46 BioPharm International eBook March 2020 www.biopharminternational.com
Regulatory Sourcebook Pharmacopoeia Compliance Series
REFERENCES
1. J.M. Wiggins and J.A. Albanese,
"Why Pharmacopoeia Compliance Is
Necessary," BioPharm International
Regulatory Sourcebook eBook, 18-25
(September 2019).
2. J.M. Wiggins and J.A. Albanese, "Why
Pharmacopoeia Compliance Is Difficult,"
BioPharm International Regulatory
Sourcebook eBook, 26-34 (September
2019).
3. J.M. Wiggins and J.A. Albanese, "A Brief
History of Pharmacopoeias: A Global
Perspective," www.BioPharmInternational.
com (September 2019).
4. J.M. Wiggins and J.A. Albanese, "Global
Pharmacopoeia Standards: Why
Harmonization is Needed," BioPharm
International Regulatory Sourcebook
eBook, 36-41 (September 2019).
5. J.M. Wiggins and J.A. Albanese,
"Harmonization Efforts by
Pharmacopoeias and Regulatory
Agencies," www.BioPharmInternational.
com (September 2019).
6. J.M. Wiggins and J.A. Albanese,
"Revision Process for Global/National
Pharmacopoeias," BioPharm International
Regulatory Sourcebook eBook, 14-24
(December 2019).
7. J.M. Wiggins and J.A. Albanese,
"Surveillance Process for Industry:
Monitoring Pharmacopoeia Revisions,"
BioPharm International Regulatory
Sourcebook eBook, 26-39 (December
2019).
8. J.M. Wiggins and J.A. Albanese,
"Monograph Development: Why
and When to Participate," BioPharm
International Sourcebook eBook, 12-24
(March 2020).
9. J.M. Wiggins and J.A. Albanese,
"Monograph Development: How to
Participate; How to Harmonize," www.
BioPharmInternational.com (March 2020).
10. J.M. Wiggins and J.A. Albanese, "A
Practical Approach to Pharmacopoeia
Compliance," BioPharm International
Regulatory Sourcebook eBook, 26-35
(March 2020).
11. J.M. Wiggins and J.A. Albanese, "A Case
Study in Pharmacopoeia Compliance:
Excipients and Raw Materials," www.
BioPharmInternational.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 Associations (EFPIA) at the
Workshop "The Chinese and European
Pharmacopoeias—The New Editions,"
Strasbourg, France, Oct. 17, 2016.
13. WHO, Good Pharmacopoeial Practices,
WHO Expert Committee 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 Pharmaceutical Review, 7 (4)
53–57 (Jul–Aug 2004).
15. CDC, "Fatalities Associated with
Ingestion of Diethylene Glycol-
Contaminated Glycerin Used to
Manufacture Acetaminophen 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 Microplastics,"
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 Eribulin Mesilate,"
September 2019, PMDA.go.jp.
21. BP, "Consultation Response: Dissolution
Testing in BP Finished Products
Monographs for Solid Oral Dosage
Forms," pharmacopoeia.com.
22. EDQM, "Dissolution Test in Individual
Monographs on Solid Oral Dosage Forms:
Your Feedback Counts!" EDQM.eu,
European 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
pharmacopoeia monograph drafting
related issues," Surveillance and
translation provided by the R&D-Based
Pharmaceutical Association Committee
(RDPAC) of the China Association of
Enterprises with Foreign Investment
(CAEFI), April 2019.
27. J. Venema, "Ensuring Quality of
Medicines: Role of USP Standards,"
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
Analytics," Int. J. Anal. Chem., Feb. 2,
2015, hindawi.com.
30. J. Pound, "Analytical QbD and the
Pharmacopoeia," Presentation at the 2nd
PDA Europe Pharmacopoeia Conference:
International Developments in the
Pharmacopoeial Landscape, Geneva,
Switzerland, May 16–17, 2019.
31. USP, "Introduction to Continuous
Manufacturing: Pharmaceutical Industry,"
USP Education–Training Details,
USPharmacopeia.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
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 Pharmaceutical 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 Monograph Substances for
Pharmaceutical Use (2034)," Dec. 13,
2019, EDQM.eu
37. EDQM, "The EDQM's Response to
Nitrosamine Contamination," 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 Microbiological
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 Administration on the
Application of the Guiding Principles
of the 11 International 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 Administration on
recommending the application of the four
Guiding Principles of the International
Human Drug Registration Technical
Coordination Committee, including Q8
(R2): Drug Research 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," Presentation at the PDA
Compendial Joint Industry Group Meeting,
Bethesda, MD, USA, July 25, 2019.
47. ICH, "Members & Observers," ICH.org.
BP
