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1、Supplier Quality Questionnaire 4559361090.doc Page 1 of 2 F.Packaging Material In case the questionnaire covers more than one product,please use a separate form F for each product.Material Brand Name Material Type Product Code 1.Packaging Information 1.1 Please provide a description of the material:
2、1.2 Please provide an infra-red spectrum of the packaging material described above Ref:Supplier Quality Questionnaire 4559361090.doc Page 2 of 2 1.3 Please confirm by signature that the packaging material described above fulfills all of the following criteria:a)No BSE/TSE risk-related ingredients/ma
3、terials have been used in the manufacture b)It is suitable for use in contact with foodstuffs and it is in full compliance with Council Directive 1935/2004 relating to materials and articles intended to come into contact with foodstuffs,including its current amendments it is in full compliance with
4、Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs,including its current amendments it is in full compliance with the relevant regulations of the BAG it is in full compliance with the following relevant FDA regulations(please indi
5、cate applicable CFR references):it is in full compliance with Council Directive 1935/2004 relating to materials and articles intended to come into contact with foodstuffs,including its current amendments c)There are measures in place to avoid contamination of the product(particulateµbial)d)It i
6、s in full compliance with the requirements of the following monographs of the current edition of the European Pharmacopoeia indicated in chapter 3.1.Materials used for the manufacture of containers Monograph number 30202:3.2.2.Plastic containers and closures for pharmaceutical use Monograph number 30103:3.1.3.Polyolefines Monograph number 30111:3.1.11.Materials based on non-plasticized poly(vinyl chloride)for containers for dry dosage forms for oral administration Monograph number 30113:3.1.13.Plastic additives Date,Location Print Name Signature Position