What is ISO15378 system certification
The background of the standard:
Drugs, since the emergence of human beings began to exist in the world, which shows its importance to human health and survival. Similarly, as the carrier (container) of drugs from the ancient "gold", "wood" to the modern society of plastic, composite materials and glass ceramics, because they have direct contact with the content, the health and quality safety requirements of drug packaging materials are as important as the requirements of drugs, can not be ignored! In the 1970s, blood transfusion caused more than 400 cases of sepsis in the United States. After investigation, it was found that the main causes of the accident were: the late contamination of drugs due to incomplete sealing of packaging; In 2008, ciwujia injection produced by a pharmaceutical company in northeast China also caused a drug accident after the liquid was contaminated due to the incomplete sealing of the package...
In order to regulate the control of pharmaceutical packaging materials in the production process and improve the quality of pharmaceutical packaging materials, the international Organization for Standardization (ISO) drafted and successfully promulgated the quality management system of pharmaceutical packaging materials control in 2006 -- ISO 15378 standard. With the continuous improvement and update, the latest version of the standard has been implemented in 2015, namely ISO 15378:2015. The implementation of the new standard not only points out the direction for pharmaceutical packaging material manufacturers to produce high-quality products, but also provides a more comprehensive evaluation basis for pharmaceutical packaging materials procurement by pharmaceutical manufacturers.
ISO 15378:2015 International standard for pharmaceutical internal packaging materials
International Organization for Standardization (ISO),ISO for short, is a global ngo, is a very important Organization in the field of International Standardization. It promulgated ISO 15378:2015 standard, aiming to sell pharmaceutical packaging materials from different countries and regions around the world, a review, universal.
The ISO 15378:2015 standard is based on THE FRAMEWORK of ISO 9001 and integrates the requirements of THE US FDA good Manufacturing Practice for pharmaceutical products. It provides manufacturers of pharmaceutical packaging materials with: It defines the management requirements (quality management system) and hardware requirements (plant, production site, equipment, etc.) of pharmaceutical packaging material manufacturers. Procurement and use of raw materials/packaging materials, hygiene and quality control in the manufacturing process, personnel hygiene management, product inspection, disposal of quality abnormalities, product complaints and recalls, etc.
It can be seen that the approval of international PHARMACEUTICAL packaging ISO 15378:2015 is not only a prerequisite for smooth export of enterprises, but also a requirement for standardized management of domestic pharmaceutical packaging manufacturers, and an important guarantee for the promotion of "soft power" of pharmaceutical packaging manufacturers.
The implementation of ISO 15378:2015 has the following advantages:
Comply with international pharmaceutical regulations to ensure product safety
It is the prerequisite for enterprises to gain the trust of buyers smoothly and can improve the company's product quality management level
Reduce the risk of injury or death to consumers and protect their use
The only way of industry development, eliminate dangerous accidents
Reduce the risk of public recall of products
Effective cost control and international recognition
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