We go to the audit
Release time:
2020-07-22
We went to audit
# May 17 -19 . As a member of the supplier audit team, I visited Changzhou Ruiming, Wuxi Yangjian Huaqiang, Suzhou Haishun, Zhejiang Duoling Pharmaceutical Packaging and other companies with my colleagues and conducted a series of audit work.
As one of the key elements of production, the quality and stability of raw materials and auxiliary materials directly determine the stability of the final product quality. In order to ensure the stability of product quality, our manufacturers conduct supplier audits of raw and auxiliary package suppliers every year. This is an on-site audit, including verifying the authenticity of the supplier's qualification documents and inspection reports, whether they have inspection conditions, etc., as well as reviewing its personnel structure, plant facilities and equipment, material management, production process and production management, and quality control laboratory equipment, instruments, document management, etc.
This is my first time to participate in the audit, although I made a corresponding inspection plan for the basic situation of all the suppliers to be inspected before departure. However, once you arrive at the scene, you will still be nervous and do not know where to start. With the warm reception of the representatives of the supply side, our audit work was carried out in an orderly manner.
First of all, we went to the manufacturers of raw materials and chemical raw materials. Before entering the production area, the reception staff of the other party gave us full oral safety education and issued safety helmets, demonstrating the safety awareness that a chemical plant should have. Their production area and office area have obvious regional isolation, effectively avoid cross-contamination. However, some parts of the production site are not doing very well. For example, the unloading position of the raw materials delivered from the warehouse is too random, which is just the place where solar energy is exposed. The label of the raw materials during feeding was removed in advance. In contrast, our factory has done a better job of on-site management. When the raw materials come, there will also be a special unloading position. The labels of the materials will be on the materials until the end of feeding, so as to avoid confusion. We raised these issues with the manufacturer, and the other party accepted them modestly, dealt with them in a timely manner, and said that they would provide rectification reports after all rectifications.
may be an old customer. The manufacturers of composite film (bag) and aluminum foil for drug packaging are a little too casual in reception. We arrived at the factory on the same day but could not find the reception staff. On the spot, there is a sharp contrast between the packaging material manufacturers and our pharmaceutical companies. Although they are also in the D area, their spot is slightly messy and their concept of clearing the spot is somewhat vague. Due to continuous production, the equipment site is easy to leave materials, and the lack of fixed position is slightly messy. They also made rectification immediately after the site was put forward. For our pharmaceutical factory, it is also necessary to change what we have and encourage what we have not.
The third enterprise we went to is a large listed company. Not only can the production and inspection equipment meet the production and inspection requirements, but also the production line is fully automatic production of industry 4.0 , which is fully automated from equipment operation, material and product transportation. In the workshop, the quality of products is also monitored in real time through the central control room, and the positioning of various items is also standardized. The warehouse is a 4 -storey three-dimensional library, which realizes unmanned operation. Their laboratory even has a separate aluminum plastic machine to do challenging experiments, reflecting their pursuit of product quality excellence. All these are worth learning. The wave of industrial automation upgrading is constantly advancing. Although we have not yet entered that stage, we must always maintain our own improvement to meet this wave.
The last company is an enterprise that produces PVC medicinal hard tablets and various composite hard tablets and composite high-barrier packaging materials. Our host is their QC supervisor. To my surprise, their supervisor QC was born in a health school and took part in the inspection work, but he was quite familiar with their process flow and process parameters. This also makes us realize that no matter what position we are in, we should actively learn what we can come into contact with, especially for the process flow and process parameters in production, showing a kind of professionalism for our own industry. During the audit, we found that their workshop also has a special access to visit, each door has access control, for access control is very good. This is where we can learn from. For a workshop, access control is very important, which can effectively avoid problems such as personnel stringing and pollution.
As a production enterprise, our pharmaceutical factory also accepts the audit of our customers every year. Through this rare audit opportunity, I can look at the supplier from the customer's point of view, from which I can objectively see many problems in daily work and production. The first point is that for the reception of customers, special personnel and sufficient relevant information can make customers have a good impression on us; on the production site, various small details determine the quality of the product and whether the production process meets the customer's standards; records and various inspection reports show the true quality of the product. Taking the essence and removing the dross, we will apply the experience gained during this audit to our daily production work, which will certainly give a great impetus to our future work. (Zheng Nan)
More information
Publicity of Environmental Protection Acceptance for Completion of Kiln End Flue Gas Desulfurization Project of daye peak cement co., ltd. According to the requirements of the Interim Measures for Environmental Protection Acceptance for Completion of Construction Projects (No.4 [2017] of the State Environmental Regulations) issued by the Ministry of Environmental Protection, the environmental protection acceptance information of "Kiln End Flue Gas Desulfurization Project" of daye peak cement co., ltd. is now publicized. Basic Information of 1. Project Project Name: Kiln End Flue Gas Desulfurization Project Construction Unit: daye Jianfeng Cement Co., Ltd. Project Construction Location: Yongguang Village, Baoan Town, daye city, nature of the project in the existing plant area of daye Jianfeng Cement Co., Ltd.: The construction content of the technological transformation project is: This technological transformation project is mainly to build a wet desulfurization system for kiln end gas of the company's existing 4000t cement clinker production line, adopting limestone-gypsum wet flue gas desulfurization process. The project covers a total area of 500 m2, with a new construction area of about 450 m2. It mainly builds desulfurization complex building, flue gas system, SO2 absorption system, limestone powder conveying and limestone slurry preparation system, process water system, gypsum dehydration system and supporting pipelines. Power supply, water supply, compressed air and other public works rely on the existing plant. Total investment and environmental protection investment: the total investment of the project is 10.37 million yuan, all of which are environmental protection investment. The project was entrusted to Huangshi Yangtze River Environmental Engineering Design and Research Institute to carry out environmental impact assessment in September 2017. On November 16, 2017, Daye Municipal Environmental Protection Bureau issued a reply with YEHAN [2017] No. 354. Implementation of 2. environmental protection measures The scope of this acceptance is the flue gas desulfurization system and supporting facilities at the end of the kiln. (1) Exhaust gas pollution
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31