International Pharmaceutical Quality

09/26/2024

ICH Quality Vision Update: PART VI on the Implementation of ICH Q12

IPQ News Alert: Monday, September 23, 2024

ICH’s 2003 Vision of a Harmonized Quality Regulatory Approach that Fosters Innovation Has Continued to Take form in 2023 and 2024

● INTRODUCTION

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024.... [Read More.]

[The introduction is openly available. Parts I-VI are available to subscribers.]

● PART I: Analytics Guidelines Q14 and Q2(R2)

● PART II: Viral Safety Guideline Q5A(R2)

● PART III: ICH Q1/Q5C Revision and In-Use Stability Evaluation

● PART IV: The Role of the New ICH CGT Discussion Group

● PART V: ICH's M4Q(R2) on the Quality Component of the CTD

● PART VI: The Implementation of ICH Q12

Part VI explores the intensified dialogue now taking place between industry and agency leaders on the challenges, opportunities and progress in using the tools and principles in the ICH Q12 lifecycle management guideline to advance the ICH objective of a more continuous improvement and innovation-friendly pharmaceutical quality regulatory environment.

The IPQ analysis draws from sessions focused on ICH Q12 implementation and the related ICH Q14 and M4Q initiatives at the ISPE October 2023 Annual Meeting, the 2024 CASSS WCBP Conference in January, the University of Georgia International GMP Conference in March, and the DIA Annual Meeting in June. The sessions included insights from key industry and regulatory agency experts involved in the development and implementation of Q12.

Subscribers can also access our latest postings on recent CMC/GMP regulatory developments by clicking:●Weekly Supplements ● "Updates in Brief" ● FDA warning letters ● EMA non-compliance reports, and ● FDA drug recalls.

Note from IPQ Editor-in-Chief Bill Paulson:

As explained in the introduction to the story, ICH articulated an overarching “Quality Vision” in 2003 calling for the development of “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.”

An ICH “Quality Discussion Group” (QDG) performed a comprehensive assessment of all existing ICH quality guidelines to identify gaps and in 2021 recommended additional guidance, standards, and training that would be needed over the next decade.

At issue was how ICH could best respond to the challenges being presented by: ● new therapeutic modalities ● innovative technologies ● the exigencies of accelerated patient access for unmet medical needs ● integration of ICH concepts into global inspection practices, and ● the needs of the expanding ICH membership.

In this story, IPQ has been exploring the key initiatives that have been high on the ICH quality agenda since 2023, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation.

Explored in Parts I-V are the ICH initiatives addressing: ● analytics (Q14 and Q2) ● viral safety (Q5A) ● stability (Q1, Q5C) ● cell and gene therapies, and ● the quality overall summary (M4Q). [See also IPQ January 11, 2023, and February 20, 2024 for in-depth reviews of ICH’s initiatives in the elemental impurities (Q3D) and risk management (Q9) arenas, respectively.]

The last part of our story focuses on where the global regulatory community is in implementing ICH Q12, whose guidance on lifecycle management and post-approval change is deeply interconnected with the principles and approaches covered in the other ICH quality guidelines and the current work on them.

The challenges of and progress in global adoption and implementation of ICH Q12 – a lynchpin in the ICH effort to support continuous improvement and innovation through its science and risk-based quality guidelines – have been front and center in the dialogue between industry and regulators at recent conferences.

In focus in Part VI is the strong light being shed on where the regulatory constraints lie and how to use Q12 in conjunction with the other ICH quality guidelines to seize the opportunities for more flexibility and international convergence.

In our upcoming coverage, IPQ will be further exploring the compelling stakeholder assessment and collaboration initiatives now advancing on the international stage, including those with which ICRMA, PIC/S, WHO and the International Pharmaceutical Regulators Programme (IPRP) are engaged. While there was a lot of effort to advance down the collaboration/harmonization pathway prior to the pandemic, the awareness of the urgency and opportunities for that advancement are paramount now in the industry/regulator conversations going on internationally. IPQ will be doing all it can to contribute to the communication needed to further the progress.

Over the last few weeks, IPQ’s staff has been immersed in the conference whirlwind that starts up in September. Among those IPQ attended in person in the Washington, DC area were the IPAC-RS inhaled biologics workshop, the PDA/FDA conference, the CASSS mass spec/higher order structure symposiums, and the CHPA regulatory, scientific and quality conference.

In Europe, meanwhile, Janine attended the MedTech & Pharma Platform annual conference in Basel, PDA’s manufacturing/legislation workshop in Berlin, and a TOPRA meeting on combined product regulation in Lund, Sweden.

This week, Bill will be attending the ASCGT policy summit in DC and the World Medical Innovation Forum in Boston, while Janine will be staying right at home in Gothenburg, Sweden to participate in the PDA conference on biomanufacturing. We have also been actively monitoring other meetings taking place on the virtual plain, which this week will include the IABS NGS meeting and an FDA workshop on generic drug development.

The meetings on the IPQ agenda for October are listed in our “Hotspots in the Dialogue” below and, along with those in November, on our homepage at IPQ.org.

If perhaps you and your colleagues have not been able to attend all of these meetings, analyze their contribution on the most pressing CMC/quality issues now on the table, and draw comparisons with the insights offered elsewhere by other key stakeholders in the international arena, let IPQ help out with these resource-intensive intelligence gathering, knowledge management, and external engagement challenges. We would very much value your support and your input in the IPQ efforts going forward.

Just contact Karen Bertani ([email protected], 415-806-7003), who will be happy to bring your organization on board for a reduced fee for 2025, and provide you with complimentary access for the rest of 2024, in appreciation for your commitment. And as always, many thanks to those organizations across the world that have already been supporting us in our mission to strengthen industry/regulator communications. We threw ourselves fully into that mission during the pandemic crisis, and we would be especially appreciative of your help in our efforts now to catch up on the pressing admin/fund raising needs that did not get enough attention as a result.

"Hotspots in the Dialogue"

IPQ’s upcoming meeting schedule through October includes:

● ASCGT Policy Summit (Sept 23-24) Washington, DC

● World Medical Innovation Forum (Sept 23-25) Boston, MA

● FDA SBIA Generics Workshop (Sept 24-25) Bethesda, MD

● DIA India Annual Meeting (Sept 24-25) Mumbai, India

● PDA Biomanufacturing Conference (Sept 24-25) Gothenburg

● IPEC Europe (Sept 24-25) Vienna, Austria

● DIA Latin America Annual Meeting (Sept 25-26) Brasilia, Brazil

● IABS Virtual Meeting on NGS (Sept 25-26) Virtual Only

● PDA Sustainability Workshop (Sept 26) Gothenburg, Sweden

● TOPRA Annual Symposium (Sept 30 – Oct 1) Rotterdam, Netherlands

● PDA Pharmaceutical Microbiology Conference (Oct 7-9) Washington, DC

● ARM Meeting on the Mesa (Oct 7-9) Phoenix, AZ

● PDA Alternative Microbio Methods Workshop (Oct 9-10) Washington, DC

● AFDO/RAPS Combination Products Summit (Oct 9-10) Providence, RI

● ISPE Annual Meeting (Oct 13-16) Orlando, FL

● ICDRA Conference (Oct 14-18) New Delhi, India

● PDA Aseptic Manufacturing Conference (Oct 15-16) Melbourne

● AAPS 2024 PHarmSCi 360 (Oct 20-23) Salt Lake City, UT

● AAM GRx+Biosims (Oct 21-23) Rockville, MD

● CASSS CMC Strategy Forum Europe (Oct 21-23) Rotterdam, NL

● APIC/CEFIC GMP & API Conference (Oct 23-24) Vienna, Austria

● PDA Pre-Filled Syringe and Inj. Devices (Oct 24-25) Phoenix, AZ

● PDA Combination Products Workshop (Oct 24-25) Phoenix, AZ

● DIA/FDA Oligo Conference (Oct 28-30) Washington, DC

● PDA Aseptic Processing Conference (Oct 29-30) Incheon, Korea

See IPQ.org for our meeting schedule through November.

International Pharmaceutical Quality

IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. For information on subscribing click here or contact Karen Bertani ([email protected]).

https://ipq.org/ichs-2003-vision-of-a-harmonized-quality-regulatory-approach-that-fosters-innovation-continued-to-take-form-in-2023-and-2024/

































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The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The goal is not a new one for ICH but was clearly articulated back in 2003 in an overarching “Quality Vision” calling for the de...

09/18/2024

Featuring EMA's Palmi on International Reliance


Note from IPQ Editor-in-Chief Bill Paulson:

Featured in this Weekly Supplement is a thought-provoking discussion by EMA Senior International Affairs Officer Victoria Palmi Reig at the June DIA Southeastern Europe Conference of how the EU processes and experience can be brought to bear in furthering international collaboration and reliance.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.

CLICK HERE to view the issue.



International Pharmaceutical Quality
IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. For information on subscribing click here or contact Karen Bertani ([email protected]).

09/16/2024

Featuring FDA CBER Reviewer Schulte on Deploying Rapid Microbial Methods

Note from IPQ Editor-in-Chief Bill Paulson:

In this Weekly Supplement, IPQ focuses on a discussion at the May FDA Regulatory Education for Industry (REdI) annual conference by CBER reviewer and standards expert Seth Schulte on the evaluation and implementation of rapid microbial methods (RMMs). He discussed: ● the RMM regulatory space ● RMM validation ● relevant compendial coverage and agency guidance, and ● common deficiencies observed with the development of RMMs. Companies that are deploying RMMs in product/process development or considering changing to them will find Schulte’s insights highly valuable.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.

International Pharmaceutical Quality

IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. For information on subscribing click here or contact Karen Bertani ([email protected]).

09/13/2024

Featuring EMA's Conocchia on Implementing the Annex 1 Revision

Note from IPQ Editor-in-Chief Bill Paulson:

Our feature story in this Weekly Supplement focuses on a review by EMA GMP Technical Lead Roberto Conocchia at a recent PDA Good Aseptic Manufacturing Conference of international collaborative efforts to align on implementing the Annex 1 revisions, including those of EMA’s GMDP Inspectors Working Group and the PICS/EMA/WHO Joint Implementation Working Group.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.

International Pharmaceutical Quality

IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. For information on subscribing click here or contact Karen Bertani ([email protected]).

09/12/2024

Featuring FDA Compliance Official Higgins on Aseptic Manufacturing Findings

Note from IPQ Editor-in-Chief Bill Paulson:

In this Weekly Supplement, we bring you more regulator insights from PDA Europe’s mid-May conference on good aseptic manufacturing practice. Featured is the presentation by FDA CDER compliance official Brooke Higgins in which she reviewed FDA aseptic processing inspection trends and offered advice on how companies should be addressing related issues in their operations.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.

International Pharmaceutical Quality

IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. For information on subscribing click here or contact Karen Bertani ([email protected]).

09/11/2024

Featuring EU GMP Inspector Meissner on Annex 1 Implementation Findings

Note from IPQ Editor-in-Chief Bill Paulson:

At the May 2024 PDA Good Aseptic Manufacturing Conference, Austrian (AGES) GMP inspector Christina Meissner reviewed the shortfalls that inspections are revealing with Annex 1 implementation since it came into force in August 2023. Our feature story provides a lot of valuable insights from Meissner on the do’s and don’ts of applying quality risk management, deploying contamination control strategies, transferring materials, and process retrofitting and the deployment of emerging aseptic technologies.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.

https://ipq.org/wp-content/uploads/2024/07/IPQ_2024_06_21_Weekly.pdf

International Pharmaceutical Quality

IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

Subscription fees and other funding, in turn, allow IPQ to provide significant pro bono promotional and coverage-related support to regulatory agencies/networks, public-private partnerships, and non-profit organizations and associations most directly involved in the global CMC/quality dialogue. For information on subscribing click here or contact Karen Bertani ([email protected]).

08/06/2024

Please visit us at IPQ.org.

https://ipq.org/

07/23/2024

IPQ Monthly Update – January and February 2024 in Review

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The January/February Monthly Update provides the first three parts of an exploration by IPQ of the key initiatives that are high on the ICH quality agenda since 2003, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation. The ICH guideline projects that are explored in these three parts address: ● analytics (Q14 and Q2(R2)) ● viral safety (Q5A(R2)), and ● stability (Q1, Q5C).

Subscribers can also access our latest postings on recent CMC/GMP regulatory developments by clicking:●Weekly Supplements ● "Updates in Brief" ● FDA warning letters ● EMA non-compliance reports, and ● FDA drug recalls.



Note from IPQ Editor-in-Chief Bill Paulson:

IPQ has been focused heavily this year on our Weekly Supplement initiative. We are now turning attention to catching up on our in-depth stories and the Monthly Updates for the first half of the year beginning with our January/February issue.

Along with our in-depth stories, the Monthlies will include the featured “Insights from Leading Regulators” that went out in the Weekly Supplements during that timeframe and have not already been incorporated into in-depth stories.

IPQ’s January/February Monthly Update features the introduction and first three parts of our in-depth exploration of how the ICH effort to evolve its quality guideline series to keep pace with innovation has been progressing (see pp. 4-40).

Provided are insights from Expert Working Group (EWG) members on the initiatives that have been high on the ICH quality agenda since 2023, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation.

Part I focuses on ICH’s new analytical development guideline Q14 and a significant revision of its analytical validation guideline Q2(R1).

In focus in Part II is ICH’s recently released viral safety evaluation guideline Q5A(R2), including the principles and objectives of and public comments on the revision, key updates, and the guideline’s implementation.

The third part homes in on the revision project now underway on the ICH Q1A-F and Q5C stability guidelines and some of the considerations on the table for in-use stability, in particular.

The remaining parts of our ICH update story will follow in the next two Monthly Updates. They address: ● the role that is being played by the newly formed CGT Discussion Group ● the revision of ICH’s M4Q(R1) guideline on the quality component of the CTD, and ● the lifecycle management/post-approval change issues related to implementing ICH Q12.

Also included in the January/February Monthly are four stories that were featured in IPQ Weekly Supplements during the two months (see pp. 41-98). Three of these stories provide “current insights from leading regulators” on: ● FDA’s 2024 strategic priorities for combination products including global regulatory collaboration and convergence ● EMA’s perspective regarding advanced manufacturing digitalization, and ● global advancement and convergence of CMC practices. The fourth covers an FDA leader on the role of the agency’s generic drug and biosimilar research programs.

Among the many regulatory developments outlined in the “Updates in Brief” section of the issue (see pp. 99-113) is the expansion of the FDA/EMA Parallel Scientific Advice program to include complex generics. Also highlighted are WHO initiatives on biomanufacturing workforce training and an updated and expanded edition of its medical product GMP compendium.

There were 18 drug GMP warning letters posted by FDA during January and February (see pp. 114-125) — seven addressing US operations and 11 to foreign facilities.

Two of the US letters went to compounders, four to finished drug dosage forms and one to an HCT/P producer. The latter five all included citations for component testing. Among the foreign recipients were eight finished dose and three API manufacturers. Component testing was cited in five of the 11, and data integrity in three.

The recalls during the Jan./Feb. period (see pp. 127-131) continued at a very similar pace to the previous two months — 59 vs. 60 during Nov./Dec. The number of Class I’s was also similar — 14 vs. 15.

The leading cause among the Jan./Feb. recalls was cGMP deviations creating the potential for contamination or product degradation – with over one-quarter of them (15) in this category. The next leading category was impurity/foreign substance/particulate problems, for which there were 13 recalls – five of which were rated Class I. The Class I’s involved three sprays with benzene contamination and two injectable products with glass particulates.

All four of those not complying with NDA/ANDA requirements were rated Class I – three capsule products containing sexual enhancement drugs, and the fourth, a tablet, containing the unapproved substance tianeptine. Two of the other Class I’s involved a potentially leaking container for a powder and a labeling mix up. The remaining Class I involved an injectable with a potentially malfunctioning semi-automated IV bag filling system.

Last week, Nathan and I were in attendance at the CASSS Summer CMC Strategy Forum, which explored the expanding world of bioconjugates. This week Nathan is at the AAPS Summer Scientific Forum in Kansas City, Missouri.

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The January/February Monthly Update provides the first three parts of an exploration by IPQ of the key initiatives that are high on the ICH quality agenda since 2003, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation. The ICH guideline projects that are explored in these three parts address: ● analytics (Q14 and Q2(R2)) ● viral safety (Q5A(R2)), and ● stability (Q1, Q5C).

Subscribers can also access our latest postings on recent CMC/GMP regulatory developments by clicking:●Weekly Supplements ● "Updates in Brief" ● FDA warning letters ● EMA non-compliance reports, and ● FDA drug recalls.



Note from IPQ Editor-in-Chief Bill Paulson:

IPQ has been focused heavily this year on our Weekly Supplement initiative. We are now turning attention to catching up on our in-depth stories and the Monthly Updates for the first half of the year beginning with our January/February issue.

Along with our in-depth stories, the Monthlies will include the featured “Insights from Leading Regulators” that went out in the Weekly Supplements during that timeframe and have not already been incorporated into in-depth stories.

IPQ’s January/February Monthly Update features the introduction and first three parts of our in-depth exploration of how the ICH effort to evolve its quality guideline series to keep pace with innovation has been progressing (see pp. 4-40).

Provided are insights from Expert Working Group (EWG) members on the initiatives that have been high on the ICH quality agenda since 2023, the progress that has been made in advancing them, and what remains to be done in guideline creation, revision, and implementation.

Part I focuses on ICH’s new analytical development guideline Q14 and a significant revision of its analytical validation guideline Q2(R1).

In focus in Part II is ICH’s recently released viral safety evaluation guideline Q5A(R2), including the principles and objectives of and public comments on the revision, key updates, and the guideline’s implementation.

The third part homes in on the revision project now underway on the ICH Q1A-F and Q5C stability guidelines and some of the considerations on the table for in-use stability, in particular.

The remaining parts of our ICH update story will follow in the next two Monthly Updates. They address: ● the role that is being played by the newly formed CGT Discussion Group ● the revision of ICH’s M4Q(R1) guideline on the quality component of the CTD, and ● the lifecycle management/post-approval change issues related to implementing ICH Q12.

Also included in the January/February Monthly are four stories that were featured in IPQ Weekly Supplements during the two months (see pp. 41-98). Three of these stories provide “current insights from leading regulators” on: ● FDA’s 2024 strategic priorities for combination products including global regulatory collaboration and convergence ● EMA’s perspective regarding advanced manufacturing digitalization, and ● global advancement and convergence of CMC practices. The fourth covers an FDA leader on the role of the agency’s generic drug and biosimilar research programs.

Among the many regulatory developments outlined in the “Updates in Brief” section of the issue (see pp. 99-113) is the expansion of the FDA/EMA Parallel Scientific Advice program to include complex generics. Also highlighted are WHO initiatives on biomanufacturing workforce training and an updated and expanded edition of its medical product GMP compendium.

There were 18 drug GMP warning letters posted by FDA during January and February (see pp. 114-125) — seven addressing US operations and 11 to foreign facilities.

Two of the US letters went to compounders, four to finished drug dosage forms and one to an HCT/P producer. The latter five all included citations for component testing. Among the foreign recipients were eight finished dose and three API manufacturers. Component testing was cited in five of the 11, and data integrity in three.

The recalls during the Jan./Feb. period (see pp. 127-131) continued at a very similar pace to the previous two months — 59 vs. 60 during Nov./Dec. The number of Class I’s was also similar — 14 vs. 15.

The leading cause among the Jan./Feb. recalls was cGMP deviations creating the potential for contamination or product degradation – with over one-quarter of them (15) in this category. The next leading category was impurity/foreign substance/particulate problems, for which there were 13 recalls – five of which were rated Class I. The Class I’s involved three sprays with benzene contamination and two injectable products with glass particulates.

All four of those not complying with NDA/ANDA requirements were rated Class I – three capsule products containing sexual enhancement drugs, and the fourth, a tablet, containing the unapproved substance tianeptine. Two of the other Class I’s involved a potentially leaking container for a powder and a labeling mix up. The remaining Class I involved an injectable with a potentially malfunctioning semi-automated IV bag filling system.

Last week, Nathan and I were in attendance at the CASSS Summer CMC Strategy Forum, which explored the expanding world of bioconjugates. This week Nathan is at the AAPS Summer Scientific Forum in Kansas City, Missouri.

"Hotspots in the Dialogue"

IPQ’s upcoming meeting schedule through August includes:

● AAPS Summer Scientific Forum (July 22-25) Kansas City, MO
● CASSS CMC Latin America (Aug 6 and 13) Virtual Only
● Bioprocessing Summit (Aug 19-22) Boston, MA
● Duke Margolis Submission Meeting (Aug 20) Washington, DC
● USP Extractables and Leachables (Aug 26) Virtual Only
● ISPE Singapore Conference (Aug 28-30) Suntec, Singapore

See IPQ.org for our meeting schedule through October.

IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums – along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena – to create a uniquely valuable resource for the intelligence gathering, knowledge management, and communication needs of the pharmaceutical community.

Dedicated to helping its readers keep up with and influence the changes to quality regulation as it evolves to match the fast-moving process and product technologies, IPQ provides the depth and breadth of intelligence needed to form strategies, make decisions, and take the right action. The investment in an organization-wide subscription, which allows IPQ’s content to be openly shared internally, is small compared to the benefits and resource-saving potential that IPQ offers.

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https://ipq.org/ipq-monthly-update-january-february-2024-in-review/

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024. The January/February Monthly Update provides the first three parts of an exploration by IPQ of the key initiatives that are high on....