IPAC-RS

OINDP Materials

The OINDP Materials Working Group objectives  are to improve materials quality and integrity, reduce supply chain problems, and promote reduction or elimination of unnecessary testing through: 1) scientific, peer-reviewed publication(s) on the improvements in OINDP quality, and 2) education and training of all parties involved with the supply chain for OINDP components

Our activities involve developing a material change risk assessment tool; collaborating with ELSIE on a paper for ICH Q3D; contact with China National Pharmaceutical Packaging Assoc (CNPPA); translation of the Leachables and Extractables Handbook into Chinese; collaborating with the GRRO China Group on targeted activities related to materials and extractables/leachables in China; and commenting on USP chapters <661>, <1663>, and <1664>.

News

GRRO China and Materials Working Groups - July 2016

The GRRO China and Materials Working Groups are leading the consolidation and submission of IPAC-RS comments on the CNPPA guideline for elastomeric components for drug products (including inhalation products).

OINDP Materials Publicaton

Risk Management for Materials and Components Used in Orally Inhaled and Nasal Drug Products

OINDP Materials Update July 2015

The Materials WG’s paper on “Risk Management for Materials and Components Used in Orally Inhaled and Nasal Drug Products” has been accepted for publication in Pharmaceutical Research. Congratulations to the authors!

OINDP Materials Update June 2015

The Materials Working Group has finished a revised draft of the Baseline Requirements for quality of materials used in drug product container closure systems and will be sharing the draft with a wide range of suppliers and experts within regulatory agencies to obtain feedback and comments.

Materials WG Presentation at SmithersRapra Conference

The Materials Working Group presented on its on-going work to revise its Baseline Requirements document on materials quality, at the 13-14 May SmithersRapra extractables/leachables conference in Bethesda, MD.

OINDP Materials Working Group Paper Published

The IPAC-RS OINDP Materials Working Group, in collaboration with the Extractables and Leachables Safety Information Exchange (ELSIE) Consortium, have published Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review in the PDA Journal of Pharmaceutical Science and Technology, January/February 2015, Vol. 69, No. 11 – 48.

OINDP Materials Working Group

The OINDP Materials Working Group has finished a draft of the materials risk management paper and is seeking to publish it. The Working Group is also currently making revisions to baseline requirements for ensuring quality of materials used in OINDP and will present on this at upcoming the upcoming RAPRA conference on 13 May in Bethesda, MD. The group is also managing the effort to partner with the Pharmaceutical Quality Group to update the PS 9000 GMP guideline for suppliers of packaging components for OINDP.

Past Events

Asia Webconference for Suppliers and OINDP Manufacturers

The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Supplier Quality Working Group hosted a 1.5 hour web-conference for suppliers of container closure system and/or device materials and components for orally inhaled and nasal drug products (OINDP), as well as OINDP manufacturers/developers.

US/Europe Webconference for Suppliers and OINDP Manufacturers

The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Supplier Quality Working Group hosted a 1.5 hour web-conference for suppliers of container closure system and/or device materials and components for orally inhaled and nasal drug products (OINDP), as well as OINDP manufacturers/developers.

Publications

Comments on Guidances

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