Transcription of Extractables and leachables: An Introduction
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Extractables and leachables: An Introduction
Extractables and leachables: An Introduction Tim Hulme Smithers Rapra 44(0)1939 252 418. 1. Smithers Rapra 2015. Extractables and leachables: An Introduction Tim Hulme Smithers Rapra 2. Smithers Rapra 2015. The Smithers Group Plastics, rubber and Environmental sciences polymer materials, supporting product product and process registrations and risk expertise. assessments. Development, analytical Conformity assessments and bioanalytical services of quality and for the pharmaceutical & environmental chemical industries. management systems Materials and product Providing knowledge for knowledge focused on niche, emerging and high- the packaging, paper & growth industries.
2002 FDA – Guidance on Inhalation solution, suspension, spray and nasal spray products 2005 CHMP, CVMP - Guideline for Plastic Immediate Packaging Materials 2006 PQRI – Safety Thresholds & Best Practices For Extractables & Leachables in OINDP 2006 Health Canada/EMA Guidance – Pharmaceutical Quality of Inhalation and Nasal
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