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Guideline for the Manufacturing Quality Management of Pharmaceutical Packaging Materials

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[Abstract]:
Based on ISO 15378-2017, Taian Youlyy has deepened and learned the standards of " Guideline for the Manufacturing Quality Management of Pharmaceutical Packaging Materials ", so as to make the company

 

Guideline for the Manufacturing Quality Management of Pharmaceutical Packaging Materials

The group standard of China National Pharmaceutical Packaging Association  " Guideline for the Manufacturing Quality Management of Pharmaceutical Packaging Materials " (T/CNPPA 3005-2019) has been issued on May 8, 2019 and has been implemented since May 8, 2019.

At present, most pharmaceutical packaging materials enterprises comply with the requirements of ISO15378-2017 to establish relevant production quality management system.As a pharmaceutical company, it has established a production quality management system according to the requirements of GMP.These two systems have different concerns in contents and requirements, therefore,unnecessary errors are caused in the process of auditing and daily communication.

The standard applies the principles of GMP and ISO9001 to pharmaceutical packaging materials enterprises, and refers to the specific requirements of the production quality control standard of primary packaging materials for pharmaceuticals (ISO 15378-2017).

The standard is based on the requirements of ISO15378-2017, and adopts the language of GMP to describe the relevant provisions, to make both pharmaceutical packaging enterprises and pharmaceutical enterprises fully understand the requirements of this standard, and implement it correctly.The purpose of this standard is to standardize the production management of pharmaceutical packaging materials, establish the production quality management system of pharmaceutical packaging materials, and ensure the product quality and intended applicability (including protection, functionality, safety and compatibility) of pharmaceutical packaging materials.

The standard can be used for internal or external certification of pharmaceutical packaging materials manufacturers, and also for reference by pharmaceutical enterprises when auditing suppliers of pharmaceutical packaging materials.

Based on ISO 15378-2017, Taian Youlyy has deepened and learned the standards of  " Guideline for the Manufacturing Quality Management of Pharmaceutical Packaging Materials ", so as to make the company more standardized and professional in production quality management and provide customers with safe, reliable and assured pharmaceutical packaging products.