密封件慎用的添加剂种类及参考资料

8. 附件

密封件慎用的添加剂种类

9. 参考资料

1）化学药品注射剂与塑料包装材料相容性研究技术辅导准则（试行）（国食药监注〔2012〕267号）

2）化学药品注射剂与药用玻璃包装容器相容性研究技术辅导准则（试行）（国家食品药品监督管理总局布告2015年第40号）

3）《中国人民共和国药典》2015年版 公例9621、9622

4）YBB00142002-2015药品包装材料与药物相容性实验辅导准则

5）ICH M7 （R1） Assessment and Control of DNA Reactive （Mutagenic） Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.

6）ICH Q3D Guideline for Elemental Impurities.

7）EMEA Guideline on Plastic Immediate Packaging Materials. （2005）

8）European Pharmacopoeia （Ph.Eur） Chapter 3 “Materials and Containers”.

9）United States Pharmacopeia （USP） Chapter 87, 88, 381, 1381, 1663, 1664.

10）Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, PQRI Leachables and Extractables Working Group. （2006）

11）Comprehensive Determination of Extractables from Five Different Brands of Stoppers Used for Injectable Products. PDA Journal of Pharmaceutical Science and Technology 2009, 63 527-536.

12）Experimental Protocol for Qualitative Controlled Extraction Studies on Material Test Articles Representative of Prefilled Syringe （PFS） and Small Volume Parenteral （SVP） Container Closure Systems. PQRI Parenteral and Ophthalmic Drug Products Leachables and Extractables Working Group.（2011）

13）Perspectives on the PQRI Extractables and Leachables ''Safety Thresholds and Best Practices'' Recommendations for Inhalation Drug Products. PDA Journal of Pharmaceutical Science and Technology 2013, 67 413-429.

14）The Product Quality Research Institute （PQRI） Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product （PODP） . PDA Journal of Pharmaceutical Science and Technology 2013, 67 430-447.

15）Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products. PDA Journal of Pharmaceutical Science and Technology 2013, 67 448-511.

16）Simulated Leaching （Migration） Study for a Model Container-closure System Applicable to Parenteral and Ophthalmic Drug Products （PODPs）. PDA Journal of Pharmaceutical Science and Technology 2016, 70 1-46.

17）Jenke, D. Compatibility of Pharmaceutical Products and Contact Materials. Safety Considerations Associated with Extractables and Leachables. Hoboken, NJ. John Wiley & Sons. 2009.

18）Ball, Douglas J., Norwood, Daniel L., Stults, Cheryl L.M., Nagao, Lee M., ed.

Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products. Hoboken, NJ. John Wiley & Sons. 2012.