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.

Baseline Requirements Document

The IPAC-RS OINDP Materials Working Group has worked with suppliers to develop baseline requirements for materials used to manufacture components for OINDP. The impetus for this document was based on requests for a uniform set of requirements arising from several discussions between pharmaceutical manufacturers, regulators and multiple suppliers in meetings sponsored by IPAC-RS. As there is no single guidance for these types of materials, these requirements were compiled from a variety of international regulatory and compendial guidelines and standards. A copy of the Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP) is available here: Baseline Requirements.

The IPAC-RS OINDP Materials Working Group is holding the first of a series of webinars addressing aspects of materials quality and discussion of their publicly available Baseline Requirements for Materials used in OINDP. The first webinar session will be held on Thursday, 26 April 2012 (9:00 - 10:30 AM ET) and will provide an introduction to the baseline requirements and recommendations for testing. Subsequent webinars will go into greater detail on specific aspects of various types of extractables testing and management throughout the product lifecycle.

The second and third parts of the webinar series have now been scheduled. An in-depth discussion of Controlled Extraction Study Best Practices will be presented on Thursday, 10 May from 10:00 AM - 11:30 AM ET. This will be followed by Trace Analysis Fundamentals on Tuesday, 22 May from 10:00 - 11:30 AM ET. These webinars will provide key information on concepts and approaches critical to effective extractables and leachables evaluation and materials quality management.

We encourage you to attend these webinars and pass on the information to colleagues who may benefit from the discussions.

For more information, see: OINDP Materials Webinar.

Leachables and Extractables Handbook

The book, Leachables and Extractables Handbook: Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products has now been published. The book addresses safety and best practices related to leachables and extractables, as well as chapters on inorganic leachables and foreign particles. Also included are the protocols from the PQRI L&E work. Authors include IPAC-RS participants, regulators (FDA and Health Canada), and industry experts from outside of IPAC-RS.

The book is available at Wiley. Please share this link and information with your colleagues.

Our members include:

	3M
	AstraZeneca
	Boehringer Ingelheim
	Catalent
	Chiesi
	GlaxoSmithKline
	MannKind Corporation
	MAP Pharmaceuticals
	Merck & Co., Inc.
	Mylan
	Novartis
	Pfizer
	Sunovion
	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:

	Aptar Pharma
	Medspray
	Rexam
	SHL Group
	West