The new ISO standard was introduced just last year, and specifies quality requirements for primary packaging in a bid to reduce the risk of product contamination, mix-ups and errors, and promote good manufacturing practice (GMP) in packaging production.
Alcan Packaging Kreuzlingen is part of the Alcan group focussing on flexible packaging, and manufactures products such as blister lidding, pouches, blister packs, barrier films and strip packs.
The Swiss site is the first flexible packaging business in the world to gain ISO 15378 certification, meaning Alcan's customers can be assured that the company adheres to strict GMP standards and rules for the design, manufacture and supply of primary packaging materials for medicinal products to the pharmaceutical industry.
Applying GMP standards to pharmaceutical packaging guarantees that the legal requirements and standards of the pharma industry are met, and will also mean that customers will no longer need to conduct individual audits of packaging suppliers.
Issued by a recognised, international certification body, the accreditation is valid for three years and is compatible with all other ISO standards.
Until the new standard was published last year, there was no applicable guideline for primary packaging materials which contain, seal or are used for dose application and have direct contact with the medicinal product.
The ISO 15378 standard has therefore been increasingly taken up by packaging manufacturers in a bid to give them an edge over their competitors and assure clients of high quality standards.
In February this year, packaging firm Saint-Gobain Desjonquères became the first pharmaceutical glass manufacturer in the world to achieve accreditation for the new standard at all of its production facilities.
Certification at the firm's three French production sites followed the earlier certificate of compliance issued to the company's site in Kipfenberg, Germany, which was the first primary packaging facility in the world to achieve the ISO standard after its introduction in March 2006.
Other packaging firms already accredited include Schott (with Schott Rohrglas in Germany the first tubing manufacturer to gain certification) and MGlas, one of the first companies to achieve accreditation back in July 2006.
The ISO standard itself was developed over a period of several years through collaborations with leading pharmaceutical laboratories, and combines ISO standard 9001:2000 (for quality assurance management systems) with GMP standards for pharmaceutical packaging materials.
ISO 15378 is the first ISO standard to incorporate GMP into its requirements.
The standard also contains guidance annexes on risk management and validation.
Initially conceived for glass products, the standard was expanded to cover all primary packaging materials (glass, plastic, rubber, aluminium etc) with the next step to extend the standard to cover secondary packaging materials as well.
According to Peter Schröder of MGlas, adopting the ISO standard and gaining accreditation can offer serious advantages to packaging firms, and not just in term of customer confidence.
According to Schröder, the reduction in the number of audits alone can save a company around €10,000 over five years, and applying GMP standards in general contributes to around one third of overall growth.