Guidelines for the Quality Management of Pharmaceutical Packaging Materials

The China Pharmaceutical Packaging Association group standard “Guidelines for the Quality Management of Pharmaceutical Packaging Materials” (T / CNPPA 3005-2019) was published on May 8, 2019, and will be implemented from May 8, 2019.

At present, most pharmaceutical packaging materials companies comply with the requirements of ISO15378 to establish relevant production quality management systems.

As a pharmaceutical company, it has established a production quality management system in accordance with the requirements of pharmaceutical GMP. 

The two systems have different concerns about content and requirements. Therefore, in the process of auditing and daily communication, unnecessary errors are caused by both parties.

This standard is to apply the principles of pharmaceutical GMP and ISO9001 to pharmaceutical package enterprises and refers to the specific requirements of the pharmaceutical primary packaging material production quality management specification (ISO15378).

This standard is based on the requirements of ISO15378, using GMP language to describe the relevant clauses, so that packaging materials companies and pharmaceutical companies can fully understand the requirements of this standard and can implement it correctly. This standard is to regulate the production management of packaging materials like pharmaceutical collapsible aluminum tubes, ointment collapsible aluminum tubes, pharmaceutical aluminum squeeze tubes and etc. establish a production quality management system for pharmaceutical packaging materials, and ensure the product quality of pharmaceutical packaging materials and their intended applicability (including protection, functionality, safety, compatibility). 

This standard can be used for internal or external certification of pharmaceutical packaging material manufacturers and customer contract purposes, and can also be used by pharmaceutical companies to perform audits of pharmaceutical packaging material suppliers.

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