Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm

详细信息    查看全文

• 作者：Glenn A. Van Buskirk (1)
  Satish Asotra (2)
  Christopher Balducci (3)
  Prabir Basu (4)
  Gerald DiDonato (5)
  Angelica Dorantes (6)
  W. Mark Eickhoff (7)
  Tapash Ghosh (6)
  Mario A. González (8)
  Theresa Henry (9)
  Matthew Howard (10)
  Jason Kamm (11)
  Steven Laurenz (12)
  Ryan MacKenzie (13)
  Richard Mannion (14)
  Patrick K. Noonan (15)
  Terrance Ocheltree (6)
  Umesh Pai (16)
  Richard P. Poska (12)
  Michael L. Putnam (17)
  Ramani R. Raghavan (18)
  Colleen Ruegger (3)
  Eric Sánchez (19)
  Vinod P. Shah (20)
  Zezhi Jesse Shao (21)
  Russell Somma (22)
  Vijay Tammara (23)
  Avinash G. Thombre (24)
  Bruce Thompson (7)
  Robert J. Timko (25)
  Satyam Upadrashta (26)
  Sivakumar Vaithiyalingam (27)
  
• 关键词：CMC ; ICH ; IVIVC ; PAT ; QbD
• 刊名：AAPS PharmSciTech
• 出版年：2014
• 出版时间：June 2014
• 年：2014
• 卷：15
• 期：3
• 页码：665-693
• 全文大小：
• 参考文献：1. Skelly JP, Van Buskirk GA, Savello DR, Amidon GL, Arbit HM, Dighe S, / et al. Scaleup of immediate release oral solid dosage forms. Pharm Res. 1993;10:313-. k" title="It opens in new window">CrossRef
  2. Skelly JP, Van Buskirk GA, Arbit HM, Amidon GL, Augsburger L, Barr WH, / et al. Scaleup of oral extended-release dosage forms. Pharm Res. 1993;10(12):1800-. k" title="It opens in new window">CrossRef
  3. Communication from the Commission—Guideline on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. Off J Eur Union, 22.1.2010, C17/1-41. http://ec.europa.eu/health/files/eudralex/vol-2/c17_1/c17_1_en.pdf.
  4. Post-Notice of Compliance (NOC) Changes—quality guidance appendix 1 for human pharmaceuticals. Canada Ministry of Health, Health Products and Food Branch, Implementation 10/17/2011. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.pdf.
  5. FDA challenges and opportunities report—innovation or stagnation: challenge and opportunity on the critical path to new medical products. US Department of Health and Human Services, Food and Drug Administration, March 2004. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm.
  6. International Conference on Harmonization Guideline ICH Q6A: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. October 1999. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm134966.htm.
  7. Lionberger RA, Lee SAU, Lee L, Rau A, Yu LX. Quality by design: concepts for ANDAs. AAPS J. 2008;10(2):268-8. doi:10.1208/s12248-008-9026-7 . k" title="It opens in new window">CrossRef
  8. FDA manual of policies and procedures. Center for Drug Evaluation and Research, Office of Pharmaceutical Science, MAPP 5016.1—Applying ICH Q8(R2), Q9, and Q10 principle to CMC review. February 2011. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM242665.pdf.
  9. International Conference on Harmonization Guideline ICH Q8(2)—Pharmaceutical development. November 2008. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073507.pdf.
  10. International Conference on Harmonization Guideline ICH Q9—quality risk management. November 2005. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073511.pdf.
  11. International Conference on Harmonization Guideline ICH Q10—Pharmaceutical quality systems. June 2008. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073517.pdf.
  12. International Conference on Harmonization Guideline ICH Q11—Development and manufacture of drug substances (Chemical entities and biotechnological/biological entities). May 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf.
  13. Guidance for Industry: PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. September 2004. http://www.fda.gov/downloads/Drugs/-Guidances/ucm070305.pdf.
  14. United States Code of Federal Regulations, Title 21—Food and drugs. Chapter 1—Food and Drug Administration Department of Health and Human Services, Subchapter D—Drugs for human use, Part 314—Applications for FDA approval to market a new drug, Subpart B—Applications, Section 314.70—Supplements and other changes to an approved application.
  15. Guidance for Industry: Changes to an approved NDA or ANDA, Revision 1. April 2004. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM077097.pdf.
  16. Draft Guidance for Industry: CMC post-approval manufacturing changes reportable in annual reports. June 2010. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf
  17. Health Canada Draft Quality (Chemistry and Manufacturing) Guidance: New drug submissions (NDSs) http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/qual_ndsands_pdnpadn_07-01-eng.pdf.
  18. Abbreviated New Drug Submissions (SNDSs) rather than the PMNOC-QD, or stability data requirements as per Health Canada Guidance Stability Testing of Existing Drug Substances and Product http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/stabt_stabe-eng.pdf.
  19. Post Authorization Procedural Advice on Variation Regulation (EC) No. 1234/2008. EMA/40404/2010 http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500060512.pdf.
  20. Public Consultation Paper—Review of the variations guidelines regulation (EC) No. 1234/2008 Article 4: Review of the variations guidelines European Commission, Health and Consumers Directorate—General Health Systems and Products Medicinal products—Authorizations, EMA, Brussels, Sanco.ddg1.d.5(2012)817838. http://ec.europa.eu/health/files/betterreg/2012_06_11_public_consultation_en.pdf.
  21. Guideline for descriptions on application forms for marketing approval of drugs, etc. under the revised pharmaceutical affairs law, PFSB/ELD notification no. 0210001, February 10, 2005. http://www.pmda.go.jp/english/service/pdf/guideline_application-2.pdf.
  22. Balducci C, LoBrutto R, Royce A, Cheney J, Xiang D, Darmuzey O, Valthorsson H. Quality by design and compression. In: Celik M, editor. Pharmaceutical powder compaction technology-^nd edition. Informa Healthcare; 2011.
  23. SAS Global Forum. In: Figard S, editor. Paper 284-2009: The basics of experimental design for multivariate analysis. Abbott Park: Abbott Laboratories; 2009.
  24. ISPE Product Quality Lifecycle Implementation (PQLI) Guide: Overview of product design, development and realization: a science- and risk-based approach to implementation. http://www.ispe.org/index.php/ci_id/38143/la_id/1.htm.
  25. Garcia T, Cook G, Nosal R. PQLI key topics—criticality, design space, and control strategy. J Pharm Innov. 2008;3:60-. k" title="It opens in new window">CrossRef
  26. Michaels JN, Bonsignore H, Hudson-Curtis BL, Laurenz S, Lin H-RH, Mathai T, / et al. Attribute-based design space: material-science-based quality-by-design for operational flexibility and process portability. J Pharm Innov. 2011;6:193-01. k" title="It opens in new window">CrossRef
  27. Colgan ST, Watson TJ, Nosal R, Cunningham E. Leveraging API product knowledge and process understanding for successful development and commercialization. AAPS Annual Meeting. 2009.
  28. 21 CFR 314.50 (d) (1)(ii)(a). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.50.
  29. Pharmaceutical cGMPs for the 21st Century—A risk-based approach: second progress report and implementation plan. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836.
  30. Guidance for Industry: Extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070239.pdf.
  31. USP 34 General Chapter <1088> In vitro and in vivo evaluation of dosage forms. 2011.
  32. Guidance for Industry: Immediate release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070636.pdf.
  33. Guidance for Industry: SUPAC-MR: modified release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioequivalence documentation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070640.pdf.
  34. Guidance for Industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070246.pdf.
  35. Guidance for Industry: process validation: general principles and practices. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf.
  36. Process analytical technology—particle sciences technical brief 2012: volume 7. http://www.particlesciences.com/news/technical-briefs/2012/process-analytical-technology.html.
  37. CFR 210.3. kg/CFR-2011-title21-vol4/pdf/CFR-2011-title21-vol4-sec210-3.pdf" class="a-plus-plus">http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol4/pdf/CFR-2011-title21-vol4-sec210-3.pdf.
  
• 作者单位：Glenn A. Van Buskirk (1)
  Satish Asotra (2)
  Christopher Balducci (3)
  Prabir Basu (4)
  Gerald DiDonato (5)
  Angelica Dorantes (6)
  W. Mark Eickhoff (7)
  Tapash Ghosh (6)
  Mario A. González (8)
  Theresa Henry (9)
  Matthew Howard (10)
  Jason Kamm (11)
  Steven Laurenz (12)
  Ryan MacKenzie (13)
  Richard Mannion (14)
  Patrick K. Noonan (15)
  Terrance Ocheltree (6)
  Umesh Pai (16)
  Richard P. Poska (12)
  Michael L. Putnam (17)
  Ramani R. Raghavan (18)
  Colleen Ruegger (3)
  Eric Sánchez (19)
  Vinod P. Shah (20)
  Zezhi Jesse Shao (21)
  Russell Somma (22)
  Vijay Tammara (23)
  Avinash G. Thombre (24)
  Bruce Thompson (7)
  Robert J. Timko (25)
  Satyam Upadrashta (26)
  Sivakumar Vaithiyalingam (27)
  
  1. Nonclinical Drug Development Consulting Services, LLC, Basking Ridge, New Jersey, 07920, USA
  2. AHI Inc., Brampton, Ontario, Canada, L6W 4K4
  3. Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, USA
  4. National Institute of Pharmaceutical Technology and Engineering (NIPTE), Prospect, Illinois, 60056, USA
  5. Bristol-Myers Squibb Co., Pennington, New Jersey, 08534, USA
  6. Food & Drug Administration, Silver Spring, Maryland, 20993, USA
  7. Merck & Co., West Point, Pennsylvania, 19486, USA
  8. P’Kinetics International, Inc., Pembroke Pines, Florida, 33027, USA
  9. Old Greenwich, Connecticut, 06870, USA
  10. McNeil Consumer Healthcare, Ft. Washington, Pennsylvania, USA
  11. Summit Pharma Solutions, LLC, South Windsor, Connecticut, USA
  12. AbbVie, North Chicago, Illinois, 60064, USA
  13. Janssen Research & Development, LLC, Spring House, Pennsylvania, 19477, USA
  14. Purdue Pharma LP, Cranbury, New Jersey, 08512, USA
  15. PK Noonan & Associates, LLC, Williamsburg, Virginia, 23188, USA
  16. Sun Pharma USA, Cranbury, New Jersey, 08512, USA
  17. Boehringer-Ingelheim VetMedica, Inc., Saint Joseph, Missouri, 64506, USA
  18. Genentech, South San Francisco, California, 94080, USA
  19. Janssen Ortho, LLC., Gurabo, 00778, Puerto Rico
  20. North Potomac, Maryland, 20878, USA
  21. Arena Pharmaceuticals, San Diego, California, 92121, USA
  22. Somma Tech Consulting, Somerset, New Jersey, 08873, USA
  23. Nuron Biotech Inc., Exton, Pennsylvania, 19341, USA
  24. Pfizer Inc., Groton, Connecticut, 06340, USA
  25. AstraZeneca LP, Wilmington, Delaware, 19850, USA
  26. Millennium Pharmaceuticals, Cambridge, Massachusetts, 02139, USA
  27. Teva Pharmaceuticals, Pomona, New York, 10970, USA
  
• ISSN：1530-9932

文摘

In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-em class="a-plus-plus">in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.