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Global Regulators Discuss Remote/Distant Assessments, Audits, & Regulatory Guidance at ISPE Summit

Robert W. Tribe
Global Regulators Discuss Remote/Distant Assessments, Audits, & Regulatory Guidance at ISPE Summit

This virtual ISPE Global Pharmaceutical Regulatory Summit, held on 28 April 2021, brought together eleven regulators from different parts of the world to discuss how their approach to GMP inspections have adapted to the COVID-19 pandemic. Such a large number of regulators at a single forum is unprecedented for ISPE.

The regulators participating in this Summit were:

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
Brendan Cuddy
Lead Scientific Officer
David Churchward
Head of Operations Quality, Compliance and External Affairs
Anne Hayes
Inspection Manager, Compliance and PIC/S Chair
Carmelo Rosa, PsyD
Director, Division of Drug Quality I
Joey Gouws, PhD
Team Lead, Inspection Services, Prequalification Team
World Health Organization
Vladislav Shestakov
Deputy Head of the Russian State GMP Inspectorate
Russia State Institute of Drugs and Good Practices
Manuel Ibarra Lorente
Head of Pharmaceutical Inspection & Enforcement Department
AEMPS (Spanish Agency of Medicines and Healthcare Products)
Jacques Morenas
Technical Advisor of the Inspection Division Director
Klaus Eichmueller
Darmstadt Regional Council
Regierungspräsidium Darmstadt
Marisa Delbo
AIFA Consultant As former Head of GMP API Inspections and Manufacturing

A panel discussion involving all eleven regulators was preceded by four keynote presentations giving an update on the current approaches used by US FDA, EMA, MHRA, HPRA and PIC/S for remote/distant inspections.

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations

In his keynote presentation, Alonza Cruse (USFDA) indicated that although on-site inspections remained the “gold standard”, the pandemic had forced FDA to re-think its approach to inspections by using a risk-based approach involving various oversight tools, including:

FDA is using the term “Remote Interactive Evaluation” to distinguish a remote evaluation from an on-site inspection.

Cruse said that the remote evaluation would be hosted by FDA using an FDA version of MS Teams, Zoom or Adobe as the IT platform. A written list of observations would follow the remote evaluation, but FDA 482 and FDA 483 forms would not be used.

Cruse indicated that once the pandemic was over, FDA would go back to on-site inspections but would likely use a hybrid approach by including a remote interactive evaluation component.

Brendan Cuddy
Lead Scientific Officer

In his presentation, Brendan Cuddy (EMA) indicated that the pandemic had created a challenge to GMP inspectors who needed to ensure ongoing verification of GMP compliance was being maintained. EMA recognized the need for regulatory flexibility until the end of the pandemic, using approaches such as automatic extension of the validity dates for GMP certificates and product specific GMP flexibility for crucial medicines and process validation.

Cuddy said that a distant assessment guidance document to directly verify GMP compliance had been developed and published in October 2020 by EMA (see Guidance related to GMP GDP and PMF distant assessments_version1 ).This guidance document contained a definition for “distant assessment” as well as guidance for the planning, preparation, conduct and post-assessment phases of the distant assessment.

Cuddy indicated that distant assessments have broad application and can be performed for all types of sites, dosage forms and pre-approval inspections, and can result in the granting of GMP certificates – but with the certificate indicating that the determination was based on a remote assessment. He emphasized that a distant assessment does not replace an on-site inspection, which should be conducted when circumstances permit. He said that if a distant inspection does not permit the granting of a GMP certificate, a clock-stop would be triggered until an on-site inspection was possible.

Cuddy indicated that distant assessments would only be undertaken where:

  • The site was able to facilitate and support the assessment.
  • The necessary resources and IT capabilities were available.
  • The necessary personnel (including translators) were available and management support and leadership were on-site.

Cuddy said that for new sites or for pre-approval inspections, if any critical deficiencies were identified, the relevant application would be put on hold until an on-site inspection could be performed. For other types of distant assessments, if any critical deficiencies were identified a statement of non-compliance may be issued.

Since April 2020, EMA had coordinated 34 distant assessment – all with positive outcomes. In EU overall the national competent authorities have conducted 202 distant assessments since the start of the pandemic up to 31 March 2021. Of these, 37 sites were located outside EU while 165 sites were within EU – all with positive outcomes.

Cuddy concluded by saying that:

  • Distant assessment has proven to be a useful tool in the supervisory toolbox;
  • Good positive feedback had been received from inspectors and inspected companies on the conduct and results of distant assessments to date;
  • Distant assessments provide an additional control measure to verify compliance;
  • The future will see more international authority use of distant assessment.
  • Distant assessment will not replace on-site inspection

David Churchward
Head of Operations Quality, Compliance and External Affairs

In his presentation, David Churchward (MHRA) discussed current and future challenges arising from the pandemic. Current challenges include severe travel restrictions, global supply pressures and backlog of GMP inspections. Future challenges when the pandemic is over would likely include the development of regulatory approaches to a digital environment and the harmonization of remote assessments between regulators to create an environment of reliance.

Churchward asked whether the regulatory changes arising from the pandemic are here to stay, including remote assessments. It was his belief that because a distant assessment was a rapid and flexible monitoring tool, it would continue to be used after the pandemic, but in a hybrid form; particularly for low-risk situations.

He gave an overview of MHRA’s regulatory approach for the future, which would likely include more work to refine distant assessment tools, the development of AI (artificial intelligence) guidance for pharmacovigilance monitoring and innovative licensing & access pathways. This last-mentioned initiative aims to accelerate time to market, facilitating patient access to new medicines (see Innovative Licensing and Access Pathway).

Anne Hayes
Inspection Manager, Compliance and PIC/S Chair

In her presentation, Anne Hayes (HPRA & PIC/S Chair) indicated that PIC/S was an informal cooperative scheme that had been operating for 50 years, comprising 54 member authorities coming from all over the world (Europe, Africa, Americas, Asia & Australasia). Membership of PIC/S enabled member authorities to share information of GMP-related topics, including GMP inspection reports (see Pharmaceutical Inspection Co-operation Scheme about).

She stated that PIC/S held a training Seminar for inspectors each year, with the most recent Seminar in December 2020 covering the topic of Distant Assessment. During this Seminar the results of a survey amongst the 54 PIC/S member authorities were presented, which revealed that:

  • The terminology used for off-site GMP assessments varies;
  • For domestic inspections, 69% of member authorities who responded were able to conduct on-site inspections during the pandemic, while 57% were using distant inspections and 57% were using hybrid inspections; and
  • For foreign inspections, only 14% of member authorities who responded were able to conduct on-site inspections, while 38% were using distant inspections.

Hayes said that the survey had also revealed that MS Teams and Webex were the most popular applications used for distant assessments, with 66% of member authorities arranging the video connections themselves. The survey also revealed that 33% of inspectors showed their identity card by video to the company during the distant assessment.

The survey also revealed that only 28% of member authorities who responded will continue to use distant assessment for some activities, while 47% had not decided their post-pandemic plans.

According to Hayes, seminar participants indicated their strong support for the development of guidelines and tools to harmonize procedures for distant inspections in order to facilitate continued reliance between international regulatory partners. She said that PIC/S had formed a Working Group to commence work on the preparation of these guidelines, tools and training.

Tom Hartman
President & CEO

Following these four keynote presentations, a two-hour panel discussion involving all eleven regulators took place. The panel discussion was jointly moderated by Thomas Hartman (President & CEO, ISPE) and Thomas Zimmer (Vice President, European Operations, ISPE). Attendees were able to submit questions for the panelists prior to and during the live event. Questions addressed by the panelists included:

  • What are the criteria for choosing different approaches: on-site inspection, remote/distant assessment, "paper" audit/assessment?
  • What elements of distant assessments have worked well and what has been difficult?
  • Have you seen a difference in volume or types of issues found with distant assessments?
  • Do you have any preferred technologies or platforms for conducting distant assessments?
  • How will GMP certificates and/or a PAI during public health emergencies be issued?
  • How are agencies using remote/distant assessment/inspection information collected by other regulatory agencies?
  • Will regulators accept virtual audits of suppliers by pharmaceutical companies and how will they judge the effectiveness of those audits?
  • What aspects of the remote inspections do you see continuing in the future? What workforces need do you foresee?
Thomas Zimmer, PhD
VP European Operations

Look for the panelists’ replies to these and other questions in a more detailed article in a future issue of Pharmaceutical Engineering magazine. Overall, this was an excellent and informative session with extensive amounts of information and insights delivered to attendees.

Another ISPE Global Pharmaceutical Regulatory Summit will take place on 16 June 2021 with a focus on Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders.

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This is brief and informal synopsis of a discussion among regulators from various countries and regulatory organizations during the ISPE Global Pharmaceutical Regulatory Summit on 28 April 2021. It has not been vetted by any of the agencies or regulators cited in this article.