Container–Content Compatibility Studies: A Pharmaceutical Team's Integrated Approach

References

1. 1.↵
   European Medicines Agency. CPMP/QWP/4359/03, EMEA/CVMP/205/04: Guideline on Plastic Immediate Packaging Materials. European Medicines Agency: London, UK, 19 May 2005
2. 2.↵
   European Pharmacopoeia, 6th ed.; 2008, 6.1: 3.1.3 Polyolefins; 3.1.4. & 3.1.5 Polyethylene without and with additives for containers for parenteral preparations and for ophthalmic preparations; 3.1.6 Polypropylene for containers and closures for parenteral and ophthalmic preparations; 3.1.7 Polyethylene-vinyl acetate for containers and tubing for parenteral nutrition preparations; 3.2.1 Glass containers for pharmaceutical use; 3.2.2 to 3.2.8 Plastic containers … ; 3.2.9 Rubber closures for containers for aqueous parenteral preparations for powder and for freeze-dried products
3. 3.↵
   Food and Drug Administration. Guidance for Industry—Container–Closure Systems for Packaging Human Drugs and Biologics, 1999.
4. 4.↵
   Food and Drug Administration. Guidance for Industry—Nasal Spray and Inhalation Solution, Suspension and Drug Products Points To Consider, 2002.
5. 5.↵
   Code of Federal Regulations. 21 CFR 211.94(a) through Subpart E: Control of Components and Drug Product Containers and Closures.
6. 6.↵
   Code of Federal Regulations. 21 CFR 310.509: Requirements for specific new drugs or devices—parenteral drug products in plastic containers.
7. 7.↵
   Code of Federal Regulations. 21 CFR 600.11: Biological products—(b) Equipment through (h) Containers & closures.
8. 8.↵
   United States Pharmacopoeia 30, 2007: 〈1031〉 Biocompatibility of materials used in drug containers, medical devices and implants, pp 402–410: 〈87〉 Biological reactivity tests, in vitro, pp 113–115; 〈88〉 Biological reactivity tests, in vivo, pp 115–118; (661) Containers, pp 260–267; (381) Elastomeric closure for injections, pp 157–158; 〈671〉 Containers permeation, pp 267–269
9. 9.↵
   Japanese Pharmacopoeia XV, 2006: 〈11〉 Plastic container for pharmaceutical products; 〈59〉 Tests for rubber closures for aqueous infusions; 〈61〉 Tests methods for plastic containers, 7 cytotoxicity tests
10. 10.↵
    ISO Standard 10993 Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing
11. 11.↵
    PQRI. Reporting and Qualification Thresholds for Leachables in Parenteral and Ophthalmic Drug Products, March 2007
12. 12.↵
    PQRI. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, September 2006.
13. 13.↵
    American Society for Testing and Materials F813-01. Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices.
14. 14.↵
    American Society for Testing and Materials F895. Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity.
15. 15.↵
    International Conference on Harmonization. ICH Q2 (R1): Validation of Analytical Procedures: Text and Methodology, 2005.
16. 16.↵
    International Conference on Harmonization. ICH Q3B (R2): Impurities in New Drug Products, 2006.
17. 17.↵
    International Conference on Harmonization. ICH Q1A (R2): Stability Testing Guidelines: Stability Testing of New Drug Substances and Products (CPMP/ICH/380/95—2^nd revision 2003).
18. 18.↵
    International Conference on Harmonization. ICH Q5C: Stability Testing of Biotechnological/Biological Products (CPMP/ICH/138/95—revision 1999).