Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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42 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m 9. J.M. Wiggins and J.A. Albanese, "Monograph Development: How to Participate; How to Harmonize," www.PharmTech.com (March 2020). 10. J.M. Wiggins and J.A. Albanese, "A Practical Approach to Phar- macopoeia Compliance," Pharmaceutical Technology Regulatory Sourcebook eBook, 24-32 (March 2020). 11. J.M. Wiggins and J.A. Albanese, "A Case Study in Pharmaco- poeia Compliance: Excipients and Raw Materials," www.Pharm- Tech.com (March 2020). 12. J.M. Wiggins, "Importance of Pharmacopoeia Standards: Their Added Value for Stakeholders," Remarks provided on behalf of the European Federation of Pharmaceutical Industries and As- sociations (EFPIA) at the Workshop "The Chinese and Euro- pean Pharmacopoeias—The New Editions," Strasbourg, France, Oct. 17, 2016. 13. WHO, Good Pharmacopoeial Practices, WHO Expert Commit- tee on Specifications for Pharmaceutical Preparations Fiftieth Report, Technical Report Series No. 996, Annex 1, pp. 67–85 (2016). 14. N.A. Schwarzwalder and R.H. Bishara, American Pharmaceuti- cal Review, 7 (4) 53–57 (July–August 2004). 15. CDC, "Fatalities Associated with Ingestion of Diethylene Gly- col-Contaminated Glycerin Used to Manufacture Acetamino- phen Syrup–Haiti, November 1995–June 1996," cdc.gov. 16. H. Liu, Z. Zhang, and R.J. Linhardt, Natural Product Reports, 26 (3) 313–321 (March 2009). 17. EMA, "Sartan Medicines: Companies to Review Manufacturing Processes to Avoid Presence of Nitrosamine Impurities," ema. europa.eu, Press Release, Feb. 1, 2019. 18. ECHA, "ECHA Proposes to Restrict Intentionally Added Micro- plastics," echa.europa.eu, News Release, ECHA/PR/19/03, Jan. 30, 2019. 19. USP, "USP Guideline for Submitting Requests for Revision to USP–NF, Submission Guideline for Chemical Medicines," USP. org, April 29, 2016. 20. PMDA, "Briefing on Proposed Draft Official Monograph Eribu- lin Mesilate," September 2019, PMDA.go.jp. 21. BP, "Consultation Response: Dissolution Testing in BP Finished Products Monographs for Solid Oral Dosage Forms," pharmaco- poeia.com. 22. EDQM, "Dissolution Test in Individual Monographs on Solid Oral Dosage Forms: Your Feedback Counts!" EDQM.eu, Euro- pean Pharmacopoeia Public Enquiry, Jan. 17, 2019. 23. S. Keitel, "The Pharmacopeia in the 21st Century," PDA.org, PDA Letter, April 2019. 24. S. Kozlowski, "Ensuring That Standardization Does Not Impede Biological Product Innovation," FDA.gov, CDER Conversations, June 12, 2019. 25. Congress, "A Bill to Lower Health Care Costs," 116th Congress, 1st session, S. 1895, Section 207, Biological Product Innovation, July 8, 2019, Congress.gov. 26. "Questionnaire on materials collection for the development of monoclonal antibody national standard and mAb pharmaco- poeia monograph drafting related issues," Surveillance and translation provided by the R&D-Based Pharmaceutical Associ- ation Committee (RDPAC) of the China Association of Enter- prises with Foreign Investment (CAEFI), April 2019. 27. J. Venema, "Ensuring Quality of Medicines: Role of USP Stan- dards," Presentation at the 2nd PDA Europe Pharmacopoeia Conference: International Developments in the Pharmacopoeial Landscape, Geneva, Switzerland, May 16–17, 2019. 28. MHRA, "Consultation Response: Strategy for Pharmacopoeial Public Quality Standards for Biological Medicines," Updated September 16, 2019, gov.uk. 29. R. Peraman, K. Bhadraya, and Y.P. Reddy, "Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analyt- ics," Int. J. Anal. Chem., Feb. 2, 2015, hindawi.com. 30. J. Pound, "Analytical QbD and the Pharmacopoeia," Presenta- tion at the 2nd PDA Europe Pharmacopoeia Conference: Inter- national Developments in the Pharmacopoeial Landscape, Ge- neva, Switzerland, May 16–17, 2019. 31. USP, "Introduction to Continuous Manufacturing: Pharmaceu- tical Industry," USP Education–Training Details, USPharmaco- peia.csod.com. 32. EDQM, General Chapter: 5.28 Multivariate Statistical Process Control (MSPC), Ph. Eur., Pharmeuropa, 31.3 (July 2019). 33. EDQM, "Ph. Eur. Commission Consults Stakeholders on the General Chapter on Multivariate Statistical Process Control (MSPC) (5.28)," July 4, 2019, EDQM.eu, www.edqm.eu/en/news/ ph-eur-commission-consults-stakeholders-general-chap- ter-multivariate-statistical-process 34. ECA Academy, "New Ph. Eur. Chapter on Statistical Process Control (SPC) Planned," gmp-compliance.org, GMP News, Sep. 18, 2019. 35. EDQM, General Monograph 2034 Substances for Pharmaceuti- cal Use, Ph. Eur., Pharmeuropa, 32.1 (January 2020). 36. EDQM, "Detection of N-nitrosamine Impurities: The Ph. Eur. Launches a Public Consultation on the Revised General Mono- graph Substances for Pharmaceutical Use (2034)," Dec. 13, 2019, EDQM.eu 37. EDQM, "The EDQM's Response to Nitrosamine Contamina- tion," EDQM.eu. 38. USP, General Chapter <661> Plastic Packaging Systems and Their Materials of Construction, Pharmacopeial Forum, 45(2) (March–April 2019). 39. ICH, Quality Guidelines, ICH.org. 40. M.J. Miller, "The Regulatory Acceptance of Rapid Microbiologi- cal Methods," European Pharmaceutical Review, June 29, 2017, europeanpharmaceuticalreview.com. 41. FDA News, "China Joins ICH as Full Regulatory Member, Pledges to Implement Guidelines," June 22, 2017, fdanews.com. 42. NMPA, "Announcement of the State Food and Drug Adminis- tration on the Application of the Guiding Principles of the 11 In- ternational Coordinating Committee for the Registration of Human Drugs, including Q2 (R1): Demonstration of Analytical Methods: Text and Methodology (No. 7 of 2020)," Jan. 10, 2020, NMPA.gov.cn. 43. NMPA, "Announcement of the State Food and Drug Administra- tion on Recommending the Application of the Four Guiding Principles of the International Human Drug Registration Tech- nical Coordination Committee, including Q8 (R2): Drug Re- search and Development (No. 6 of 2020)," Jan. 10, 2020, NMPA. gov.cn. 44. Chinese Pharmacopoeia Commission, "Compendium of the Chinese Pharmacopoeia 2020 Edition," Jan. 30, 2018, ChP.org.cn. 45. K. Huynh-Ba and A.B. Sassi, "ANVISA: An Introduction to a New Regulatory Agency with Many Challenges," AAPS Open, Vol. 4, Article 9 (Dec. 12, 2018). 46. A. L. Lopes da Silva, "The Brazilian Pharmacopoeia," Presenta- tion at the PDA Compendial Joint Industry Group Meeting, Bethesda, MD, USA, July 25, 2019. 47. ICH, "Members & Observers," ICH.org. PT Pharmacopoeia Compliance Series

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