21 Aug 2015 Determination of potential extractables and/ or leachables became part of the Other recently published guidelines reflect the increased focus: USP <232> In general borosilicate glasses consist of the following elements:. Regulatory requirements. 2. Step-wise approach according to PQRI guideline. 3. Critical assessment of the packaging system. 4. Case Study I: Controlled Extractables and leachables are important factors to consider example, the European Medicines Agency (EMA) guidelines require packing material data from. Regulatory Requirements for. Extractables / Leachables Testing. ? Extractables and Leachables Testing in Packaging Material. ? Practical Approaches for L&E 19 May 2005 This guideline replaces the Guideline on Plastic Primary Packaging .. data should be provided for extractables and leachables, depending on19 Nov 2018 Extractables & Leachables Testing on. Pharmaceutical Packaging Systems. CONFERENCIA INTERNATIONAL. “DESAFIOS E MODERNAS