Best Practice Guidelines for Pharmaceutical Secondary Packaging
First class quality coupled with consumer safety is the over-riding priority within the pharmaceutical sector; safe and effective packaging is a critical part of the value chain.
As the representative body for the folding carton industry, the European Carton Makers Association (ECMA), is releasing the Best Practice Guidelines for Pharmaceutical Secondary Packaging.
These guidelines document Best Practice from 'receipt of order to delivery to the customer' and encompass the latest technology. Those companies that are a direct member of ECMA and comply with the guidelines are demonstrating their rigorous work practices, dedication, and commitment to the Pharma & Healthcare sector.
The Best Practice Guidelines for Pharmaceutical Secondary Packaging is an information and management tool with a clear methodology based on the following principles: Senior Management sponsorship of compliance with the BEST PRACTICES standard AND a Quality Management System such as PS 9000 / ISO 9001 / ISO 15378 and/or a strict workplace hygiene control system is in place as the cornerstone quality benchmark.
More information can be obtained by contacting ECMA at firstname.lastname@example.org.
Self-declaration and compliance seal
Companies can issue a self-declared compliance statement for the manufacture of cartons for pharmaceutical Secondary Packaging.
The self-declaration form can be completed online by clicking here. The declaration should be completed and returned to the ECMA secretariat including copies of valid certificates (PS 9000 / ISO 9001 / ISO 15378 ...). In case of multiple locations, the declaration needs to be completed for each individual location, including the PS/ISO certificates for these locations). The self-declared compliant companies are listed on the ECMA website and are allowed to use the ECMA Best Practice Guidelines for Pharmaceutical Secondary Packaging compliance seal.
Check the list of self-declared Best Practice Guidelines for Pharmaceutical Secondary Packaging compliant ECMA members here.
As this ECMA developed compliance seal is self declared and voluntary, it may not be construed by any means as an approval or endorsement by ECMA of compliance with the Best Practice Guidelines for Pharmaceutical Secondary Packaging or with any applicable requirements, including the safety requirement, of cartons manufactured by companies using the seal.
The publication by ECMA of the list of self-declared compliant companies using the seal is not either to be construed as an approval or endorsement by ECMA. The use of the seal is made by each individual company under its sole responsibility, having due regard to the guidelines and the applicable legislation.