Mock Recall
Step by step process
Step Action Responsible Support Document Output
Define the scope of the Prepare a protocol for the recall, Site QP Site management, Protocol Define who should be informed,
mock recall ▪ At minimum it will cover steps described in the Operations/ Risk Precise example (e.g. coloration
recall procedure. Management in a eye drop product, batch
▪ It could also include verification of the system in Team number(s))
place to ensure that Designated Managers are Date of mock recall
contactable in case of pharmaceutical emergency
Step by step roll out of the mock
or of serious events impacting the quality of the
recall as expected which will
products and services (e.g. Out of business hours
allow evaluation & gap analysis
call for critical issue)
at the end of the exercise.
▪ It should define if API site or other drug product
sites will be involved
Mock recall Launch the mock recall: Site QP Actions initiated
T0: Identification of a
Inform site team of a potential non-compliance Documentation of steps &
potential non-compliant
results started
issue (customer complaint,
internal deviation, other) Preliminary analysis of the defect and evaluation of Site QP Site management, Quality Alert
the risk -> potential recall situation Operations/ Risk Report (QAR)
Management
Team
Inform Risk Management Send a QAR Site QP Operations QAR within 72 Note clock starts if market alert
Team (Quality Alert hours procedure is applicable (3 days
Management) – T0 + 72 h to notify)
Preliminary investigation Investigation of batch records and QC results, initiate Site QP Operations Phone / e-mail Preliminary evaluation of extent
traceability of components, maintenance operations… Existing Team & immediate action plan in
and contact, as appropriate, other sites (API, drug documentation place.
product sites), suppliers.
Initiate inventory of units (batch(es), number of units
Start investigation report
& countries where product has been shipped)
Review history of complaints, AE,…
Quality Review Board - Arrange a meeting to review technical information Risk Site QP, Site Meeting Issue interim investigation report
QAR + 24 -48h and available data (complaints, …) Management management, minutes, Preliminary risk assessment
Team Operations Position paper
Decision to call for a steering
Coordination
committee meeting
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Mock Recall
Step by step process
Step Action Responsible Support Document Output
Complete risk evaluation, Contact Medical Affairs or Pharmacovigilance Risk Medical affairs, Position paper Final patient risk evaluation –
as needed Management Pharmacovigilance Class of defect
Team
Coordination
Complete investigation, as Gather all data available, root cause (identified, Site Operations Interim • Production & control
applicable potential or unknown), list of batches potentially investigation investigation
impacted and countries report(s) • Retained samples
• Analysis of return sample
• Traceability of Material
• Batch size & distribution from
site
• Other batches impacted
Quality Alert Committee Arrange the meeting with appropriate members of the Risk Meeting minutes Decision to block stock/s
meeting committee as defined in the recall procedure Management Quality Alert Decision to recall, propose level
Team and of the recall (distribution /
country hospital/ patient)
affiliate/s
Countries informed
Complete stock inventory Based on site inventory, Country MAH Office & Supply chain Risk management Table of Knowledge of current stocks,
distribution centres are contacted to provide current coordination Team traceability clear view on stock rotation ->
stocks, date of distribution and if appropriate, stocks & country affiliates actual risk of shortage
of other batches ready to be distributed depending on the level of the
recall & impact on patient risk
Site recall team Identified members of local recall task force, if Site QP Operations and Action plan, Readiness for inspection,
needed Risk Management reports answer to authorities.
Team
External communication Finalise communication to Authority Risk Steering Communication Readiness for communication to
Management committee paper, text of authorities
Team the recall
Recall Implementation of recall Country Risk Management
Office (MA Team coordination
holders) & country affiliates
Not part of the mock recall
Recall follow up & closure Get all traceability on product return management Country Risk Management
Office (MA Team coordination
holders & country Office/s
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Mock Recall
Step by step process
Step Action Responsible Support Document Output
Implement corrective Follow up on action plans to avoid recurrence of the API & Drug Operations Site CAPA Risk control
actions same defect. Product site
Close recall internally and with Regulatory Authority
Evaluation of mock recall Review each steps / documents / traceability/ site QP All involved Conclusion of Corrective And Preventive
Decisions versus the protocol; identify strengths & departments mock recall Actions, as applicable
weaknesses
Note:
Mock recalls should be performed annually.
Depending on size of organisation, typically the Risk Management Team would be based at the site which holds the marketing authorisation for the recalled
product. This group will work with the QP, API/Drug product manufacturer and senior management at the MA holder site in documenting the risk and
communicating with the respective regulatory authority.
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