PR - Sop 8.5-04 Batch Recall Rev0

COMPANY LOGO COMPANY NAME
PHARMACEUTICAL CANNABIS
Date of Issue: Click or tap to enter a date.

PERSONNEL ENTRANCE and GOWNING in GRADE C and D
Effective Date: Click or tap to enter a date.
CLEANROOMS
Revision: 0.0 Work Instruction
Department: Production PR.WI 01-01
REVISION LOG
Version Date of Revision Date of Approval Revision Short Description
0.0 Click or tap to enter a date. Click or tap to enter a date. Initial Version
Author Approval
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Head of Production Operations/Facility Manager Page 1 of 9

CLEANROOMS
DISTRIBUTION LOG
Revision Short Distribution Date of Withdrawal

Version
Description Recipient Date Valid Copy (signature QAM)
Version: 1.0 MASTER
Head Of Production (PR) Click or tap to enter a date.
DOCUMENT
Date of Issue:
Click or tap to enter a date. Quality Assurance Manager 01
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Initial Version
Effective Date: Head of Quality Control (QC) 02
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Operations/Facility Plant Manager 03
Version: 2.0
Date of Issue:
Effective Date:
Version: 3.0
Date of Issue:
Effective Date:
Version: 4.0
Date of Issue:
Effective Date:
Version: 5.0
Date of Issue:
Effective Date:
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READ and UNDERSTOOD LOG
Department / Read and Understood

Version Name Date
Job Position (signatory)
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CLEANROOMS
1.0 PURPOSE and SCOPE
1.1 The purpose of this Work Instruction (WI) is to describe the gowning process that all employees
must follow prior entering Grade C or D cleanrooms of the facility.
1.2 All personnel prior entering Grade C cleanrooms specifically must undergo a gowning process
putting on specially made sterile gowning that do not shed fiber or particulate matter and retain
particles shed by the body, thus reducing the risk of particle shedding and contamination in Grade
C cleanrooms operations.
1.3 Gowning for entering Grade D cleanrooms is not required to be sterile.
1.4 This WI lists the approved garment clothing in each clean area and the details of gowning in a
standardized manner.
2.0 ROLES and RESPONSIBILITIES
2.1 The Production Manager (PR Manager) is responsible for the approval of this WI.
2.2 The Production Personnel (PR Personnel) and all other employees authorized to work in the
cleanroom areas are responsible for following this WI in an accurate and standardized manner.
3.0 REFERENCES
3.1 QA.SOP 7.1-17 Cleaning and Disinfection
3.2 (…)
3.3 (…)
3.4 (…)
4.0 ABBREVIATIONS
IPA Isopropyl Alcohol
LAF Laminar Air Flow
PR Production
WI Work Instruction
5.0 DESCRIPTION
The materials and consumables used for the implementation of this WI are listed in Table 1 below:
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Table 1. Gowning Consumables and Materials

Material Manufacturer Catalogue Number Warehouse Code
(…) (…) (…) (…)
(…) (…) (…) (…)
(…) (…) (…) (…)
(…) (…) (…) (…)
(…) (…) (…) (…)
5.1 Important Considerations
The following restriction apply to Grades C and D:
5.1.1 Entry with jewelry (watches, rings, necklaces, earrings, etc.) as well as the use of
cosmetics (make up and nail polish) are strictly forbidden.
5.1.2 The storage and eating of food, including chewing gum in any of the cleanrooms are strictly
forbidden.
5.1.3 Entry into Grade C cleanrooms with the basic gowning of Grade D is forbidden.
5.1.4 Exit to the common areas that are outside the Grade C and D cleanrooms of the facility
(e.g., toilets, office area, kitchen, meeting room, etc.) wearing gowning is forbidden.
5.1.5 Exit through the Emergency Exits while wearing gowning is forbidden except in the cases
set by the safety rules as described in the Emergency Response Plan.
5.1.6 Dust and particle adhesive mats are placed in front of entry points of the facility’s
production areas.
5.1.7 Hand sanitizers are placed in all entry points of the facility’s production areas.
5.2 Recall Locations
A product batch may be recalled from several different locations, including but not limited to:
5.2.1 Storage or other areas withing the manufacturing facility.
5.2.2 Various locations in the medicinal product supply and distribution chain (e.g., from the
distributor or the customer storage area).
5.2.3 End user location (e.g., the medical facility where a clinical trial takes place).
5.3 Recall Procedure
5.3.1 Every staff member who is a recipient of a complaint or of any other information related to a
product deficiency that may potentially result in a batch recall decision, is obliged to
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immediately notify the QP (or QP equivalent), the Heads of Production and QC, the
Cultivation Manager, and the Quality Assurance Manager, accordingly.
5.3.2 The Qualified Person (QP) is responsible for initiation the relevant investigation. The
preliminary investigation should, as per QA.SOP 9.1-01 Handling of Complaints and
Grievances, quickly conclude as to the criticality of the problem identified and whether it
poses potentially a significant risk to patient safety. The Qualified Person (QP) is
responsible for making the decision regarding a product batch recall, as well as for
coordinating the specific actions required to execute the recall. Any deviations identified
during the preliminary and the subsequent full investigation are handled as per
GMP.QA.SOP 8.7-01 Management of Deviations and Non-Conforming Work.
5.3.3 Upon the decision to recall a specific batch, the Production Department employee
responsible for managing the warehouse is immediately communicated the data regarding
the batch under recall. The information includes:
 Batch number
 Strain type
 Production and expiry dates of the batch
 Type of defect identified/reasons for the recall.
5.3.4 The corresponding inventory and shipping records are then checked to identify the exact
quantities and transfer locations related to that batch of product. If part of the batch under
recall is identified as having remained in the manufacturing facility finished product storage
area/warehouse, then these quantities are immediately identified and placed under
quarantine, while appropriate labels are attached as suitable. These labels clearly state
ATTENTION – PRODUCT BATCH RECALLED.
5.3.5 The Cultivation Manager is also immediately notified about the recall. The Head of
Production is responsible for checking the corresponding Batch Manufacturing Record to
verify the raw materials and consumables utilized and to confirm the initial batch size.
Depending on the root cause of the recall, it might be necessary to isolate certain raw
materials, packaging materials and/or consumables of the same lot numbers as those
utilized in the manufacturing of the batch under recall and place them under quarantine,
awaiting further investigation. Such a measure may be considered a necessary preventive
action, even when it is not immediately clear whether the root cause affects these materials
in some manner or not.
5.3.6 The Qualified Person/QP equivalent is responsible for communicating the required
information to the contact persons of the locations where the product needs to be removed
from. This information includes:
 The product name,
 The batch number,
 The product quantity under recall form that location,
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 The nature and the criticality of the problem causing the recall.
5.3.7 If the root cause of the batch recall consists of a critical deviation, then the required
communication takes place immediately in writing via email, as well as by phone call. The
QP shall confirm that the communication was effective and that the required information
has been received and understood. It might be considered necessary to initiate the
communication of the required information before all locations have been identified. In the
event of a large batch that has been distributed widely it may be deemed necessary to
issue a public statement upon approval by the senior management.
5.3.8 Shipping records should contain detailed contact information regarding the product’s
destination, and these records should be maintained readily available to those involved in
the execution of the batch recall. Customer contact details should be kept readily available
for communication purposes.
5.3.9 Clinical trial locations of investigational medicinal products are considered product
destinations and therefore contact details should be readily available in cooperation with
the clinical trial sponsor (if applicable).
5.3.10 The QP is responsible for reaching a final decision regarding the recalled product batch,
following the actions prescribed to be implemented once the recalled quantities are
delivered back to the manufacturing facility, as per PR.SOP 8.5-05 Handling of Returned
Products. These quantities are segregated and stored separately, under quarantine,
awaiting further handling and final disposal, if rejected, as per procedures regarding waste
management and the applicable legislation. Temporary storage areas are clearly labelled
as such. The products themselves are also clearly labelled by yellow label UNDER
CONTROL and by an additional label ATTENTION – PRODUCT BATCH
RECALLED.
5.3.11 A documented reconciliation is performed between the recalled quantities received and any
remaining stock and those initially manufactured as per the corresponding Batch
Manufacturing Record.
5.3.12 The implementation progress of the recall decision is monitored by the Qualified
Person/QP equivalent.
5.3.13 The QP is responsible for informing the competent authority and any persons responsible
for pharmacovigilance regarding the recall decision (if applicable). The QP is also
responsible for consulting with the above parties regarding the extent of the recall process
in the distribution network and any further actions considered necessary depending on the
associated risk imposed to patient and public health and safety. Competent authorities
should also be informed of any defective product batches that have not been formally
recalled because they have expired.
5.3.14 The QP is responsible for declaring the recall process terminated once all quantities have
been retrieved and the reconciliation concluded. The recall is documented in the
corresponding Product Batch Recall Incident Report (F.PR.8.5-04.01) which details
information regarding:
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 Identification of the batch recalled,
 The reasons behind the recall decision and the nature of the problem,
 The results of the root cause investigation, including any tests performed on reference
and retention samples,
 The actions undertaken to execute the recall and the time consumed. Any delays
should be identified and further investigated,
 The reconciliation calculations and the percentage of the total batch that has been
retrieved, thus allowing the recall to be considered as successful, considering any
quantities already consumed/used/administered or otherwise managed. It is important
to understand the importance of the timing a recall has been decided and how this
affects the overall outcome.
 The actions determined for handling the returned quantities and final disposal,
 The actions taken to prevent such issues from recurring,
 The revised risk assessment studies related to the problem and any change control
reports generated to tackle the identified problem.
5.3.15 A complete copy of the Product Batch Recall Incident Report (F.PR.8.5-04.01) and the
attached documented evidence is conveyed to senior management.
5.3.16 All batch recall incidents are subjected to annual review during management review and as
per provisions of QA.SOP 9.3-01 Management Review.
5.3.17 Batch recall incidents are documented in the Deviations Register (F.QA.8.7-01.01) and
are classified (Critical, Major, Minor) according to the criteria established for the related
deviation.
5.4 Mock Recall
5.4.1 The Qualified Person/QP equivalent is responsible for planning a mock recall exercise at
least every two (2) years, in collaboration with the Head of Production, the Head of QC and
the Quality Manager. The mock recall is recorded, and conclusions drawn for effectiveness.
The main objective of the mock recall is to evaluate the continuous suitability of the
established records and traceability systems in the facility. It is essential to test how fast
can a suspect batch be detected and controlled, as well as how efficiently can the required
reconciliation data be retrieved and communicated accordingly.
5.4.2 A mock recall is recorded in the Batch Recall Incident Report (F.PR.8.5-04.01) in a
manner that replicates all details of the simulation scenario as if it was an actual batch
recall incident. The time it takes to retrieve required information and the time it takes to
collect recalled quantities are also recorded and evaluated.
5.4.3 A mock recall facilitates personnel in familiarizing themselves with the required actions for
addressing and investigating the recall incident, while enabling the identification of
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problems and gaps in the traceability and the documentation aspects of the pharmaceutical
quality and the QMS/PQS in place. Any CAPAs required are handled as per QA.SOP 10.2-
01 regarding Corrective and Preventive Actions. Mock recalls should focus on the
efficiency of the internal procedures for handling and tracing the finished product.
6.0 RECORDS
6.1 A Batch Recall Incidents Record (R.8.5-01) is maintained up to date by the Qualified Person (or
QP equivalent) including all batch recall investigation reports, mock batch recalls, and all attached
documented evidence retained regarding the recalled product batches.
6.2 A Complaints Record (R.9.1-01) is maintained up to date by the Quality Assurance Manager. This
Record contains a separate subfile per complaint which in turn includes all related documentation
generated during the investigation of the complaint, along with all communication between the
parties involved.
6.3 A Deviations Record (R.8.7-01) is maintained up to date, to include issued Deviation Reports and
corresponding investigations.
6.4 The CAPA Record (R.10.2-01) is maintained up to date to include CAPA Reports and
corresponding evidence of timely and effective corrective and/or preventive actions implementation.
6.5 A Correspondence Protocol/Register shall be maintained up to date by the Qualified Person,

including all evidence regarding communications taken place during product batch recall incidents.
Author Approval
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PR - Sop 8.5-04 Batch Recall Rev0

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COMPANY LOGO COMPANY NAME

Date of Issue: Click or tap to enter a date.

Version Date of Revision Date of Approval Revision Short Description

Date of Issue: Click or tap to enter a date.

Revision Short Distribution Date of Withdrawal

Click or tap to enter a date. Click or tap to enter a date.

Date of Issue: Click or tap to enter a date.

READ and UNDERSTOOD LOG

Department / Read and Understood

0.0 Click or tap to enter a date.

Date of Issue: Click or tap to enter a date.

1.0 PURPOSE and SCOPE

1.3 Gowning for entering Grade D cleanrooms is not required to be sterile.

2.0 ROLES and RESPONSIBILITIES

3.1 QA.SOP 7.1-17 Cleaning and Disinfection

IPA Isopropyl Alcohol

LAF Laminar Air Flow

Date of Issue: Click or tap to enter a date.

Table 1. Gowning Consumables and Materials

5.1 Important Considerations

The following restriction apply to Grades C and D:

5.2 Recall Locations

5.2.1 Storage or other areas withing the manufacturing facility.

5.3 Recall Procedure

Date of Issue: Click or tap to enter a date.

 Production and expiry dates of the batch

 Type of defect identified/reasons for the recall.

 The product name,

 The batch number,

 The product quantity under recall form that location,

Date of Issue: Click or tap to enter a date.

Date of Issue: Click or tap to enter a date.

 Identification of the batch recalled,

 The actions taken to prevent such issues from recurring,

5.4 Mock Recall

Date of Issue: Click or tap to enter a date.

6.5 A Correspondence Protocol/Register shall be maintained up to date by the Qualified Person,

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