IPAC-RS International Pharmaceutical Aerosol Consortium on Regulation and Science

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Click here to view presentations from the IPAC-RS 2008 Conference

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Welcome to IPAC-RS. We are an international association of innovator and generic companies that develop, manufacture or market orally inhaled and nasal drug products for local and systemic treatment of a variety of debilitating diseases such as asthma, chronic obstructive pulmonary disease and diabetes.

We are committed to advancing consensus-based, scientifically driven standards and regulations for these products, with the purpose of facilitating the availability of high-quality, safe, and efficacious drug products to patients.

IPAC-RS Materials Forum

The IPAC-RS OINDP Materials Working Group hosted a Workshop in Barcelona, Spain on Tuesday, 12 May 2009 . Presentations from the Forum are available: Here .

The Working Group will hold another Workshop in Philadelphia, PA on 13-14 September 2009. REGISTRATION is now open. For information, click: Here .

IPAC-RS Supplier Quality Control Quality Agreement Template

The IPAC-RS Supplier Quality Working Group has developed this Quality Agreement Template as a toolkit for suppliers and OINDP manufacturers. The template provides guidance on elements of a quality agreement between OINDP manufacturers and their component/ packaging suppliers (N-1 suppliers), and N-1 suppliers and their suppliers. The template links specific elements of the quality agreement with GMP recommendations made in the Working Group's GMP Guideline for Suppliers of Components for OINDP.

IPAC-RS 2008 Conference

Presentations from the 2008 IPAC-RS Conference “Doing the Right Thing” in the Changing Culture of Design and Development of Inhalation and Nasal Drug Products: Science, Quality, and Patient-Focus are available here: Presentations.

Posters are available here: Posters

Points to Consider for a P2 for an Orally Inhaled or Nasal Drug Product

The Points to Consider was developed by the IPAC-RS Model OINDP Working Group to provide industry perspectives and best thinking on the reporting of development data in the P2 (Pharmaceutical Development) section of the Common Technical Document. The document follows the guidance provided in ICH Q8 but provides further insight on issues of significance for OINDP such as container closure systems/device and particle size.

The Points to Consider is a "living document," and IPAC-RS welcomes comments on the paper and feedback from its pplication.

Our members include:

	3M
	Abbott
	AstraZeneca
	Boehringer Ingelheim
	Chiesi
	GlaxoSmithKline
	MannKind Corporation
	Novartis
	Pfizer
	sanofi-aventis
	Schering-Plough
	Teva
	Vectura Ltd.

In addition, the following suppliers of device components for orally inhaled and nasal drug products participate in the Supplier Quality Control Initiative of IPAC-RS:

	Bespak
	Rexam
	SHL Group
	Valois
	West

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