Drug Master File (DMF) and Drug Substance Workshop
March 3 & 4, 2021
Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principals throughout the API lifecycle. This conference is designed to provide an update on current Agency initiatives and will cover a wide variety of topics of interest to API manufacturers and regulators. Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, panel discussions, and Q&A for two poster sessions. The desired outcome is to outline the various regulatory steps necessary for the successful development of a high-quality submission of drug substance information to the Agency.
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The agenda may be updated as changes to the schedule occur. The currents version is Version 4, updated on January 8, 2021. |
The speaker biographies document provides information on the speakers participating in the Workshop. |
ZIP of Follow-Up Webinar Slides
Session Recordings:
Day One:
- Welcome – Lawrence Yu
- Introduction to the DMF Review Process – Erin Skoda
- Administrative Aspects of Managing a DMF – Vathsala Selvam
- Q&A Panel for above sessions
- Managing Electronic DMF Submissions – Jonathan Resnick
- Drug Master Files from a GDUFA II User Fee Perspective – Hanah Pham & Evelyn Hong
- Timely Consult and Early Information Request (TCIR) Process for Drug Master Files (DMFs) – Jayani Perera
- Effective Communication Strategies for Drug Master Files (DMF) – David Skanchy & Benjamin Danso
- Q&A Panel for above sessions
- Poster Presentations: Responses to Submitted Questions (Day One)
- Drug Substance Facilities – Hidden and Critical Intermediate – Cassandra Abellard & Wei Liu
- ICH Q11 Q&A, a Supporting Document for the Selection and Justification of Starting Materials – Anita Tiwari
- Q&A Panel for above sessions
- Common Issues Related to LC and GC Methods in Type II DMFs – Xinghua Wu
- Process Validation and ICH Q7 – David Amspacher
- Regulatory Considerations in Demonstrating Complex API Sameness – Bapu R. Gaddam
- Q&A Panel for above sessions
Day Two:
- Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD – Hongbiao Liao
- ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment – Barbara O. Scott
- Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification – Naomi L. Kruhlak
- Q&A Panel for above sessions
- Safety Evaluation of Drug Substance Impurities in Generics – Chanchal Gupta
- Nitrosamines: Where Are We Now? – Deborah F. Johnson
- Q&A Panel for above sessions
- Poster Presentations: Responses to Submitted Questions (Day Two)
- API Facility Inspections – Jay Jariwala
- Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence – Brian Connell
- Q&A Panel for above sessions
- Common CMC Issues in Type II DMFs and How to Avoid Them – Wei Liu
- Modernizing Drug Substance Assessment through KASA – Larisa Wu
- Q&A Panel for above sessions
- Workshop Closing Remarks – David Skanchy
Follow-Up Webinar Recordings:
In addition to the presentations during the 2-day Conference, there are 19 pre-recorded Poster Presentations on a variety of topics.
* Download PDFs of the Posters *
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The Poster Presentations |
View the Presentation |
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1. Timeline for the DMF review process (basic primer on how we align with ANDA) Authors: Wei Song, Steve Kinsley. Alignment of the DMF review process with the ANDA review process and timelines will be covered. |
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2. Completeness Assessments (CAs): Current CA Status, KASA for CA, Common Issues & GDUFA Commitment Letter Statistics Authors: Yingzi Wang, Jayani R. Perera, Jason Crawford, Larisa Wu, and Xiang Yu. This poster discusses CA statistics, application of KASA, and advice for improving the CA outcome. |
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3. Metrics on DMF Assessments Authors: Steve Kinsley, Wei Song. DMF statistics including adherence to due dates and overall productivity will be presented. |
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4. Introduction to FDA Drug Master File Form 3938 Authors: Vathsala Selvam and CDR David Skanchy. The new FDA DMF form 3938, similar to the application 356h form, will be presented. View full 29-minute full length webinar: Drug Master Files(DMF) Submissions on New FDA Form 3938 |
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5. Cocrystal APIs: Recommended Documentation Authors: Weiqin Jiang, Neeru Takiar, and Ramnarayan Randad. A discussion of API sameness with regard to cocrystal APIs will be covered. |
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6. Synthetic Therapeutic Polymers: Recommended documentation for API sameness Authors: Bapu R. Gaddam, Ramnarayan Randad, Benjamin Lim, David Skanchy. Regulatory strategies to establish API sameness of cross coupled polymers. |
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7. Synthetic Therapeutic Peptide APIs: Recommended documentation for API sameness & related impurities Authors: Suresh Jayasekara, Manivannan Ethirajan, David Green, and Ramnarayan Randad. Practical advice on achieving API sameness in peptide drug substances is provided. |
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8. Regulatory Considerations for Synthetic and Semi-synthetic Oligosaccharide Complex APIs in Generic Products Authors: Keduo Qian, Barbara Scott, Govindaraj Kumaran, Weixiang Dai, CDR David Skanchy. We will present the Agency’s current thinking on the active ingredient sameness assessment of oligosaccharide complex APIs in generic and reference products. |
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9. Quality Considerations for Continuous Manufacturing of APIs Authors: Anjali Bain, Yun J. Wang, Ramnarayan Randad, David Skanchy, Adil Mohammad, Raymond Frankewich, and Thomas O’Connor. This poster is based on the draft guidance Quality Considerations for Continuous Manufacturing and provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule drug substances. |
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10. ANDA Aligned Teams Authors: Steve Kinsley, Wei Song. The new Integrated Quality Assessment (IQA) alignment of teams to facility collaborative review will be presented. |
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11. Review of Secondary Type II Drug Master Files Authors: Madhusudhan Gowravaram & David Skanchy. This poster will discuss the risk-based review approach for the acceptance of secondary DMFs for the adequacy of primary DMFs supporting A/NDAs and some regulatory aspects of secondary DMFs. |
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12. USP Pending Monograph Process and USP compliance for Industry Authors: Yan Ma, Yun J. Wang, Anita Tiwari, Barbara Scott. This poster provides information on FDA’s current thinking on the USP-PMP and recommendations for drug master file (DMF) holders. |
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13. Evaluation of Metal Impurities in Drug Substances Authors: Donglei Yu, Mst Hasina Akter, Wei Liu, Ramnarayan Randad. The risk assessment for elemental impurities in drug substances and atypical drug substances will be discussed. |
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14. Mutagenic Impurities from a Drug Substance Perspective: Highlights from the ICH M7 Question and Answer Draft Document Authors: David Green, Barbara Scott, CDR David Skanchy. We will highlight four topics covered in the new ICH M7 Question and Answer Draft Document surrounding the control of mutagenic impurities. |
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15. Establishing Impurity Acceptance Criteria as Part of Specifications for DMFs Based on Clinical Relevance Authors: Yongjun Gao, Ramnarayan Randad, David Green, Weixiang Dai, Hongbiao Liao and David Skanchy. Advice on establishing impurity limits in various cases is provided. |
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16. API Manufacturing Global Distribution and Facility Profile Analysis Authors: Wei Song, Ying Zhang, Nathan Chen, and CDR David Skanchy. We will discuss the diverse and complex global API supply chain. |
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17. Communications with DMF Holders and Applicants throughout the DMF Lifecycle Authors: Fatima C. Sequeira, Vathsala Selvam, Claude Theophin, Terrence Nichols, Ben Danso, David Skanchy. We will review available pathways, that DMF holders and applicants can communicate with Agency. |
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18. The DMF Teleconference Process Authors: Benjamin Danso and Jayani Perera. The current process for requesting, granting, and executing a DMF teleconference will be described along with data and metrics for the process from GDUFA I to present. |
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19. List of Relevant Quality Guidances & Common Deficiencies Observed during Drug Master File Review Authors: Sad Ahamed and Mahmut Levent. This poster provides a non-exhaustive list of relevant technical guidance applicable to DMFs and discuss common deficiencies. |
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