Recommended

New webinar with Fujifilm: Monocyte activation test (MAT): Insight into examining regulations and markets prospects
New webinar: The path to optimisation in pharmaceutical microbiology
Join our webinar: An alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
Discover more in our new application note: validating recombinant cascade reagents in 3 simple steps
reference

Jenke D. Strategic aspects of change control. European Pharmaceutical Review. 2017;22(2):60-62

Posted: 12 July 2017 | | No comments yet

References Arbin A, Jacobsson S, Hanninen K, Hagman A, Ostelius J. Studies on the contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques. Int J Pharm. 1986;28(2-3):211-218. Goydan R, Schwope AD, Redi RC, Cramer G. High-temperature migration of anti-oxidants from polyolefins. Food Additives and Contaminants. 1990;7(3):323-337. Kim-Kang H, Gilbert SG. […]

References

  1. Arbin A, Jacobsson S, Hanninen K, Hagman A, Ostelius J. Studies on the contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques. Int J Pharm. 1986;28(2-3):211-218.
  2. Goydan R, Schwope AD, Redi RC, Cramer G. High-temperature migration of anti-oxidants from polyolefins. Food Additives and Contaminants. 1990;7(3):323-337.
  3. Kim-Kang H, Gilbert SG. Isolation and identification of potential migrants in gamma-irradiated and non-irradiated plastic laminates for unit dose injection device. Appl Spectrosc. 1991;45(4):572-580.
  4. Sarbach C, Yagoubi N, Sauzieres J, Renaux C, Ferrier D, Postaire E. Migration of impurities from a multi-layer plastic container into a parenteral infusion solution. Int J Pharm. 1996;140:169-174.
  5. Kim H, Gilbert SG, Johnson JB. Determination of potential migrants from commercial amber polyethylene terephthalate bottle wall. Pharm Res. 1990;7(2):176-179.
  6. Danielson DM, Oxborrow GS, Placencia AM. Chemical leaching of rubber stoppers into parenteral solutions. J Parent Sci Technol. 1983;37(3):89-92.
  7. Reif AW, Solkner P, Rupp J. Analysis and evaluation of filter cartridge extractables for validation in pharmaceutical downstream processing. PDA J Pharm Sci Technol. 1996;50(6):399-410
  8. Jenke D R. Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA J Pharm Sci Technol. 2002;56(6):332-371.
  9. Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration; Rockville, MD. May1999.
  10. Guideline on Plastic Immediate Packaging Materials. European Medicines Agency. CPMP/QWWP/4359/03. EMEA/CVMP/205/04. 5/19/05.
  11. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI Leachables and Extractables Working Group. September 9, 2006. Available at http://www.pqri.org/pdfs/LE-Recommendations-to-FDA-09-29-06.pdf.
  12. Guidance for Industry. M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. U.S. Department of Health and Human Services, Food and Drug Administration; Rockville, MD. May 2015.
  13. 〈661.1〉 PLASTIC MATERIALS OF CONSTRUCTION. USP39-NF34, page 493. Official May 1, 2016.
  14. 3.1.6. Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations. European Pharmacopoeia 8.0. Council of Europe, Strasbourg, 2014, pp. 388.