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about GMP Certification
The Chinese meaning is "product quality management standards" or "good manufacturing standards", which is an autonomous management system that pays special attention to the implementation of product quality and health safety in the production process.
According to Decree No. 79 of 2011 signed by the Minister of Health of the People's Republic of China, "Standards for Quality Control of Drug Production (Revised in 2010)" (hereinafter referred to as the new version of GMP) has been considered and approved by the Ministry of Health on October 19, 2010, and has been in effect since March 1, 2011. In the new version of GMP, the new concept of quality risk management is introduced in time. For example, it clearly requires enterprises to establish quality management system, introduce risk management in quality management, and emphasize that the implementation of GMP should be based on science and risk. A series of new systems have been added, such as supplier audit and approval, change control, deviation management, OOS investigation, corrective and preventive measures (CAPA), continuous stability inspection plan, product quality review and analysis, etc. Secondly, the new concept of quality management system is introduced. The new GMP clearly requires pharmaceutical enterprises to establish a comprehensive, systematic and rigorous quality management system, and must be equipped with sufficient resources, including human resources and management system to ensure the effective operation of the quality system.
The contents of the new GMP clause are more specific, more instructive and more operable, and the regulations in terms of production conditions and management system are more comprehensive and specific, which further ensures the safety, stability and uniformity of drug quality from the production links.
In view of our company's anti-biotic bottle caps, oral liquid aluminium plastic caps, pull ring aluminium plastic caps and other aluminium plastic combination caps, as well as matching antibiotic bottles, oral liquid control bottles, thread mouth bottles and other controlled glass bottles, ampoules products, mainly facing pharmaceutical factory customers, in order to meet the requirements of pharmaceutical factory customers, since the commissioning of production has been guided by GMP standards, with the national standards for pharmaceutical packaging materials as the quality standards, Take the customer service as the center, make the operation standard, the product conforms to the standard, and is strict with the standard, the quality is guaranteed, and the service is tracked. Let our customers feel at ease, at ease, and confident in our products.
Guideline for the Manufacturing Quality Management of Pharmaceutical Packaging Materials
Summary of knowledge about pharm package