reference

Miller M. The regulatory acceptance of rapid microbiological methods. European Pharmaceutical Review. 2017;3:55-58

Posted: 12 July 2017 | | No comments yet

References European Medicines Agency. Inspectors Working Group. Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. EMA/INS/GMP/489331/2016 GMP/GDP. 2016. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211657.pdf Alternative Methods for Control of Microbiological Quality, European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa. 2017; Chapter 5.1.6. Supplement 9.2 Parenteral Drug […]

References

  1. European Medicines Agency. Inspectors Working Group. Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. EMA/INS/GMP/489331/2016 GMP/GDP. 2016. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211657.pdf
  2. Alternative Methods for Control of Microbiological Quality, European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa. 2017; Chapter 5.1.6. Supplement 9.2
  3. Parenteral Drug Association. Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods, Technical Report No. 33. Revised 2013.
  4. European Medicines Agency. Human Medicines Research and Development Support. Guidance for applicants seeking scientific advice and protocol assistance. EMA/691788/2010 Rev. 7. 2014. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004089.pdf
  5. European Medicines Agency. Questions and Answers on Post Approval Change Management Protocols. Committee for Medicinal Products for Human Use (CHMP). EMA/CHMP/CVMP/QWP/586330/2010. 2012. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/04/WC500125400.pdf
  6. Food and Drug Administration. Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information. Guidance for Industry. U.S. Department of Health and Human Services, Rockville, Maryland. 2016. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496611.pdf
  7. Guidance for Industry CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports. U.S. Department of Health and Human Services, Rockville, Maryland. 2014. www.fda.gov/downloads/Drugs/…/Guidances/UCM217043.pdf
  8. European Commission. Volume 2B. Notice to Applicants Medicinal products for human use. Presentation and format of the dossier. 2006. http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf
  9. Mycoplasmas, European Directorate for the Quality of Medicines & HealthCare. 9.1 Pharmeuropa. 2017. Chapter 2.6.7
  10. European Medicines Agency. Mutual recognition agreements. www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000248.jsp&mid=WC0b01ac058005f8ac
  11. European Commission. Regulation No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. 2008. http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2008_1234_cons_2012-11-02/reg_2008_1234_cons_2012-11-02_en.pdf
  12. Validation of Alternative Microbiological Methods. United States Pharmacopeial Convention. US Pharmacopeia. <1223>. 2016. USP 39/NF34: 1616.
  13. Miller, MJ. Rapid methods update: revisions to a United States Pharmacopeia chapter. European Pharmaceutical Review. 2015;20(4):38-43.
  14. The Japanese Pharmacopoeia, Seventeenth Edition (JP17). http://jpdb.nihs.go.jp/jp17e/
  15. World Health Organization. Annex 6 GMPs for Sterile Pharmaceutical Products. WHO Technical Report Series, No. 961. 2011. www.who.int/medicines/areas/quality_safety/quality_assurance/GMPSterilePharmaceuticalProductsTRS961Annex6.pdf
  16. European Medicines Agency. Quality of medicines Q&A: Part 2. Water – Microbiological Control of Water. Joint CHMP/CVMP Quality Working Party. 2005. www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000072.jsp&mid=WC0b01ac058002c2b0&murl=menus/regulations/regulations.jsp&jsenabled=true#section11
  17. Gressett G. IQ, OQ and PQ Validation Project Overview – A Case Study. In Rapid Sterility Testing. Moldenhauer J (ed.). PDA-DHI Publishing. 2011.
  18. Hussong D, Mello R. Alternative Microbiology Methods and Pharmaceutical Quality Control. American Pharmaceutical Review. 2006;9(1):62-69. www.americanpharmaceuticalreview.com/Featured-Articles/113093-Alternative-Microbiology-Methods-and-Pharmaceutical-Quality-Control/