Doc #: ALXN-QD-0012543

Version: 2.4 Status: In Coordination

DocuSign Envelope ID: 32C4BF3E-5A39-4816-B9D1-97BD965E76FB
ALXN-QD-0012543 Appendix 3 'Changes' for ALXN-QD-0012421

Quality Agreement between Alexion Pharma International

Operations Limited and SGS Canada and SGS North America
for Testing Services
ALXN-QD-0012543 V3.0: Appendix 3 of ALXN-QD-0012421
Changes

Examples of changes that must be notified:

Change Type Example of Change Notification Notification not
required required
Laboratory/Methods Changes to laboratory equipment with X
potential quality or regulatory impact

on
Changes to laboratory equipment with no X
potential quality or regulatory impact
Changes to analytical methods or method of X
sampling that are related to Alexion

ati
products
Change in Test specifications X
Changes to testing laboratory (e.g. company, X
location)
din
Administrative Changes in company name or address (prior X
Changes notification but ALEXION approval not
required)
Change of site name or address (prior X
notification, but Alexion approval not
or

required)
Change in location of laboratory (even at the X
same site)
Co

Version History

Change Type
Version (New, Revise or Revision Summary Justification
Number
Admin)
In

Vault document number included

Signature section expanded to allow for e-signatures
2.0 Revise QAG periodic review
Alexion key contacts updated
Included signature space for SGS Lincolnshire

Updated Alexion entity name on header.

Updated Administrative change: Change in location of
3.0 Admin QAG periodic review
laboratory (additional wording added to complete the
sentence)

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ALEXION CONFIDENTIAL
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Alexion Confidential | Page 1 of 2
 Doc #: ALXN-QD-0012543Version: 2.4 Status: In Coordination
DocuSign Envelope ID: 32C4BF3E-5A39-4816-B9D1-97BD965E76FB
ALXN-QD-0012543 Appendix 3 'Changes' for ALXN-QD-0012421

Quality Agreement between Alexion Pharma International

Operations Limited and SGS Canada and SGS North America
for Testing Services
ALXN-QD-0012543 V3.0: Appendix 3 of ALXN-QD-0012421
Changes

Contract Giver
Name Position Signature Date

on
Senior Manager, 21-Apr-2023 | 05:46:08 EDT
Petrina Donaghy
External Quality Control

ati
Name Position din Signature Date

Executive Director, 25-Apr-2023 | 06:41:04 EDT

Jane Wyatt
Quality Operations

Contract Acceptor
Name Position Signature Date
or

Quality Assurance 10-Apr-2023

Behsheed Akhavan
Co

Manager (Mississauga)

Name Position Signature Date

In

Quality Assurance 12-Apr-2023

Fredrick Okech
Manager (West Chester)

Name Position Signature Date

Nichole James Quality Assurance 10-Apr-2023

Manager (Lincolnshire)

Legal Reviewed

DN

Page 2 of 2
ALEXION CONFIDENTIAL
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Alexion Confidential | Page 2 of 2