药厂采购和QAQC如何购买质量好的培养基?

发布时间:

2022-12-24

作者:


2018年7月15日,国家药品监督管理局发布通告指出,某生物科技有限公司冻干人用狂犬病疫苗生产存在记录造假等行为。2018年7月16日,某生物科技公司发布公告,表示正对有效期内所有批次的冻干人用狂犬病疫苗全部实施召回;7月19日,某生物科技公司公告称,收到《吉林省食品药品监督管理局行政处罚决定书》。2018年7月22日,国家药监局负责人通报违法违规生产冻干人用狂犬病疫苗案件有关情况。现已查明,企业编造生产记录和产品检验记录,随意变更工艺参数和设备。上述行为严重违反了《中华人民共和国药品管理法》《药品生产质量管理规范》有关规定,国家药监局已责令企业停止生产,收回药品GMP证书,召回尚未使用的狂犬病疫苗。
 
最近的不合格疫苗事件引起国人的拍案声讨,因为这关系着民生的健康,尤其是新一代的生命安全问题。对于事件中所牵扯的人和发生的具体原因再去追究已经无济于事,事实是大批的受害儿童和潜在的危机正在发生。这足以引起每一家制药厂的重视,无论从采购,检测,生产,质检,还是运输,环境还是售后,都要层层把关。下面小编就从制药厂采购环境检测用的产品微生物培养基的一个细节来说明,药厂采购和QAQC如何购买质量好的培养基
 
第一,选择大品牌生产厂家。知名企业的责任心和生产的产品相对来说还是挺靠得住的。就像上过cctv的品牌在人们心目中一定是知名的,好的一样。大品牌知名企业已经在实践中试过很多错,吃过很多亏,对于好产品的定义,自然比小企业优秀。为了提高竞争力,他们必将遵循“没有最好,只有更好”,才能将品牌化道路走得更远。就比如我们要购买日常用品,现在超市都是品牌陈列,对于陌生的未知的产品,我们心里也会打个问号。更何况是跟食品医药安全息息相关的生产环境检测的培养基产品。
 
第二,一定要样品测试和验厂。一般厂家来说,为了扩展市场,依据产品的属性,都会有一定量的试用产品,可以更好的在实验室里通过验证,眼见为实,让产品使用人员切身实际看到想要的效果。测验合格之后,就要去生产厂里实际验厂,从人员配备,生产环境,到资格认证,技术支持,甚至是该公司的物流系统,客服系统,培训等都要做系统全面的了解。从而为后期良好的产品供应做足充分的准备。
 
第三,多家对比,两手都要准备。作为制药厂的环境检测方面,在选择一家优质的培养基生产企业之后,还需要选定一家备选,以防出现突发事件可以及时替换。所以一般药厂会在知名企业采购大多数,而在备选厂家中购买一小部分产品。这也是在实践中得到的经验,以免因为采购的延误而导致自己的品牌受损。所以,在货比三家的基础上,备选一家培养基生产公司,是非常有必要的。
 
今天小编来推荐另一家品质和服务做的好的微生物培养基生产厂家——青岛日水生物。理由有以下几个:
 
产品质量过硬,按照标准品配方,国标GMP洁净生产环境,品质有保证;
价格实惠。不追求暴利,细水长流在良好的客商关系中谋求发展;
服务好,口碑好。在实际供应过程中出现的客户要求都能一一满足,哪怕是一个发票的快递追踪,都及时跟踪服务,在客户心里打下了良好的口碑;
实力过硬。在8年的实践路上,不断试错和改进,致力于开发满足客户需求的合格产品。
 
好了,相信看了这么多,无论是制药厂的采购还是中间商经销商,都能很好的采购合格又价格美好的培养基。
 

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.