OneV-864687 v 1.

0 Approved on 06 Dec 2023

JSTM.CLO-MFG-006 Dispensing

PERFORMANCE OBJECTIVE

Operation: Operation and Cleaning of Dispensing.

Learning On completion of the JSTM, the Trainee will be able to properly complete.
Objective: • Dispensing of all raw materials in production.
• Complete required cleans of dispensing areas.
Scope of Training on performing dispensing of raw materials and the cleaning
Application: required post dispensing.
Reference • OneV-55598 – CLO-FRM-CLN-00049 Weigh Room Full Cleaning
Document(s): Form
• OneV-55495 – CLO-SOP-MAN-00073 Cleaning Procedure for
Weigh Rooms
• OneV-46808 - CLO-SOP-MAN-00067 The Dispensing of Raw
Materials
• OneV-46122 - CLO-SOP-MAN-00134 Handling of Linaclotide API,
Intermediate Beads and Finished Bulk Capsules
• OneV-55491 - CLO-SOP-MAN-00020 Operation of Mettler
Multirange Balances
• OneV-798827 – QPP01-02-002-CLO POMSnet Recipe and
Worksheet Change Management at Clonshaugh Site
• OneV-727154 - Accessing POMsnet related Procedures Clonshaugh
• IT50.07.016 - POMSnet Use for Weigh and Dispense
• IT50.07.017 - POMSnet Equipment Management
• Any BMR detailing dispensing can be used in training so long as the
Trainee has completed it on ComplianceWire.

Tools and • Purified Water

Materials: • IPA
• Mop
• Non-shedding Cloth
• Vacuum
• Scoops
PPE: As per process room requirements.

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I. TRAINING OUTLINE
Trainer Note 1
• Trainer to complete the reason for training.
• Ensure the Trainee has read and understood the reference documents on
ComplianceWire prior to commencing training including the BMR used for training.
• The following attention activators are used throughout the JSTM:
Stop and Check Attention Verification required.

Reason for Training:

□ Initial Qualification □ Requalification* □ Other, please specify: _____________
* Requalification should be documented in JSTM.CLO-MFG-F01. If direct observation is
required only the independent runs should be completed. If the requalification outcome is ‘fail’
at minimum one demonstration, training assist and independent run should be performed
where applicable.
What is the Purpose of Dispensing?
Dispensing is a critical task that ensures the correct amount of raw material is weighed in
preparation for drug production. Accurate dispensing means each product receives the correct raw
materials and amount to formulate, ensuring correct drug and dosage is administered to patients.
What are the consequences of missed/incorrect dispensing of raw materials?
A missed dispensing will delay batch processing and may interrupt the patient supply.
Dispensing the incorrect material / quantity could impact the quality of the drug delivered to the
patient and result in product recall.
Key Dispensing Considerations
• Different lot numbers of raw materials should not be mixed in a dispensed container, they
should be dispensed into separate containers. Only one lot number of raw material should
be introduced to the weigh room at any one time.
• If different lot numbers of raw material are required to fulfill the dispensing order a part
clean and area clearance must be performed before transfer of the second lot into the room.
• Dispensing operators should not select the material they are going to dispense, instead a
separate operator should. This ensures two sets of checks are performed on the raw material
prior to dispensing.

Effectiveness Check #1
Trainer to verify Trainees understanding on the purpose and importance of dispensing to drug
production and has confirmed that the Trainee has completed the read and understand training
of reference documents (Page 1) on ComplianceWire.

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Trainer Note 2
• Demonstrate the performance of room clearance and material check-in to the Trainee
then complete the supervised and independent runs as required.
• Explain to the trainee that balances must be verified to be operating within
specification once per day. This training is document in JSTM.CLO-MFG-005
Room Clearance and Material Check in:
1. Log into POMsnet and open the dispensing worksheet.
2. Select the required room and the process order for dispensing.
3. Perform Room Clearance, with supervisor sign off. Checks of equipment should
include:
• Ensure the Laminar Down-flow booth and associated equipment are clean and
ready for use. This will include checking cleaning forms and associated logbook
as required.
• Check that the “Power On” LED of the Laminar Down-flow booth is illuminated
on the Local Operator Panel.
• Check to ensure the system flow, prefilter condition and HEPA filter condition
gauges are all within the “Green Zone” on the Laminar Down-floor booth Local
Operator Panel.
• Check the daily verification check is complete on the balance, and the balance
bubble is centered.
• Check the differential pressures inside/outside Laminar Down-Flow booth and
ensure they are within specification before proceeding.
• Check that the description on the material label and the material code match the
codes on POMsnet.
• Inspect raw material containers to ensure they are clean and free from damage.
• Check in the process room and equipment that will be used to dispense on the
worksheet. This will check the status to ensure the equipment / room is clean and
change their status to ‘in use’.
4. Transfer raw material into the weighing room.
Effectiveness Check #2
The Trainee successfully observed, performed with assistance, and performed independently
Room Clearance. At least one demonstration, one training assist run and one independent run
should be completed. If the Trainee demonstrates competence during the first run, the second
training assist or the second independent run can be N/A.

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Trainer Training Training Independent Independent

Training Material
Demo Assist #1 Assist #2 #1 #2
Batch
Number
Material
Room
Code
Clearance
Trainee
Initial &
Date

Trainer Note 3
• Demonstrate the performance of dispensing of raw materials to the Trainee then
complete the supervised and independent runs as required.
• Explain to the trainee that balances must be verified to be operating within
specification once per day. This training is document in JSTM.CLO-MFG-005
Dispensing of Raw Materials:
1. Zero the balance.
Note: Ensure Daily Verification Check of balance has been performed.
2. Place the empty product container, double lined with PE bags on the balance and tare.
3. Dispense material to the required weight. The tolerance bar displayed on the POMs
screen will go green when the correct weight is achieved.
Note: When dispensing the PE bags should not be removed from the container.
4. Select ‘Record Weight’ and ‘Commit’ then follow the instructions on the
worksheet. The system will then print two duplicate labels.
5. Seal the PE bags and label the bag with one label.
6. Put a lid on the container and stick the second label on the outside body of the container.
7. Place the container on a clean palette.
8. Weigh the remaining raw material and print a new label on POMs.
9. Seal the container and label with the POMs label and a part container label.
Effectiveness Check #3
The Trainee successfully observed, performed with assistance, and performed independently the
Dispensing of Raw Materials. At least one demonstration, one training assist run and one
independent run should be completed. If the Trainee demonstrates competence during the first
run, the second training assist or the second independent run can be N/A.

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Trainer Training Training Independent Independent

Training Material
Demo Assist #1 Assist #2 #1 #2
Batch
Number
Dispensing Material
of Raw Code
Materials
Trainee
Initial &
Date

Trainer Note 4
• Explain to the Trainee that Linaclotide is a temperature sensitive, extremely potent API
that can become airborne easily. Emphasize the importance of completing dispensing
following procedure to ensure the API is dispensed safely for those involved and
correctly for the patient.

Handling of Linaclotide:
1. Linaclotide API should not be stored out of the freezer for longer than 24 hours.
Containers should be returned to the freezer immediately after dispensing, ensuring
that the temperature of the freezer storage unit is 20oC +/- 5 oC.
2. Linaclotide handling and dispensing must be carried out under a relative
humidity of <60%. If the room humidity is >60% do not continue and notify your
supervisor.
3. Linaclotide API can undergo up to four freeze thaw cycles prior to use without
requiring retesting. If the API has undergone four freeze thaw cycles before
dispensing, inform your supervisor.
4. Linaclotide API dispensing must be carried out under laminar flow and a Versiflow
Hood / Jupiter Hood should be worn at all times as it is extremely potent and becomes
airborne easily.
Dispensing of Linaclotide API:
1. Retrieve API from the Walk-In Freezer 7064 Dispensed Material Storage and record
the removal of the API in the Freezer logbook.
Note: Linaclotide API must be out of the freezer and thawed for no less than 4
hours before dispensing.
2. Follow the same instructions as described above for room clearance.
3. Place the API containers on the tabletop and slowly open the lid to prevent static build
up. Static build-up can result of a dust cloud of Linaclotide escaping.
Note: If the API is in a glass container, do not tap the glass container off the side of the

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stainless-steel dispensing container or countertop to loosen the wedged material.

4. Dispense the API following the same instructions as described above for dispensing
raw materials. All quantities of materials dispensed should be documented on the
inventory control system.
Note: Linaclotide API should be dispensed into 20L double polyethylene bag lined
HDPE white container with red screw cap lids.
5. On completion of dispensing replace the Linaclotide container lid and secure tightly.
Complete this for all Linaclotide containers including any empty containers for
disposal.
Note: As the empty containers may still contain traces of API, all empty containers
should be treated as chemical waste.
6. Wipe the outside of all containers with a clean dry cloth to remove any Linaclotide
residue and place the container into PE bag.
7. Where dispensed material is required for immediate use, the API should undergo
subsequent processing as specified in the Batch Manufacturing Record.
Note: Linaclotide API must not be out of the freezer for longer than 24 hours.
8. Where the material is pre-dispensed, production should place the dispensed material
into Walk in Freezer 7064- Dispensed material storage.
Note: Pre-dispensed API can be held in the freezer for up to 12 weeks in the container.
9. Upon placement in the freezer, populate the Freezer 7064 logbook and ensure it is
signed by appropriate personnel.
Effectiveness Check #4
The Trainee understands the importance of correct handling of Linaclotide and has
successfully observed, performed with assistance, and performed independently its dispensing.
At least one demonstration, one training assist run and one independent run should be
completed. If the Trainee demonstrates competence during the first run, the second training
assist or the second independent run can be N/A.
Trainer Training Training Independent Independent
Training Material
Demo Assist #1 Assist #2 #1 #2
Batch
No.
Linaclotide
Dispensing Trainee
Initial &
Date

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Trainer Note 5
• Demonstrate the Cleaning Process to the Trainee then complete the supervised and
independent runs as required.
• Explain to the Trainee that a part clean is performed between weighing of non-active
raw materials, or when using different lot numbers of the same material.
Part Clean of Weigh Rooms:
1. Wipe down all drums / pallets with 70% IPA to remove any residue.
2. Transfer drums / pallets out of the weigh room.
3. Clean the floors, stainless steel surfaces, and all miscellaneous equipment in the weigh
room using the room dedicated equipment and specified chemicals.
4. Clean the Ante room and lobby to the same standard as the process room.
5. On completion of cleaning populate the weigh room cleaning and usage logbook and
notify the production verifier / supervisor that the area is ready for inspection.
Effectiveness Check #5
The Trainee has successfully observed, performed with assistance, and performed
independently a part clean of the weigh room. At least one demonstration, one training assist
run and one independent run should be completed. If the Trainee demonstrates competence
during the first run, the second training assist or the second independent run can be N/A.
Training Trainer Training Training Independent Independent
Material Demo Assist #1 Assist #2 #1 #2
POMsnet
Work
Part Order No.
Clean Trainee
Initial &
Date

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Trainer Note 6
• Demonstrate the Cleaning Process to the Trainee then complete the supervised and
independent runs as required.
• Explain to the Trainee that full cleans are performed after API or dye colour dispensing,
after 30 days since previous full clean if the dispensing booth has not been in use or
after 5 days since previous part clean if the dispensing booth has not be in use.
Full Clean of Weigh Rooms:
1. Initiate CLO-FRM-CLN-00049 Weigh Room Full Cleaning Form.
2. Dispose of scoops used to dispense API.
3. Wipe down all drums / pallets with 70% IPA to remove any residue.
4. Transfer drums / pallets out of the weigh room.
5. Clean the floors, walls, ceilings, windows, doors / door frames using the room dedicated
equipment and specified chemicals.
6. Remove wall grilles and trays to clean the area behind using the appropriate equipment.
7. Wipe down all stainless-steel surfaces and miscellaneous equipment (Bins, scoops,
printers, POMs screen, drums etc.) using 70% IPA. Lift and secure the balance to clean
underneath.
8. Clean the Ante room and lobby to the same standard as the process room.
9. On completion of clean sign off CLO-FRM-CLN-00049 and populate the weigh room
cleaning and usage logbook. Notify the production supervisor / deputy that the area is
ready for inspection
Effectiveness Check #6
The Trainee has successfully observed, performed with assistance, and performed independently
a full clean of the weigh room. At least one demonstration, one training assist run and one
independent run should be completed. If the Trainee demonstrates competence during the first
run, the second training assist or the second independent run can be N/A.
Trainer Training Training Independent Independent
Training Material
Demo Assist #1 Assist #2 #1 #2
POMsnet
Work
Full Order No.
Clean Trainee
Initial &
Date

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II. EVALUATION

Training Effectiveness Check #1

Trainer to verify Trainees understanding on the purpose and importance of dispensing to drug
production and has confirmed that the Trainee has completed the read and understand training
of reference documents (Page 1) on ComplianceWire.
Trainer Signature: Date:

Training Effectiveness Check #2

The Trainee successfully observed, performed with assistance, and performed independently
Room Clearance and is now deemed competent in its execution.
Trainer Signature: Date:

Training Effectiveness Check #3

The Trainee successfully observed, performed with assistance, and performed independently
the Dispensing of Raw Materials and is now deemed competent in its execution.
Trainer Signature: Date:

Training Effectiveness Check #4

The Trainee understands the importance of correct handling of Linaclotide and has
successfully observed, performed with assistance, and performed independently its dispensing.
Trainer Signature: Date:

Training Effectiveness Check #5

The Trainee successfully observed, performed with assistance, and performed independently a
part clean of the weigh room and is now deemed competent in its execution.
Trainer Signature: Date:

Training Effectiveness Check #6

The Trainee successfully observed, performed with assistance, and performed independently a
full clean of the weigh room and is now deemed competent in its execution.
Trainer Signature: Date:

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A signature and date following the Training Effectiveness Checks above indicates that a
Trainer has observed the Trainee performing the training effectiveness checks competently for
that section of training.
Note: The Trainee performs all effectiveness checks above until a demonstration of 100%
competence is achieved as determined by the trainer.

Trainer Comments:

Final Qualification: Trainee has demonstrated competence in all learning objectives.

Dept. UPI Trainee’s Printed Trainee’s Signature Date

Name

Dept. UPI Qualifier’s Printed Qualifier’s Signature Qualified

Name Date

END OF DOCUMENT

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REVISION HISTORY
No. Reason
Introduction of a new JSTM to govern training of Dispensing. Implementation as per OneV-
1 859023 “AND Manufacturing JSTM Introduction Quality Plan”. Created by Patrick Doyle,
Gerard Byrne and Erika McClelland.

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Description of Change

JSTM introduced for manufacturing training as per OneV-859023 "AND Manufacturing JSTM
Introduction Quality Plan"

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Document Approvals
Approved Date: 06 Dec 2023

Erika McClelland, Operations Development Program I

Approval Task (erika.mcclelland@allergan.com)
Verdict: Approve Department
04-Dec-2023 12:35:45 GMT+0000

Niamh Nolan, QA Technician 2 - Doc Controller

Approval Task (Niamh.Nolan@Allergan.com)
Verdict: Approve Quality Assurance
04-Dec-2023 14:06:33 GMT+0000

Cormac Phelan, Manager, Manufacturing

Approval Task (Cormac.Phelan@allergan.com)
Verdict: Approve Department
04-Dec-2023 14:07:27 GMT+0000

Noeleen Stanley, Training Coordinator

Approval Task (Noeleen.Stanley@Allergan.com)
Verdict: Approve Quality Assurance
06-Dec-2023 17:03:05 GMT+0000

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