualified products to meet customers' needs.
Well, I believe that after watching so many, whether it is pharmaceutical factory procurement or dealers, can be very good procurement of qualified and good price culture medium.