01 "plant facilities and equipment" published and distributed
Recently, by the State pharmaceutical Administration Food and pharmaceutical Administration Audit and Inspection Center for the organization of the preparation of the "pharmaceutical GMP Guide" (2nd edition) series of books published and distributed.
CHANSE Technology participated in the new chapter in the book "Plant Facilities and Equipment" - "Advanced Manufacturing" content writing, including: "Intelligent Information Platform", "Process Analysis Technology" and "Continuous Production".
With years of experience in the industry, the company's researchers strive to serve the new industrial pattern driven by knowledge and innovation, and elaborate the key performance of pharmaceutical equipment in the pharmaceutical process by refining the classic cases, which provides a more professional and efficient introduction to the pharmaceutical process and advanced technology for the majority of practitioners.
Strengthening the quality of pharmaceutical production and promoting the "advanced manufacturing" of pharmaceuticals is the key technology of the pharmaceutical equipment industry, cutting-edge leading technology for the forward exploration. Relying on the advanced process analysis technology (PAT), CHANSE has introduced and developed the continuous production line of "continuous manufacturing, data release" and developed the intelligent information platform independently, so as to improve the quality, reduce the cost and increase the efficiency of the pharmaceutical products in the production process.
As a total solution provider of pharmaceutical technology in China, CHANSE Technology actively provides pharmaceutical customers with "perfectly designed and carefully manufactured" process equipment, adheres to the safety and intelligence of pharmaceutical production, and hopes that the pharmaceutical industry can make greater contributions to the human society!
Preparation of the note
Since its publication in August 2011, the Pharmaceutical GMP Guide Series has played an important role in assisting China's pharmaceutical industry in learning, understanding and implementing the Good Manufacturing Practice (GMP). Additionally, it has served as a valuable resource for pharmaceutical GMP inspectors. Over the past decade, the quality management system of China's pharmaceutical industry has experienced continuous improvement, with a notable upgrade in the level of quality management, and the Pharmaceutical Administration Law, Vaccine Administration Law, Measures for the Administration of Pharmaceutical Registration, Measures for the Supervision and Administration of Pharmaceutical Manufacturing, and other laws and departmental regulations have been formulated and revised one after another, and a number of GMP appendices have been enacted and implemented to strengthen and improve the requirements for the implementation of pharmaceutical GMP. With the State Pharmaceutical Administration becoming a member of the ICH Management Committee, the national regulatory system for vaccines passing the World Health Organization's NRA assessment, and actively preparing to apply for membership in the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the internationalization of China's pharmaceutical regulation is deepening. In particular, the international pharmaceutical GMP guidelines have been continuously updated in the past decade, involving new concepts, standards and technologies such as data reliability, sterile products, continuous manufacturing, etc. , and there is an increasingly urgent need for the industry to update and revise the contents of the pharmaceutical GMP guideline series.
In August 2021, under the support and guidance of the State pharmaceutical Administration (SDA) and relevant departments and bureaus, the Food and Pharmaceutical Audit and Inspection Center of the State Food and Pharmaceutical Administration (SFDA), together with the Laboratory of Knowledge Engineering and Regulatory Science of Peking University (LKESRS), and the China Medical Science and Technology Publishing House (CMSTPH) of China Health Media Group (CHMG), organized the revision of the GMP Guidelines for pharmaceutical products.
Based on the content of the previous edition, the 2nd edition of the GMP Guidelines for Pharmaceuticals combines the specific practices of the domestic and international pharmaceutical industry from the past decade. It also incorporates key changes of the relevant guidelines of ICH, WHO, PIC/S, U. S. FDA, and EMA, as well as draws on the relevant guidelines of ISPE, ISO, PDA, and APIC, etc. , and aims to serve the knowledge-driven and innovation-driven development of the industry and the patient-oriented, risk-based and scientific supervision. risk-based scientific regulation.
Over 500 experts from more than 130 domestic and foreign pharmaceutical regulatory and supervisory authorities, manufacturing enterprises and research institutes actively participated in the reprint and revision work, and completed a manuscript of more than 5 million words, with the content nearly doubled compared with the previous edition.
About CHANSE
CHANSE Technology (Jiangsu) Co. , Ltd (hereinafter referred to as "CHANSE Technology") is a total solution provider of pharmaceutical technology, and the corporate motto of CHANSE Technology is: "Innovate, Pursue Excellence, Create Standards, Serve Customers". "CHANSE Technology operates in three primary business segments: pharmaceutical solid dosage forms, biologics and complex liquid dosage forms, and disposable biotechnology. Based on the equipment of "perfect design, elaborate manufacturing", the solid pharmaceutical preparation section actively provides a full set of technical support from process mapping, process optimization to process transfer and amplification for the majority of pharmaceutical customers; the biologics and complex liquid preparation section focuses on the biopharmaceutical, blood products and complex injection industry, adhering to the combination of process and engineering mode, and is committed to providing customers with the best service. The biologics and complex liquid preparations section focuses on the biopharmaceutical, blood products and complex injectables industries, and adheres to the model of process and engineering, and is committed to providing customers with the overall solution of the process system for the preparation of the stock solution and the production of the preparation; the disposable biotechnology section specializes in the research and development and production of clean and safe disposable biopharmaceutical use systems. Based on the leading technology, and taking "the deep integration of informationization and pharmaceutical technology" as the focus point, CHANSE has created the intelligent production line of "continuous manufacturing and data release" with the help of various advanced process analysis technologies (PAT) and self-developed intelligent production execution system (Smart MES). After more than 10 years of precipitation, the quality and performance of the equipment developed by CHANSE Technology has reached the international advanced level, and CHANSE Technology has more than 500 square meters of process laboratory, which can provide more than 200 different kinds of supporting process services every year. In recent years, CHANSE Technology has been working together with customers to develop comprehensive solutions for digitalization, informatization and intelligence in the pharmaceutical field, to meet the challenges of "Industry 4.0" and "Made in China 2025", and to help customers to develop their pharmaceutical manufacturing processes by virtue of advanced equipment performance, excellent process understanding and engineering advantages. With advanced equipment performance, excellent process understanding and engineering advantages, we help China's pharmaceutical industry to realize industrialization upgrading, cost reduction and efficiency.
Address：No.581 East Labor Road, Tianning District, Changzhou City, Jiangsu Province, China
Tel：0519-8550 5268
Fax：0519-8886 9251
E-mail: [email protected]
Zip code: 213000
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