SOP Managing Recalls

GSK VQD-SOP-016604 v: 2.
0 Retrieved: 05 Apr 2023 Effective: 30 Sep 2022

SOP Managing Recalls
SOP
VQD-SOP-16604 Managing Recalls
Quality BeNeLux
Authentification
Name Function
acting Quality Head BeNeLux /

Author Stan Tinnemans
Responsible Person
Quality Executive LOC NL / Responsible

Jason Fagg
Reviewer Person
Quality Lead BeLux / Responsible

Approver Gordana Brajanoski
e Person
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Proprietary Information. Do not disclose without consent.

The current version from Veeva QualityDocs must be used. Page 1 of 24.
GSK VQD-SOP-016604 v: 2.0 Retrieved: 05 Apr 2023 Effective: 30 Sep 2022
SOP
Quality BeNeLux
Contents
1 PURPOSE ..................................................................................................................... 3
2 SCOPE .......................................................................................................................... 3
3 RESPONSIBILITIES ..................................................................................................... 4
4 INSTRUCTIONS ............................................................................................................ 6
4.1 Seek Approval from the Impacted Regulatory Authorities ................................. 7
4.2 Appoint a Recall Coordinator ............................................................................... 7
4.3 Initiate the Recall ................................................................................................... 8
4.4
4.5 e
Perform the Recall ................................................................................................. 8
Document a Summary of the Recall ..................................................................... 9
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4.6 Close the Recall................................................................................................... 11
4.7 Perform Product Incident and Recall Simulations ............................................ 12
4.8 Perform an Effectiveness Check ........................................................................ 13
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5 REFERENCES ............................................................................................................ 13
6 GLOSSARY ................................................................................................................ 13
7 REVIEW AND REVISION ........................................................................................... 15
8 CONTINGENCIES ....................................................................................................... 15
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9 HISTORY OF CHANGE .............................................................................................. 15

APPENDIX 1 CLASSIFICATION OF HEALTH HAZARDS AND LEVEL OF EXTERNAL
RECALL.............................................................................................................................. 16
APPENDIX 2 CONTACT DETAILS DUTCH AUTHORITIES .............................................. 17
APPENDIX 3 BEST PRACTICES FOR HANDLING RECALLS ON PATIENT LEVEL IN THE
NETHERLANDS ................................................................................................................. 18
APPENDIX 4 BEST PRACTICES FOR BELGIUM.............................................................. 21

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1 PURPOSE
To define a systematic, standardised, risk-based approach for managing recalls to ensure
patient safety, product quality, efficacy / performance and regulatory compliance.
2 SCOPE
This procedure is also applicable to the Belgium/Luxembourg LOC and to products related
to ViiV Healthcare.
This procedure covers the management of recalls, within Pharma Supply Chain (PSC),
initiated by GSK or regulatory authorities from:
 the internal GSK distribution chain
 wholesalers
 hospitals
 pharmacies and surgeries
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 retail outlets
 patients
It applies to internal and external recalls of:
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 medicinal products, including intermediate and bulk product

 Active Pharmaceutical Ingredients (APIs) and API intermediates
 investigational medicinal products
 commercial product used for comparator clinical trial studies
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 medical devices
 promotional stock, demonstration samples, medical samples, registration samples
It applies to third party Marketing Authorisation Holder (MAH) recalls where GSK is
responsible for an element of recall execution. However, the relevant quality agreement
must be consulted to determine which steps in the process must be performed by GSK.
It does not apply to the commercial market withdrawal of a product from the internal or
external distribution chain for commercial reasons, for example stock rotation, application
withdrawal, which is not related to a quality defect, product incident or recall.
This procedure starts once the Global Recall Board (GRB) have approved the recall.

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3 RESPONSIBILITIES
Role Key Responsibilities
Product Incident  Seeking approval for the recall from regulatory authorities, where
Chair required
 Appointing a recall coordinator
 Initiating the recall
 Providing periodic updates to regulatory authorities, as required
 Managing recalled product in accordance with the recall strategy
 Performing a risk assessment, with the Recall Coordinator, if the
recall is assessed as ineffective

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Performing an AAR on the recall
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 Retaining all primary documentation associated with the recall
 Closing the recall in PRS
Recall Coordinator  Performing batch tracing activities, if not already performed

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 Monitoring the progress of the recall

 Providing interim status updates in PRS
 Documenting a summary of the recall
 Performing a reconciliation of the recalled product
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 Performing an effectiveness check on the recall

 Performing a risk assessment, with the Product Incident Chair, if the
recall is assessed as ineffective
 Collating all documentation related to the recall
 Submitting the recall for closure in PRS
Quality (i.e. LOC  Managing and putting recalled product on hold

Quality Head /
Responsible Person)  Amending and documenting the batch disposition for recalled batches
 Performing product incident and recall simulations
 Performing effectiveness checks of the product incident and recall
process
 Overall accountable for Recall process in the LOC
 Ensuring the process is in-place and in-use for QMS activities
according to local legislation requirements / GDP
 Use Appendix 2-4 in this SOP to comply with local requirements for NL
and BE

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GRB  Reviewing and, where required, approving changes to the recall in

PRS
Regulatory  Supporting the distribution of communication material, as required
General Manager  Accountable for ensuring the full deployment of this SOP
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4 INSTRUCTIONS
Process Flow
Start
4.1 Seek Approval from

the Impacted Regulatory
Authorities
4.2 Appoint a Recall

Coordinator
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4.3 Initiate the Recall
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4.4 Perform the Recall
4.5 Document a Summary

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of the Recall
4.6 Close the Recall
End
4.7 Perform Product

Incident and Recall
Simulations
4.8 Perform an
Effectiveness Check

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Step Instruction Responsible

No.
4.1 Seek Approval from the Impacted Regulatory Authorities

Once the Global Recall Board (GRB) have approved the recommendation to recall, the Product
Incident and Recall System (PRS) will generate a recall record with a unique number. The recall
number must be used on all documentation associated with the recall.
Where required, a recall must also be raised in the local quality system.
Where appropriate, approval must then be sought from the impacted regulatory authorities.
Under exceptional circumstances, and in the event of an urgent life-threatening safety issue, the
recall and communication with the regulatory authorities can occur at the same time if local
regulations allow it.
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4.1.1 Where required by local regulations, contact the impacted regulatory Product
authorities and seek approval for the recall. Incident Chair
or delegate
Provide the communication materials created during the PIRC and any
other documentation required by the market.
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Determine if any other regulatory authorities need to be notified, for

example the local and / or supervisory regulatory authority.
If so, notify in accordance with the product incident communication
plan.
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4.1.2 If the regulatory authority approves the proposal to recall, or where Product
regulatory authority approval is not required, go to Step 4.2. Incident Chair
or delegate
If the regulatory authority decides that a recall is not required:
 work with the regulatory authority to determine the required
course of action
 assess if further product incident committee meetings are
needed
 notify the GRB of the recall cancellation in PRS to inform them
of a change to the original recommendation
 update the product incident meeting minutes and the
associated product incident record in PRS, where required
4.2 Appoint a Recall Coordinator

The recall coordinator is responsible for the coordination of the operational elements of the recall
and must have the appropriate experience and skills to perform the role.
4.2.1 Appoint a recall coordinator and enter their name into the recall record Product
in PRS. Incident Chair
Where multiple sites and / or markets are impacted, consider

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appointing local recall coordinators.
4.3 Initiate the Recall

A recall notification is used to cascade information about the recall to interested parties within
GSK.
The recall notification is issued from PRS and emailed to a defined distribution list.
4.3.1 Using PRS, create and issue a recall notification. Product

Incident Chair
Ensure that the level of detail of the recall notification aligns with any
or delegate
regulatory communications.
4.3.2 If not already completed, perform batch tracing activities to identify and Recall
locate all impacted product. Coordinator or
delegate
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Ensure that all remaining product at GSK sites and companies and / or Product
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4.3.3
distributors is on hold. Incident Chair
or delegate
4.3.4 Distribute the recall communication materials in accordance with the Product
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communication plan developed during the PIRC. Incident Chair

or delegate
4.3.5 Inform all indirectly impacted markets, where required, of the recall. Product
Incident Chair
or delegate
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4.3.6 For serialised products, communicate the decommissioning strategy to Product

all relevant parties, including the Serialisation Service Incident Chair
([email protected]). or delegate
4.3.7 If the scope of the recall changes, for example a change to the level or Product
class of the recall (see Appendix 1), to the impacted product(s), or to Incident Chair
the number of batches or markets involved, amend the recall record in or delegate
PRS.
4.3.8 For change requests to the class or level of a recall: GRB

 review and assess the change, and
 approve or reject the request in PRS
For changes to the impacted product(s), number of batches or markets
in a recall, review the change in PRS.
4.4 Perform the Recall

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4.4.1 Monitor the progress of the recall in all impacted markets. Recall
Coordinator
4.4.2 Send follow up communications, as required, to direct accounts / Recall

customers that have failed to respond to the initial recall Coordinator or
communication. delegate
4.4.3 Provide interim status updates in PRS as the recall progresses. Recall
Coordinator
4.4.4 Provide periodic updates on the progress of the recall to regulatory Product
authorities, as required. Incident Chair
or delegate
4.4.5 Manage and put on hold all recalled product according to the local Quality
warehouse management procedure.
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4.4.6 Manage the recalled product in accordance with the recall strategy, for Product
example arrange for the destruction of the product, rework internally Incident Chair
recalled product. or delegate
Retain the certificates of destruction or rework documentation.
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4.4.7 Confirm that any required decommissioning of the impacted packs has Product
been performed in accordance with the decommissioning strategy. Incident Chair
or delegate
Retain the evidence of decommissioning.
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4.5 Document a Summary of the Recall

The Recall Summary Report Template must be used to document the overall summary of the
recall.
Alternatives to the reconciliation record in the recall summary report can be used. Where this is
the case, attach the reconciliation results to the recall summary report and add a comment.
4.5.1 Using the Recall Summary Report Template, document: Recall

Coordinator
 the recall number
 the product name(s)
 an executive summary of the recall
 the recall type, class and level
 the number of batches impacted (external / internal / third party)
 the impacted batch numbers
 the impacted markets
4.5.2 Using the Recall Summary Report Template, perform and document Recall
the reconciliation, including an effectiveness check, of the recalled Coordinator

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product for each impacted market.

In determining if the recall has been effective, consider factors such as
the:
 number of packs in scope of the recall
 number of packs returned
 level of recall
 stock usage in the market
 time the product has been on the market
 shelf life of the product
 patient use of the product, for example is the product used daily
 prescribing pattern of the product, for example the dispensing
of multiple units
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4.5.3 Using the Recall Summary Report Template, perform and document Recall
an overall effectiveness check for the recall. Coordinator
4.5.4 If the recall is assessed as ineffective, perform a risk assessment. Product

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Incident Chair
and Recall
Coordinator
4.5.5 If an unacceptable level of risk is identified for any product that cannot Product
be located and / or retrieved, take appropriate action, for example Incident Chair
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reconvene the product incident committee, communicate with or delegate

regulatory authorities.
4.5.6 Collate all documentation relating to the recall, including, where Recall
applicable: Coordinator
 reconciliation records
 recalled product certificates of destruction
 evidence of decommissioning
 rework documentation, including reconciliation
4.5.7 Amend and document the batch disposition for all recalled batches by: Quality
 retrieving and updating batch records
 assigning the appropriate batch status in any relevant
electronic system
4.5.8 Using the Recall After Action Review Template, perform and document Product
an AAR on the recall. Incident Chair
or delegate

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4.5.9 Using the Recall Summary Report Template, determine whether the Recall
recall closure criteria have been met: Coordinator
 All identified product has been recovered from the GSK
distribution chain (internal recall)
 It is unlikely that any further stock will be returned from the
market (external recall)
 The impacted stock has been returned or destroyed, in
accordance with the recall strategy (internal and external recall)
 Where stock has been destroyed, the certificates of destruction
have been received (internal and external recall)
 Where rework has been performed, the rework documentation,
including reconciliation, has been received (internal recall)

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Where decommissioning has been performed, the evidence of
decommissioning has been received (internal and external
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recall)
 The batch records and batch status in any relevant electronic
system have been updated with the disposition for all recalled
batches (internal and external recall)
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 There is no outstanding regulatory activity and, if applicable, the

regulatory authority has issued a formal closure letter (internal
and external recall)
 There is no ongoing press activity or interest (external recall)
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 Any telephone enquiry mechanisms have been discontinued

(external recall)
 The effectiveness has been documented for each impacted
market (external recall) and the overall recall (internal and
external recall)
 An AAR of the recall operation has been completed (internal
and external recall)
If the criteria have been met, progress the recall for closure.
If not, continue to monitor the recall until the closure criteria have been
met.
4.6 Close the Recall
4.6.1 Approve the recall summary report and upload a copy of it and all Recall
associated documentation into PRS, including, where applicable: Coordinator
 recall communication with regulatory authorities, including any
periodic regulatory updates

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 regulatory authority recall closure letters

 reconciliation records
 recalled product certificates of destruction
 evidence of decommissioning
 rework documentation
 recall AAR
Submit the recall record for closure in PRS.
4.6.2 Retain all primary documentation in a suitable local documentation Product

repository. Incident Chair
or delegate
Retain all documentation in accordance with POL-GSK-506 or local
requirements, if longer.
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When assigning the GRS, consider the retention requirements of all
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impacted products and assign the GRS with the longest retention
period.
Ensure that the product incident and recall documentation retention
periods are aligned.
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Manage all recall documentation as critical and sensitive information.
4.6.3 Review the recall record in PRS and check that: Product
Incident Chair
 it has been completed correctly

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the appropriate retention period has been selected

 copies of the recall summary report and all associated
documentation have been uploaded
 the location of primary records is recorded
Once complete, approve and close the recall record.
4.6.4 Close the recall in the local quality system, as required. Product
Incident Chair
or delegate
4.7 Perform Product Incident and Recall Simulations

Product incident and recall simulations are required to ensure the procedures and process are
robust and fit for use.
4.7.1 Follow the procedure for managing product incidents and perform a Quality
product incident and recall simulation.

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4.8 Perform an Effectiveness Check
4.8.1 Follow the procedure for managing product incidents and perform an Quality
annual effectiveness check of the product incident and recall process.
5 REFERENCES
Parent document – PGSOP 028 Managing Recalls v 1.0
Reference No. Reference Description
GQP 8205 Management of Product Incidents and Recalls
POL-GSK-506 e
Policy on Global Records Retention
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Global Records Retention Policy
POL-GSK-506
http://recordsretention.gsk.com/retweb/default.asp
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6 GLOSSARY
Term Description
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Directly Impacted A market that has received product impacted by the product incident.
Market
External Distribution Storage and distribution of product no longer owned by GSK.

Chain
External Recall The process of recovering product no longer owned by a GSK Entity from
the external distribution chain, due to a product incident.
Indirectly Impacted A market where the regulator requires formal notification of product
Market incidents for products registered in the market, even if they have not
received the impacted batches.
Internal Distribution Storage and distribution of product owned by GSK, includes sites, LOCs
Chain and third parties that are under contract for GSK, for example Local
Service Providers, multi-market warehouses.
Internal Recall The process of recovering product:

 which is related to a product incident
 is beyond the final quality assurance release step of the finished
product by the manufacturing site, and

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 is in the internal distribution chain (is owned by GSK)
Internal Recall Boundary
Manufacturing Product
LOC QA
Site Final QA Owned by
Release Step
Release Step GSK
OUT of scope of this definition are quality issues introduced during a

routine LOC activity found before LOC QA release. For example, routine
addition of market specific leaflet.
Product
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A generic term to describe an API, intermediate, bulk or finished product.
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Product Incident Suspected or confirmed product related incidents that potentially affect
quality, safety, efficacy / performance, compliance with regulatory
standards, product specific registered details, or clinical trial registered
details, and the product is beyond the final quality assurance release step
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by the manufacturing site.
Product Incident and A GSK IT platform used to record and track product incidents and recalls.
Recall System
(PRS)
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7 REVIEW AND REVISION

This SOP will be reviewed periodically (at least every 3 years) and updated, if required.
8 CONTINGENCIES
Adherence to the requirements of an SOP is mandatory. Under certain circumstances an
exemption from the requirements of an SOP may be permitted.
When an individual activity needs to deviate from the requirements of an SOP for
compelling business reasons, written authorization of this deviation is obtained, in advance,
from the SOP approver(s) of the affected functional area and documented in a file note.
For QA related procedures, a planned deviation from a SOP is to be in the QMS (e.g.
Veeva QMS) as a temporary Change Control.
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9 HISTORY OF CHANGE
Effective Date
Version
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Changes
Adoption of PGSOP 028 Managing Recalls into local documentation system.
1.0
Added Appendix 2-4 to include local requirements for BE end NL.
This SOP replaces the SOP 8.001 SOP Management of Product Incidents and
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recalls.
This SOP replaces the BeLux SOP SOP GSK B 6048 Product Incidents and
recalls.
Update of Lay-out due to VQD implementation.
2
Update of Appendix 3 (NL specific details): Change LSP Alloga to
EuroTransPharma/Movianto (CC 1475833)

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APPENDIX 1 CLASSIFICATION OF HEALTH HAZARDS AND LEVEL OF EXTERNAL

RECALL
Class and Level of local regulations must be applied for impacted markets.
FDA Classifications:
 Class I – a situation in which there is a reasonable probability that the use of, or
exposure to, a violative product will cause serious adverse health consequences or
death.
 Class II – a situation in which use of, or exposure to, a violative product may cause
temporary or medically reversible adverse health consequences or where the probability
of serious adverse health consequence is remote.
 Class III – a situation in which use of, or exposure to, a violative product is not likely to
cause adverse health consequences.
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EU Classifications:
 Class 1 – the defect is potentially life-threatening or could cause serious risk to health.
 Class 2 – the defect could cause illness, mistreatment or harm but is not life-threatening
or serious.
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 Class 3 – the defect is unlikely to cause harm to the patient, and the recall is carried out
for other reasons, such as non-compliance with the marketing authorisation or
specification, and is not Class 1 or 2.
Level of Recall from the Distribution Chain:
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 Level 1 – Consumer or user level, which may vary with product, including any
intermediate wholesale or retail level.
 Level 2 – Retail level, all distribution facilities, hospitals, pharmacies, retail outlets,
including any intermediate wholesale level.
 Level 3 – Wholesale level.

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APPENDIX 2 CONTACT DETAILS DUTCH AUTHORITIES

The Health and Youth Care Inspectorate (IGJ) must be contacted in case of quality defects to
medicinal products. Contact with IGJ must only take place via the PQM or delegate. Contact
details of IGJ are available on their website www.IGJ.nl.
It is required to submit the recall communication for the approval of IGJ. Once the recall
communication is approved, VIG (www.vereniginginnovatievegeneesmiddelen.nl) can be
contacted to initiate the recall and perform necessary actions as per local regulations.
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APPENDIX 3 BEST PRACTICES FOR HANDLING RECALLS ON PATIENT LEVEL IN

THE NETHERLANDS
Involvement within LOC NL
An issue with the product quality can lead to a Local Incident Committee (LIC). As soon
as a LIC-meeting has been created following the current procedure LSOP for
Management of Product Incidents (VQD-SOP-016603), the LIC will start the local
preparations. All departments that will have a role in the recall should attend the LIC
and also the related management team members. The aim of the LIC is that all involved
departments will have the same starting point in the recall process. Also to be sure that
all needed departments will understand the urge and impact of the recall.
In case of a recall it is very important to involve commercial operations as well as the

communication department in the LIC. Pharmacists may request reimbursement of the
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recall costs by GSK. Therefore it is advisable to decide on a reimbursement strategy
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early during the LIC-process and to involve the communication department in the LIC.
Involvement of the authority

LOC QA informs the Dutch Inspectorate (IGJ) on the quality defect and on the
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proposed market actions. The IGJ approves the recall based on the risk to public
health. The classification triggers the level of recall. There are three levels of recalls:
- Patient level (level 1)
- Pharmacist level (level 2)
- Wholesaler level (level 3)
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A recall is always excecuted by the Marketing Authorisation Holder (MAH).

In case the IGJ considers a recall, IGJ will always discuss this with the MAH first. Vice
versa, an MAH may only excecute a recall after approval from the IGJ.
Communication to the wholesalers

In case of a recall at level 1, 2 or 3, wholesalers should block the recalled product as
soon as possible in their system. The LOC QA department of GSK should give the
order to wholesalers to block the stock of the recalled product via e-mail. For a quick
effect, it is advisable that customer service or LOC QA contacts all wholesalers by
phone as well. Because the blocking request is usually earlier than the approval by IGJ
and sending out of the recall letter, the wholesalers may ask the reason for the blocking
request. In that case it can be mentioned that it concerns a potential recall and that the
investigation is ongoing.
Furthermore LSP Eurotranspharma/Movianto (Oss) should be informed through Yusen

on the fact that recalled products will be returned to Movianto. Customer Service is
responsible for the return process.

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Make sure to inform wholesalers first about the recall and not at the same time as the
rest of the market (pharmacists and patients), because wholesalers need to be
prepared for the returning process.
Communication to the market

A recall letter should be sent in special envelopes, the so-called ‘Orange Hand-
envelopes’ or ‘Oranje Hand-enveloppen’. These envelopes are only used in case of a
recall of a medicinal product. Therefore these envelopes have special attention of the
pharmacists.
Orange Hand-envelopes are available at the Vereniging Innovatieve Geneesmiddelen
(VIG). Envelopes can be ordered by sending an e-mail to
[email protected] or call 070-3132222. More information can be
found on the website of the VIG www.vereniginginnovatievegeneesmiddelen.nl.
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The content of the letter is in agreement with MAH, CBG and IGJ. However, the VIG
requests to share the letter and approval of IGJ when ordering the envelopes.
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In order to be prepared by GSK on incoming calls, it is advisable to prepare a Q&A
document by the communication department for customer facing roles.
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Recall letter
The IGJ has a template for recall letters. It is advisable, in case of a recall at patient
level, to add an example of the patient letter to the recall letter in the envelop. This will
support pharmacists in sending out a high volume of patient letters. If a picture of the
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product is presented in the patient letter, make sure the batch number is not readable
or the batch number is identical to the recalled batch. Otherwise this can lead to
confusion of the patient. Some pharmacists may request GSK to send the recall letter
with patient letter digitally. This can be done, but it is important to agree in the LIC who
is handling these requests within the LOC.
In case a communication pack is provided by the PIRC, a translation should be made in

the LOC. The responsibility of the translation needs to be agreed in the LIC-meeting.
The template for recall letters of the IGJ needs to be considered.
Publication
Any recall in the Netherlands will be published on the website of the KNMP and IGJ.
For the duration of 5 years, all recalls on the Dutch market will be mentioned on the
website of the CBG and in the CBG Geneesmiddeleninformatiebank. Based on the
classification of patient risk, IGJ can decide to inform other Inspectorates as well trough
the rapid alert system.
Returns

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After sending out the recall letter, patients will start to return the impacted product to the
pharmacy. The pharmacies then will send the returned products back to their
wholesalers. LSP EuroTranspharma/Movianto should be instructed to pick up the
recalled products from the wholesalers. LSP EuroTranspharma/Movianto will then
quarantaine all returned products for the reconciliation as per the returns process,
(VQD-SOP-016645).
Reimbursement
It is advisable to decide on a reimbursement strategy early in the LIC process, because
pharmacists may request reimbursement of the recall costs in case of a level 1 or 2
recall. However, the reimbursement of the costs is not mandatory. The reimbursement
policy of that specific recall should also be communicated to the customer facing roles.
It is preferable to add the information on the (potential) reimbursement in the recall
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letter. If this is not possible, then it is advisable to add this information as fast as
possible in the Q&A document.
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APPENDIX 4 BEST PRACTICES FOR BELGIUM

Belgian and Luxembourg specificities for External Product Recall :
 Before initiating any recall, inform the Belgian and Luxembourg authorities. Provide
the reason of the recall and any relevant description of the issue resulting in the
recall.
Belgium : Brasseur Severine [email protected] or usual inspector
Luxembourg : MS Défaut Qualités Médicaments [email protected] + Anna

Chioti [email protected] in copy
 Assess if the recalled batch has also been distributed as a medical samples.
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If yes, then contact the third party distributor to initiate the recall following the
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process in place.
External Recall performed through APB (Association Pharmaceutique Belge):
Go on APB website :
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 open ‘’liste de retrait’’, you will see the screen below:

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 open the electronic form under the tab ‘’Téléchargez ici le formulaire de demande
de retraits’’
 complete the information required, including the reason of the recall
 always specify the following information regarding the reimbursement via APB +
Price to be reimbursed as well as the destruction to be done by the APB

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Note: APB will only credit private Pharmacies, GSK still have to credit the wholesalers
and hospitals.
 Print and sign off the form and send it to the APB using the address :
[email protected]
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 The APB will generate the recall notification and send it to GSK for review before
publication.
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 Once approved by GSK, the recall notification will be published within 24h on the
APB website then published in the ‘’Nouvelles Brèves/ Korte Berichten
 All products from ALL distribution channels should be sent to APB for counting and
storage for destruction.
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 At recall closure, APB will send an overview list of all products returned, quantities
and customers who have returned the products.
 Request a destruction certificate when the destruction has been completed by the
APB.
Note 1: the recall via APB covers also all distribution channels in the Luxembourg and
Ef
same process is applied
Note 2: Patient level recall must always be discussed and agreed with the authority
before to initiated.
External Recall performed manually by GSK:
This type of recall can only be organized if it is not possible to do it through APB and if all
end users (not at patient level), delivered quantities and batch numbers can be clearly
retrieved from CERPS recall lists. e.g delivery only to hospitals or tenders communities.
Following process should be followed:
 Retrieve recall list for every impacted batch from CERPS

 Collect the name and delivery addresses, and if possible e-mail addresses and/or
fax and telephone numbers.
 Complete the appropriate communication form with the impacted batch data,
reason of the recall, recovery instructions and ultimate return due date. If required,
include also any additional medical communication elaborated and approved by
medical department.

SOP
Quality BeNeLux
 Prepare a mailing using the regular mail; specify a delivery within 1 working day.
Where possible use also e-mailing for faster delivery.
 Agree with Customer Service to arrange the Pick-up of the recalled product at the
customer and bring them back to local warehouse for destruction (e.g. Movianto)
 Perform regular follow-up and reconciliation check on returned product and provide
regular update to the Regulatory authorities if requested.
 When the ultimate recall due date is reached and the destruction of the recalled
product have been completed by the local warehouse, request the final return list
and destruction certificate then perform recall reconciliation and closure.
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tiv
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Document Approvals by Electronic Signature
Verdict: Approve Stanislaus Tinnemans st209645

([email protected])
Author Approval
11-Jul-2022 09:24:26 GMT+0000
Verdict: Approve Jason Fagg jf961655

([email protected])
Business Approval
11-Jul-2022 11:26:30 GMT+0000
Verdict: Approve Gordana Brajanoski gb616342

([email protected])
Quality Assurance Approval
ve 20-Jul-2022 07:47:13 GMT+0000
fe cti
Ef


SOP Managing Recalls

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SOP Managing Recalls

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GSK VQD-SOP-016604 v: 2.

0 Retrieved: 05 Apr 2023 Effective: 30 Sep 2022

acting Quality Head BeNeLux /

Quality Executive LOC NL / Responsible

Quality Lead BeLux / Responsible

Proprietary Information. Do not disclose without consent.

9 HISTORY OF CHANGE .............................................................................................. 15

Proprietary Information. Do not disclose without consent.

 medicinal products, including intermediate and bulk product

Proprietary Information. Do not disclose without consent.

Role Key Responsibilities

Recall Coordinator  Performing batch tracing activities, if not already performed

 Monitoring the progress of the recall

 Performing an effectiveness check on the recall

Quality (i.e. LOC  Managing and putting recalled product on hold

Proprietary Information. Do not disclose without consent.

GRB  Reviewing and, where required, approving changes to the recall in

Regulatory  Supporting the distribution of communication material, as required

Proprietary Information. Do not disclose without consent.

4.1 Seek Approval from

4.2 Appoint a Recall

4.4 Perform the Recall

4.5 Document a Summary

4.6 Close the Recall

4.7 Perform Product

Proprietary Information. Do not disclose without consent.

Step Instruction Responsible

4.1 Seek Approval from the Impacted Regulatory Authorities

Determine if any other regulatory authorities need to be notified, for

4.2 Appoint a Recall Coordinator

Proprietary Information. Do not disclose without consent.

appointing local recall coordinators.

4.3 Initiate the Recall

4.3.1 Using PRS, create and issue a recall notification. Product

communication plan developed during the PIRC. Incident Chair

4.3.6 For serialised products, communicate the decommissioning strategy to Product

4.3.8 For change requests to the class or level of a recall: GRB

4.4 Perform the Recall

Proprietary Information. Do not disclose without consent.

4.4.2 Send follow up communications, as required, to direct accounts / Recall

4.5 Document a Summary of the Recall

4.5.1 Using the Recall Summary Report Template, document: Recall

Proprietary Information. Do not disclose without consent.

product for each impacted market.

4.5.4 If the recall is assessed as ineffective, perform a risk assessment. Product

reconvene the product incident committee, communicate with or delegate

Proprietary Information. Do not disclose without consent.

 There is no outstanding regulatory activity and, if applicable, the

 Any telephone enquiry mechanisms have been discontinued

4.6 Close the Recall

Proprietary Information. Do not disclose without consent.

 regulatory authority recall closure letters

4.6.2 Retain all primary documentation in a suitable local documentation Product

Manage all recall documentation as critical and sensitive information.

the appropriate retention period has been selected

4.7 Perform Product Incident and Recall Simulations

Proprietary Information. Do not disclose without consent.

4.8 Perform an Effectiveness Check

Reference No. Reference Description

GQP 8205 Management of Product Incidents and Recalls