Specific projects defined to develop Industry standards at ECMA Pharma Forum

Special interest platform within ECMA

The ECMA Pharma Forum is a special interest platform within ECMA for dedicated producers of pharmaceutical cartons. In the past, the forum has developed an industry standard for braille, which has turned into an industry wide accepted standard. After this success the forum looks for new ways to set industry standards to share their expertise with the rest of the industry supply chain. In 2017, the forum organised a strategy meeting. The outcomes of this meeting where very encouraging, but did not immediately lead to new projects. At the last meeting on 12 February 2019 specific projects where defined and a first working group was installed to develop a new industry standard for Tamper Verification Features for Medicinal Product Packaging.

New ISO standard

On 30 November 2018, the International Organization for Standardization (ISO) published the new ISO standard 21976:2018 entitled “Packaging – Tamper verification features for medicinal product packaging”. This standard deals with possible types of tamper-evident seals to ensure the integrity of pharmaceutical packaging. As a basis for the ISO 21976:2018 standard, the DIN working group* “Characteristics for checking manipulations on pharmaceutical packaging” proposed the European standard 16679:2014 “Tamper verification features for medicinal product packaging”.

Standard is too generic

But the ISO standard is too generic and does not validate the many different folding carton solutions which are available on the market. That’s where the more specific standard for pharmaceutical cartons should give guidance and provide more detailed technical information about the tamper verification features used for pharmaceutical cartons.

Role Lejeune Association management

Rogier Krabbendam, Association Manager at Lejeune and adviser for ECMA has an initiating and facilitating role for the ECMA Pharma Forum and its members. The development of strategic projects and membership programmes, with both an advisory and executive role, is one of the core competencies of Lejeune.

*DIN, the German Institute for Standardization (Das Deutsche Institut für Normung e.V. (DIN))