Version Description of Changes

1.0 New protocol as per PR 150667

 TABLE OF CONTENTS
1. PURPOSE
2. OVERVIEW
3. DEFINITIONS
4. PROCESS & ACTION APPROVALS
5. CONCLUSION
6. REVISION HISTORY
7. LIST OF APPENDICES
1. Purpose

The purpose of this Document is to provide a summary of the SAP movement,

receipt, control and release of the following SKU 200433 RAVULIZUMAB
10MG/ML BDS PORRINO at AAMF batch number 1069311.

2. Overview
RAVULIZUMAB 10MG/ML BDS PORRINO is a sterile clear, colourless,
preservative-free solution for intravenous infusion and is supplied in 30m ml glass
vials. The manufacturing process consists of drug substance pooling, bioburden
reduction filtration, transfer, sterile filtration, filling, stoppering, capping and visual
inspection. The bulk Drug substance is supplied, as a low bioburden liquid product in
100L Hyclone Bioprocess Bags, at a concentration of 10mg/ml. It is stored at 2-8°C.
The BDS bags are stored in the 2-8°C coldroom. Each BDS bag is placed in a plastic
drum to protect from light. All BDS batches are accompanied by the supplier’s
relevant documentation, together with CoA and temptale data that are all reviewed as
part of the release process. Tailgates samples are provided with the BDS Bags and
these are used for identification testing that is performed at ADMF.

BDS Batch 1069311 SKU 200384 ALXN1210 10mg Lonza Porrino was
manufactured at Lonza Biologics Porrino (LBP), S.L. C/La relba, s/n. Porrino,
Pontevedra, 36400, Spain. The previous listed are currently in AAMF and are fully
released. All batches are nearing expiry. There is a requirement to convert Clinical
ALXN1210 10mg/ml BDS (Product Number 200384) into commercial BDS batches
(Product Number 200433) to enable the filling of Ultomiris drug product batch
230413 using this BDS batch.
Batch 1069311 bag 5 and 6, total quantity 375.4Kg, are intended to be used in
RAVULIZUMAB DP 10mg SKU 200349 commercial manufacturing at Alexion
Athlone Manufacturing Facility (AAMF).

Change Control PR150667 Use of Clinical BDS Lot 1069311 SKU 200384
ALXN1210 10mg Lonza Porrino in RAVULIZUMAB DP 10mg SKU 200349
commercial manufacturing at Alexion Athlone Manufacturing Facility (AAMF).

Table 1: Lots and quantities impacted

Current Clincal Alexion Batch Proposed Lot size to be

Product Number converted &
Number commercial Product
released
number

200348 1069311 200433 375.4kg

3. Definitions

AAMF Alexion Athlone Manufacturing Facility

ADMF Alexion Dublin Manufacturing Facility
BDS Bulk Drug Substance
COA Certificate of Analysis
CC Change Control
Kg Kilogram
MSR Material Specification Report

4. Procedure

Steps required to be performed as detailed in appendix 1.

Any issues encountered during the execution of these steps should be escalated to QA
on identification.
 1. List of Appendices
 Appendix 01 Executed Inspection and Release Requirements for
SKU 200433 RAVULIZUMAB 10MG/ML BDS PORRINO batch 1069311

Appendix No: 1

Document Title
Executed Inspection and Release Requirements for
SKU 200433 RAVULIZUMAB 10MG/ML BDS PORRINO batch
1069311

Material Number 200433

Batch Number 1069311

Performed By: Steps Signature Date

Warehouse Reference PR150667 on Clinical
completed MSR
Warehouse Confirm executed MSR for
commercial batches is completed –
Attach as attachment 01 to this
appendix.
Warehouse Confirm bag numbers and quantity in
each bag in table 1 below
Warehouse Record SKU 200433
RAVULIZUMAB 10MG/ML BDS
PORRINO batch 1069311 in the
logbook ALXN-FRM-0006213 as
per ALXN-SOP-0004239 General
Operation and Local Alarm Handling
of AAMF Cold Rooms and reference
PR150667
Warehouse Print new SAP label containing
product number for commercial BDS
(SAP SKU 200433)
Quality Verify the correct product number
Assurance (SAP SKU 200433) on the printed
label prior to application
Performed By: Steps Signature Date
Warehouse Apply new label to drum
Warehouse Deface existing label by striking one
line through and initial and date.
Quality Verify the application of new label
Assurance and defacement of existing label
Warehouse Take photograph on both labels and
attach to this appendix as attachment
02
Warehouse Move BDS back to rack location

Verified by:
Confirm attachments 01 and 02 are attached Completed: Yes No
Initial/date:

Table 1:

Bag Number Quantity

Quality Review and Release for Further Processing

Performed by: Steps Signature Date

Complete Trackwise search of
batch tagged deviations and
change controls. Commercial and
Clinical BDS Product Numbers
200433 & 200384. Attach
Quality searches to this appendix as
Assurance attachment 03.
Confirm compliance to enable
RFFP
Meets requirements
Does not meet requirements
Verify the executed MSR is
Quality attached (Attachment 01) and the
Assurance batch is fully released for
commercial product number.
 Release batch for further
processing on SAP.
Quality SAP UD Decision:
Assurance
Performed by:
Date Performed:
Confirm attachment 03 is attached Completed: Yes No
Initial/date:

Certificate of Analysis Review

Name Steps Signature Date

Review of CoA against DS
Specification for material
number 200433 and confirm
acceptance criteria is met.
Quality Control Attach CoA to this appendix as
attachment 04.
Meets requirements
Does not meet requirements

Completed: Yes No
Confirm attachment 04 is attached
Initial/date:
Full Release

Name Steps Signature Date

Complete Trackwise search of
batch tagged deviations and
change controls for Commercial
Quality and Clinical BDS Product
Numbers 200433 & 200384
Assurance Attach searches to this appendix
as attachment 05.
Meets requirements
Does not meet requirements
Review QA External pack confirm
Quality full release decision.
Assurance Attach pack to this appendix as
attachment 06.
Release batch on SAP.
Quality SAP UD Decision:
Assurance Performed by:
Date Performed:
Completed: Yes No
Confirm attachment 05 and 06 is attached
Initial/date:

List of Attachments:

Attachment 01 Executed ALXN-FRM-0006991.

Attachment 02 Photographs of new label applied to all drums
Attachment 03 Trackwise search for batch tagged deviations and change controls.
Attachment 04 Certificate of Analysis for BDS (Product Number 200433)
Attachment 05 Trackwise search for batch tagged deviations and change controls.
for both the Commercial and Clinical BDS Product Numbers
200433 & 200384
Attachment 06 External QA Full Release Pack