Primary packaging materials pdf
intended to outline general requirements also applicable to other types of packaging materials or to properties of the container closure system, e. g. performance. The guideline is limited to plastic immediate packaging materials, i. e. packaging materials intended to be in direct contact with the active substance or medicinal product.Primary packaging solutions should emphasize both utility and appearance. Utility is important because if the packaging is defective, it may directly impact the end users ability to use your product. primary packaging materials pdf
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International
The international standard Quality management systems Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001: 2000, with reference to Good Manufacturing Practice (GMP) is a German initiative that will help the standardization of manufacturing primary packaging materials. Primary packaging materials are those that are in direct contact with the product (1). packaging process All operations, including lling and labelling, that a bulk product has to undergo in order to become a nished product (1). production primary packaging materials pdf 2 Chapter 15 Inspection, Labeling, and Packaging Objectives The final phases of drug product manufacturing consist of a physical inspection of the primary product container and the liquid or lyophilized drug product within the container.
The primary and secondary packaging of pharmaceutical products is closely linked to their production and constitutes an integral part of the valueadded process. The quality control unit is responsible for the control of pharmaceutical packaging materials including their receipt, identification primary packaging materials pdfRating: 4.64 / Views: 705