SUPPLIER QUALITY EVALUATION QUESTIONNAIRE
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 |
| | | |
|Packaging Information |
|1.1 |Please provide a description of the material: |
| | |
|1.2 |Please provide an infra-red spectrum of the packaging material described above |Ref: |
|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 / materials 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 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 indicate 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 (particulate & microbial) |
| |d) It is 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 |
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