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Development of Baseline Requirements for Materials and a
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Who We Are The IPAC RS Consortium,1989 International Pharmaceutical Aerosol. Consortium IPAC formed to address regulatory,consequences for MDIs of Montreal and Kyoto. 1999 IPAC formed a Working Group to prepare,comments on the FDA draft CMC Guidances for. MDIs DPIs Nasal Sprays and Inhalation,Solutions Suspensions. 2001 International Pharmaceutical Aerosol,Consortium for Regulation and Science IPAC.
RS formed as a separate Consortium, Mission IPAC RS seeks to advance the science of orally inhaled and. nasal drug products OINDP by collecting and analyzing data and. conducting joint research and development projects. IPAC RS Members,3M Merck Co MSD,Actavis Mylan,AstraZeneca Novartis. Boehringer Ingelheim Sunovion,GlaxoSmithKline Supplier Members. Hovione Amcor,Lupin Pharmaceuticals Aptar,MundiPharma Medspray. IPAC RS Workstreams,CMC and Product Development Tests.
Cascade impaction,Emerging mkts,Collaboration,Instructions for Use Population. Human Factors Bioequivalence,Delivery Change Mgmt Modified chi BA BE and. Systems OINDP Materials square ratio test IVIVC,Materials Working Group. To improve packaging and device materials,quality and integrity reduce supply chain. problems and promote rational testing,approaches,The Patient is best served when we provide.
quality packaging and device components,that are both safe and effective throughout. the shelf life of the drug product,Materials Working Group Initiatives. 2004 2005 2006 2008 2010 2012 2014 2016, Formation Publications Presentations to Suppliers Pharma Regulators. of Group e g Webinar Series Presentations to CFDA regulators. Workshops for Pharma Suppliers Regulators,Development of Testing Paradigm. for Supply Chain,Baseline Requirements,Discussed Proposed and Revised.
Risk Management,of OINDP Materials,Material Quality Affects Product Quality. Formulation,Packaging Delivery,System Device, Quality refers to the physical chemical microbiological biological. bioavailability and stability attributes that a drug product should maintain. if it is to be deemed suitable for therapeutic or diagnostic use FDA 1999. Packaging Guidance,Risk Associated with OINDP FDA,Risk Associated with OINDP US Perspective. Risk category, Taken from USP 1664 Assessment of Drug Product Leachables. Associated with Pharmaceutical Packaging Delivery Systems. Material Quality Attributes,Suitable for intended use.
Performance Safety,Functionality Chemical composition. Extractables,Compatibility,Chemical migration,Loss of Potency. Leachables,Degradation,Protection,Precipitation,Temperature. Discoloration,Solvent gases moisture,Brittleness of Package. Risk Associated with OINDP EMA Perspective,Plastic packaging material for drug products.
for oral and topical non ophthalmic inhalation parenteral and ophthalmic administration. Solid dosage form Non solid dosage Solid dosage form Non solid dosage. forms forms, Compliance to appropriate monographs of the European Pharmacopoeia or. the monograph of the pharmacopoeia of a Member State should be demonstrated. if not Compliance with foodstuff legislation if not if not. description description description description description. identification identification identification identification identification. mechanical mechanical characteristic mechanical characteristic. physical or other physical or other properties physical or other properties. characteristic characteristic identification of characteristic identification of. properties properties main additives and properties main additives and. colorants colorants,nature and nature and, Source EMEA Guideline on plastic immediate packaging materials amount of amount of. 19 May 2005 CPMP QWP 4359 03,extractables extractables. Pharma Supply Chain is Complex,SUPPLY CHAIN,N 3 N 2 N 1 N. INGREDIENT MATERIAL CONVERTER,SUPPLIER SUPPLIER ASSEMBLER PHARMA.
MONOMERS POLYMER MOULDER,ANTI STATICS METAL DEVICE MFR. ADDITIVES ELASTOMER VALVE MFR,Controls Needed Throughout Supply Chain. N 3 N 2 N 1 Control,Throughout,the Supply,Extractable. Sources Additives Ambient Contaminants Processing Aids le. Key Documents circa 2005, 1993 CDRH Reviewer Guidance for Nebulizers Metered Dose. Inhalers Spacers and Actuators,1998 FDA MDI DPI Draft Guidance.
1999 FDA Guidance for Industry Container Closure Systems for. Packaging Human Drugs and Biologics, 2002 FDA Guidance on Inhalation solution suspension spray and. nasal spray products,2002 EU Directive 72 Food Contact. 2005 CHMP CVMP Guideline for Plastic Immediate Packaging. 21CFR 170 189,EP 3 USP 381 660 661 Physicochemical. ISO10993 USP 87 USP 88 Biocompatibility,Testing Paradigm circa 2005. Material No Extractables Testing No Sharing of Information. Supplier Performed with Converter Assembler,No sharing of results with.
Converter Material Supplier,Routine Extractables Testing. Assembler No sharing of composition,information with Pharma. Difficult to Achieve,Controlled Extraction Studies. Pharmaceutical Correlation between,Leachables Studies. Manufacturer Extractables and Leachables,Routine Extractables Testing.
Inadequate Understanding of Material,Testing Redundancy. Production Delays,Key Documents 2006 2011,2006 PQRI Safety Thresholds Best Practices For. Extractables Leachables in OINDP,2006 Health Canada EMA Guideline on the. Pharmaceutical Quality of Inhalation and Nasal Products. 2007 European Parliament Council Medical Device,Directive 93 42 EEC as amended. 21CFR 170 189 COMMISSION REGULATION EU No,10 2011 Food contact.
Development of Baseline Requirements for Materials and a Rationalized Testing Paradigm Cheryl LM Stults PhD 09 Sep 2016 Authored by the IPAC RS OINDP Materials Working Group 1989 International Pharmaceutical Aerosol Consortium IPAC formed to address regulatory consequences for MDIs of Montreal and Kyoto Protocols 1999 IPAC formed a Working Group to prepare comments on the FDA draft CMC

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