Regulatory Compliance
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PVC Pharmaceutical Films
All KP Tech PVC films are DMF registered and manufactured in a clean-environment, in accordance with cGMP.
REGULATORY APPROVALS
- REACH updated January 2019
- 94/62 EC
- TSE and BSE Free
- 10/2011 EC
- 1935/2004 EC
- California Prop 65
- USP 661
- 21 CFR 178: 2010
- 21 CFR 178: 2550
- 21 CFR 178: 2650
- 21 CFR 175: 300
- US CONEG
- Ph. Copeia 3.1.11
APET Films
- USFDA CFR 21 : 177.1630
- BRC British Retail Consortium
- CONEG limits on heavy metal
- ISO 9001/14001
- SGS REACH
- SGS EU 94/62
- EU 10.2011. Migration