The document discusses how COVID-19 has changed pharma and biopharmaceutical audits, with remote audits now accepted by regulatory authorities. It explores the benefits of different audit approaches like remote, virtual, and hybrid audits and the features that enable each. Regulatory bodies are adopting new guidance for remote inspections and assessments. Looking ahead, risk-based planning and digital solutions will allow the industry to conduct more flexible and agile audits, though on-site audits will still be necessary at times. Hybrid audits combining various approaches are positioned as the future of auditing.

1. Daniel Buescher
4th of August 2022
The Future of
Pharma- and
Biopharmaceutical
Audits

2. Classification: Public
2
The Life Science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.

3. Classification: Public
Covid-19 Changes the Pharma- and Biopharmaceutical
Audits
The Future of Pharma- and Biopharmaceutical Audits | 04.08.2022
3
And There’s No Going Back
1. Remote Audits can be done.
2. Accepted by Regulatory Authorities.
3. Industry wants to continue to be flexible, agile and fast.
Lessons Learned
Hannah Chudleigh, March 9th, 2022
Source https://www.biospace.com/article/cutting-commutes-and-adopting-ai-how-covid-19-has-changed-the-biopharma-industry-/

4. Classification: Public
Regulatory view – GAO
Remote & live
interactions technologies
are in the spot of FDA
The Future of Pharma- and Biopharmaceutical Audits | 04.08.2022
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Source https://www.gao.gov/products/gao-21-409t

5. Classification: Public
Regulatory view – FDA
Source https://www.fda.gov/media/147582/download
Guidance for remote
interactive tools
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6. Classification: Public
Regulatory view – EDQM remote inspections
Source https://www.edqm.eu/en/news/edqm-remote-inspections-pilot-phase-permanent-element-edqms-inspection-scheme
European Directorate for
the Quality of Medicines &
HealthCare (EDQM) works
on remote inspection pilot.
The Future of Pharma- and Biopharmaceutical Audits | 04.08.2022
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7. Classification: Public
Regulatory view – EMA guidance for distance
assessments
Source https://www.ema.europa.eu/en/documents/scientific-guideline/guidance-related-gmp/gdp-pmf-distant-assessments_en.pdf
Guidance for distance
assessments from EMA
Distance assessments
may reduce On-Site
intervals
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8. Classification: Public
Challenges
Due to inability to perform On-Site audits
Unclear authority
drug registration
status
Unclear qualification &
clearance processes
Unclear release of
batches
Unclear drug
registration status
1
2
3
4
Challenges
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9. Classification: Public
On-Site & Off-Site Features
Customer
request and
scheduling
Internal
organization
Confidentiality
Disclosure
Agreement
Information
sharing
Face to Face
Secure
document
exchange space
Live communication
features like chat, audio
and video call option
Live video tour
feature on site
Prerecorded
3D or virtual
tours of site
On-Site common
Off-Site digital
+

10. Classification: Public
Secure document exchange space
Sharing confidential information need secure data exchange space
SME Auditor
SME Auditor
View
only
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11. Classification: Public
Live communication features
Secure meetings using video communication tool.
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12. Classification: Public
Live video tour feature
Advanced communication platform using
video glasses and augmented reality to
have live remote tour.
Picture source AMA XpertEye
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13. Classification: Public
Prerecorded 3D virtual tours of site
Virtual walk-through 3D
models of sites, facilities,
plants or labs
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14. Classification: Public
Prerecorded 3D virtual tours of site
Show video here
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15. Classification: Public
Disclaimer
The 360° scans for
M Lab TM Collaboration Centers
will be released for public use later this year.
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16. Classification: Public
Information
&
Communication
Technology
Audit terminologies
On-Site
Audit
Data
Room
Audit
Virtual
Audit
Remote
Audit
Terminologies
Desktop
Inspection
Audit
Distance
Assessment
eAudit
Document /
ePaper Audit
2-Phase
Audit
Surrogate
Audit
(Min. 2
Auditors,
one On-Site
one Off-
Site)
ICT
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17. Classification: Public
Audit feature options summery
On-Site
Audit
Data
Room
Audit
Virtual
Audit
Remote
Audit
Terminologies
Information
&
Communication
Technology
ICT
Scheduling
Organization
Secure document
exchange
Information
CDA
Virtual 3D recordings
Live video tour
Live communication
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18. Classification: Public
On-Site Audit
SME
Audi-
tor
On-Site
On-Site
Audit
Tool
Audi-
tor
Off-Site
Established audit method
Preferred for critical issues
Preferred method for qualifications audit
Face to face meeting
Scheduling
Organization
Secure document
exchange
Information
CDA
Virtual 3D recordings
Live video tour
Live communication
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19. Classification: Public
Data Room Audit
On-Site
Data
Room
Audit
Tool
Audi-
tor
SME
Independent
Off-Site
Paper audit digitalized
Better and easy preparation for auditor
Time independent
Secure document exchange
Questions can prepare to use SME time most efficient
No travel time & costs
Scheduling
Organization
Secure document
exchange
Information
CDA
Virtual 3D recordings
Live video tour
Live communication
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20. Classification: Public
Remote Audit
On-Site
Remote
Audit
Tool
Live
Audi-
tor
SME
Off-Site
On-Site audit digitalized
Comparable to On-Site audit
Easier SME interaction
Location changes can easily be handled
No travel time & costs
Scheduling
Organization
Secure document
exchange
Information
CDA
Virtual 3D recordings
Live video tour
Live communication
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21. Classification: Public
Virtual Audit
On-Site
Virtual
Audit
Tool
Independent
SME
3D
Audi-
tor
Off-Site
Independent On-Site audit digitalized
No travel time & costs
Time independent
Can be done prior to an On-Site audit
Questions can prepare to use SME time most efficient
Scheduling
Organization
Secure document
exchange
Information
CDA
Virtual 3D recordings
Live video tour
Live communication
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22. Classification: Public
Audit execution options summery
SME
Audi
-tor
On-Site
On-Site
Audit
Desktop
Audit
Virtual
Audit
Remote
Audit
Tool
Audi
-tor
SME
Audi
-tor
Independent
Independent
Live
Audi
-tor
SME
SME
3D
Audi
-tor
Off-Site
Hybrid
Audit

23. Classification: Public
Regulatory view – Regulatory Focus
Source
https://www.raps.org/news-and-articles/news-articles/2022/6/fda-official-virtual-audits-records-requests-may-b
FDA plans to use hybrid inspection model
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24. Classification: Public
Risk based audit approach
High Medium Low
Desktop
&
Virtual
Remote
In case of high risk
rating On-Site audits
are preferred method
In case of medium
risk rating remote
audits are preferred
method
In case of low risk
rating desktop and or
virtual audits are
preferred method
On-Site
Audi
-tor
Risk
Level
Performance Rating
Poor
Critical
Moderate
Minor
Medium
Low
Low
High
Medium
Low
High
High
Medium
Good Moderate
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25. Classification: Public
Regulatory view – BioPhorum guidance
Source
https://www.biophorum.com/download/peer-to-peer-practical-guidance-on-remote-inspections-and-audits/#
Positive experience on remote & virtual audits
Risk based approach can influence audit type
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26. Classification: Public
Multi site audit – Hybrid approach
❖ Most effective for auditor but high effort for auditee
❖ Audit of multi site production is possible
❖ Only one travel for auditor
❖ Flexible to time zones
1st Day 2nd Day 3rd Day
On-Site
Desktop
&
Virtual
Remote
✓ Digital document
review
✓ US site virtual tour
✓ Virtual SME
contact
✓ On-Site tour at
European site
✓ On-Site SME
contact
✓ Asia site remote
tour
✓ On-Site SME
contact from
Europe
✓ Virtual SME from
Asia
Audi
-tor
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27. Classification: Public
Multi site audit – Hybrid risk based approach
1st Day – Low Risk 2nd Day - High Risk 3rd Day – Medium Risk
On-Site
Desktop
&
Virtual
Remote
✓ Digital document
review
✓ Virtual SME
contact
✓ On-Site tour
✓ On-Site SME
contact
✓ Remote site tour
✓ Remote SME
contact
Audi
-tor
❖ All risk level will be covered
❖ Effort and time consumption can be leveraged
according to risk
❖ Higher flexibility in risk management
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28. Classification: Public
1st, 2nd, 3rd – Party audits
1st 2nd 3rd
Internal Audit
The auditor is employee within
the same company where the
audit will be executed
Supplier Audit
The auditor is employee of an
external supplier and is auditing
another company
3rd Party Audit
The auditor is from an
independent certification body or
regular authority and will audit a
company
SME
Audi
-tor
SME
Audi
-tor
SME
Audi
-tor
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29. Classification: Public
Hybrid approach can be used for
System
Accordance to a
Management System e.g.
ISO 9001
Qualification
Qualification of a
product, supplier, site, …
Process
Verification of processes
Project
Review of project
progress
Product
Verification of a product
or products
Compliance
Verification of conformity
with a set of rules
1
2
3
4
5
6
Using hybrid
approach
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30. Classification: Public
Audit tendencies
▪ High priority request
▪ Review of particular
Quality System
▪ Specific concerns
Audit for cause
Hybrid approach
▪ Audits on regular
basis
▪ By customers or
authorities
▪ Quality system
requirements
Routine or Surveillance
audit
Hybrid approach
▪ Qualification of sites
▪ Qualification of new
products
Qualification audit
On-Site preferred
Digital tools can
assist
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31. Classification: Public
Regulatory – FDA Dashboard
Source
https://datadashboard.fda.gov/ora/cd/inspections.htm
Covid-19
▪ What do we expect
• Audit activity will increase
rapidly after pandemic
• Digital tools will help to
increase audit activity
• Increasing audit activity is
expected by us due
regulatory requirements
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32. Classification: Public
Benefit of digital audit solutions
Save time money for auditors travel cost
and time.
Higher flexibility according to audit
frequency applying risk-based approach.
Better audit preparation and execution
by using hybrid approach.
Time flexibility to different time zone
and or split audit agenda.
No travel / access restriction.
Be compliant & sustainable
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33. Classification: Public
Look into the future
Risk-Based Audit
Planning will enable
the industry to be
more agile
Digital solutions will
not entirely replace
the need for On-Site
audits
Remote and Virtual
audits will be a solid
part of inspections
Hybrid audits are
the future
Joint audits will
continue to increase
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34. Classification: Public
Thank you for your attention
If you have any questions, please do not
hesitate to reach out.
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35. Classification: Public
daniel.buescher@emdgroup.com
Daniel Buescher
The vibrant M and M Lab are a trademark of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed
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