News

Posted On: 10/04/2006

A New Model for Pharma Quality Systems?

PharmaManufacturing.com

By Agnes Shanley, Editor in Chief

Integrated quality systems such as the automotive industry’s QS 9000 still elude pharma, where each supplier must independently audit each vendor to determine quality performance. The existing process can be a wearying and confusing one for both buyer and seller.

ISO 9001 certification establishes some basic quality benchmarks, leveling the playing field for vendors, but it does not address cGMPs or risk assessment. A new ISO standard developed for primary packaging — the plastic, glass, rubber or aluminum used to package parenterals and other products — now incorporates pharma regulatory compliance into ISO 9000 underpinnings.

Based on work that started in Germany, and a five-year genesis that involved input from GMP experts in the U.S. and Europe, and an former top inspector for the U.K.’s regulatory agency, the MHRA, ISO 15378:2006 is now available and in force. “Until now, there was no applicable guideline for primary packaging materials that contain, seal and come into direct contact with the medicinal product,” said Dr. Jurgen Thurk, who convened the working group at ISO that developed the standard.

The standard is expected to eliminate contamination, mixups and errors by establishing a benchmark that can be used for quality improvement, training, auditing and certification. Some of its language can be applied to secondary packaging as well, says Afshin Hosseiny, former quality expert at AstraZeneca who now heads up Tabriz Consulting in the U.K and was actively involved in the committee that established the standard.

It was critical to ensue that the standard use best practices from several sources without any confusing or contradictory language — not only MHRA, but EMEA, and FDA’s requirements had to be met for document control, cleaning, recordkeeping and minimizing the likelihood of cross-contamination.

One benefit for equipment makers and packagers is the fact that it builds on ISO standards. “If you are 9001-certified you already have the infrastructure in place for 15378,” says Hosseiny.

Apparently, this wasn’t the first document to incorporate GMPs into an ISO-type framework. PS9004, a guidance document for parenterals packaging, was one of the first to do this. This month, Hosseiny and his colleague, Tony Harper at Pharmaceutical Technology Consultants, will offer a course on the new ISO standard in Barcelona. To access the PS9004 standard, click here.