All Roads Now Lead to Quality Systems

After five years in the making, the official pharmaceutical quality system is here. All three parties to ICH adopted a final version of Q10 and agreed to implement the guideline through their indivdidual regulatory bodies.
Aug 02, 2008
Volume 32, Issue 8

Fully known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH finalized the concept of Q10 Pharmaceutical Quality System in late 2005 with the aim of facilitating innovation and continual improvement, and strengthening the link between pharmaceutical development and manufacturing activities, according to the guideline's business plan. Incorporating the concepts behind ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management, Q10 provides a model for "a pharmaceutical quality system that can be implemented throughout the different stages of a product life cycle" (1–3). Q10 rounds out the ICH "trio" and paves the way through harmonized understanding of quality systems for industry and regulators to reap the benefits of process understanding and risk management fostering industry management of change, continual improvement, and better, more efficient regulatory oversight.

The final version, to be published in the Federal Register this summer and now available on the ICH website, contains new and expanded language compared to its May 2007, Step 2, draft. The changes include new and expanded sections about outsourced activities, purchased ingredients, change management, and knowledge management, based on feedback received during Step 3 of the harmonization process (the consultation and comment period), which took place May 2007–June 2008.

ICH Q10 is meant to complement and enhance existing regional current good manufacturing practices (CGMPs), but as a guideline, it is not enforceable. However, as industry leaders move farther into the use of quality-by-design (QbD), manufacturers large and small across the globe will find that the components and tools recommended within Q10—and its sister ICH quality guidelines—are going to be considered standard best practices by all ICH-region regulators, including the US Food and Drug Administration, European Commission, European Medicines Agency, and Japanese Ministry of Health, Labor, and Welfare.

Pharmaceutical Technology and SGS, an inspection, verification, testing, and certification company, held a webcast titled "Quality Systems in the Global Marketplace" on June 12, focused on Q10's adoption. Participating panelists included Joseph C. Famulare, deputy director of the Center for Drug Evaluation and Research at FDA (Famulare also led the Expert Working Group (EWG) that moved Q10 through to Step 4 of harmonization); Gerald Migliaccio, vice-president of Global Quality and Environmental Health and Safety Operations at Pfizer (Migliaccio also served as the ICH Q10 rapporteur, leading Q10 through Step 2 of harmonization); Karen Ginsbury, president of PCI Pharmaceutical Consulting Israel; Zena G. Kaufman, divisional vice-president for Abbott Quality & Regulatory, and a member of the ICH Q10 Expert Working Group for the Pharmaceutical Research and Manufacturers of America; Nicholas Cappuccino, PhD, chief scientific officer for Eagle Pharmaceuticals and member of the ICH Quality Implementation Working Group (IWG) representing the International Generic Pharmaceutical Alliance; and Jacques Morenas, PIC/S chairman and European Commission representative to the ICH Quality Working Group. The event was moderated by consultant and editorial advisory board member Susan J. Schniepp (4).

This article, based on excerpts from the webcast, provides insight into the expectations and challenges that come with ICH Q10 implementation.

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