I Q M e d i c a l S e r vi c e s DOCUMENT NO.

: SRC-009-05 REVISION: 5 EFFECTIVE DATE: JULY 17TH,

2023
Site Readiness for Production & QC Lab New Tracer Application (EUP)

Site Readiness: Production & QC Lab New Tracer Application (EUP)

Site Information Local Customer Personnel Information Consultant Information
Name: Name: Name:
Address: Phone: Cell:
GON: Email: Email:
Site Phone:
A. Data from Customer Verified By / Date & Comments
1. PET Center Infrastructure and Environmental Facilities Yes No
1. HVAC Installed and Tested (Heating, Ventilation and Air Conditioning).
Temperature stability is critical for this application.

QC room-Temperature (18 +/-2° C) and Humidity of 45+/-10%RH

All activities that can affect the environment of the equipment must be (✓ ) ( )
finished before this visit.

All other areas should meet your final layout specifications and must be
human comfort level.
2. Temperature and Humidity data loggers are installed in the rooms.
( ✓) ( )
Calibration certificates are required for site following GMP.
3. Internet connectivity at the site is operational. Consultants will require
(✓ ) ( )
temporary internet connectivity for their PC’s.
2. Local installations and with related certificates Yes No
1. Gas tank valves and gauges have been labeled with gas type, purpose,
regulated pressure, and tolerance. Same with regulators and valves located (✓ ) ( )
at drop points. (All gas lines must be purged previous to start this activity).
2. Gas cylinder purity certificates are available on site. ( ) ( )
3. Certification by external company that clean rooms (production lab and
microbiology lab) and the hot cells/ laminar flow hood meet the design air ( ) ( )
classification criteria.
4. L-block shield is assembled and placed in the operational QC fume hood If it applies
( ) ( )
and/or shielded hood.
5. Extra lead bricks are available for addition of shielding, where necessary. ( ) ( )

Customer Initials: ______________ SRC-009-05 Rev5

Effective Date: 07/17/23
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4302 SW 73rd Avenue, Suite #2, Miami FL33755 I +l.305.290.4176 I iqmedicalservices.com
 I Q M e d i c a l S e r vi c e s DOCUMENT NO.: SRC-009-05 REVISION: 5 EFFECTIVE DATE: JULY 17TH,
2023
Site Readiness for Production & QC Lab New Tracer Application (EUP)

3. Installation, IQOQ of Other Main Devices and Consumables Yes No

1. Installation of the cyclotron, synthesizers, dispensing system, hot cells, QC
equipment, and radiation monitoring systems is complete: Cyclotron and
(✓ ) ( )
associated systems are operating reliably to produce the Isotope in Curie
quantities.
2. Synthesis box is installed and tested. ( ) ( )
3. Refrigerator and freezer are installed and operating for storage of requisite
( ✓) ( )
quality control consumables.
Consumbales FASTlab Gallium PSMA-11 cassette
4. All consumables required to produce and dispense at least 10 runs of each
( ) ( ) 10x1 & PSMA-11 precursor Vial 5x1 on the way to
radiotracer, are available onsite and ready to be used during the visit.
Vietnam as of 28 July
5. Target material, enough water, gas or solid target is installed and available ( ✓
( )
for 10 runs per tracer. )
6. All QC Consumables needed to do the routine QC procedures to test at
least 10 runs per tracer are available and ready to be used during the visit. ( ) ( )
(Based on the procedures which were previously agreed on)
7. All consumables needed to perform the Daily test of the equipment
(✓ ) ( )
(Balances, Dose calibrators, etc) are available onsite
8. The site has enough appropriate working attire for cleanrooms. (✓ ) ( )
9. Above consumables are not expired, damaged, or contaminated. Also, all
requisite consumables are kept in appropriate storage conditions as (✓ ) ( )
described on their container and/or certificate of conformity/authenticity.
10. Availability of the customer has been sent to IQMS in order to schedule a
tele- conference meeting. Here we will discuss what has expired
( ) ( )
(equipment, reagents and consumables) and what will be the next steps for
the customer prior to this visit.
11. Acknowledgement that Microbiology test (Sterility, Media-fill and Bioburden)
(✓ ) ( )
are customer’s responsibility.
4. Trained staff availability Yes No
1. Cyclotron, synthesizer, and automatic dispensing system operator training
( ) ( )
has been delivered.
2. Radiation Safety Officer (Radioprotection officer) will be present during the
IQMS representative visit. Site must indicate the name and regulatory (✓ ) ( )
agency authorizing the safety officer.

Customer Initials: ______________ SRC-009-05 Rev5

Effective Date: 07/17/23
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4302 SW 73rd Avenue, Suite #2, Miami FL33755 I +l.305.290.4176 I iqmedicalservices.com
 I Q M e d i c a l S e r vi c e s DOCUMENT NO.: SRC-009-05 REVISION: 5 EFFECTIVE DATE: JULY 17TH,
2023
Site Readiness for Production & QC Lab New Tracer Application (EUP)

3. Head of QC, QC Lab technicians, Head of Production, Cyclotron Operator

required to participate in the training should be available during the training
(✓ ) ( )
sessions. Please provide names, job titles, job responsibility, and
background information/previous work experience.
5. License, policy, permit, documentation availability
Yes No
1. The site Radioactive Materials (open and closed) License is still valid. (Verify
( ) ( )
with your local regulatory what will be needed)
2. Radiation safety policy has been written and is available at the site. ( ) ( )
3. Radiation exposure policy has been written and is available at the site. ( ) ( )
4. Dosimeter monitoring procedure has been written and logbook available at
( ) ( )
the site.
5. Instruction Manuals (or copies) for all equipment available onsite. ( ) ( )
6. Glassware and accessories Yes No

1. Vials shielding. ( ) ( )
2. 10 mL and 30 mL Vial ( ) ( )
3. Stopers ( ) ( )
4. HPLC filtration equipment is recommended ( ) ( )
5. Beakers ( ) ( )
6. Volumetric flask ( ) ( )
7. Decapper/crimper ( ) ( )
8. Automatic pipettors of 1000 and 100 L and its disposables tips ( ) ( )
9. TLC developer chambers ( ) ( )
10. Desiccator ( ) ( )
11. Scissors, or cutters ( ) ( )
12. Syringes ( ) ( )
13. Microliter syringe ( ) ( )
14. Eppendorf 1 or 2 ml ( ) ( )
15. Pyrogen free tubes ( ) ( )
16. Tongs, crucible ( ) ( )
17. Spray bottle 500 mL ( ) ( )
If don’t have the exact match let us know what you
7. Ga-PSMA (Ga-68) Yes No
find, so we can confirm that it can be used.

Customer Initials: ______________ SRC-009-05 Rev5

Effective Date: 07/17/23
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4302 SW 73rd Avenue, Suite #2, Miami FL33755 I +l.305.290.4176 I iqmedicalservices.com
 I Q M e d i c a l S e r vi c e s DOCUMENT NO.: SRC-009-05 REVISION: 5 EFFECTIVE DATE: JULY 17TH,
2023
Site Readiness for Production & QC Lab New Tracer Application (EUP)

a) Quality Control Equipment

1. HPLC System ICS with VWD ( ) ( )
2. Radioactivity detector (CsI) ( ) ( )
3. pHmeter ( ) ( )
4. MCA (with calibration sources) ( ) ( )
5. PTS reader (Endotoxin’s detector) ( ) ( )
6. Dose Calibrator (with source) ( ) ( )
7. Balance (with weights) ( ) ( )
8. Water purifier ( ) ( )
b) Quality Control reagents and consumables
1. Column, ACE C18; MAC-MOD Analytical; 100 angstrom Ultra-inert base
(x ) ( ) This was purchased with the equipment
deactivated analytical HPLC column, its guard and cartridge holder. Qty: 1
2. [68Ga]gallium PSMA-11 injection produced by the end user ( ) ( )
3. Gallium (68Ga) chloride ( ) ( )
4. pH indicators strip ( ) ( )
5. LAL cartridges-0.05 EU/ml cartridges (1 pack of 10). Qty: 1 PN: PTS2005F ( ) ( )
6. LAL Water 10ML ( ) ( )
7. Gallium PSMA-11 (minimum 95.0 per cent (anhydrous and trifluoroacetic
( ) ( ) On the way to Vietnam as of 28 July
acid-free substance) Qty: 1 mg.
8. PSMA-11 Qty: 1 mg ( ) ( ) On the way to Vietnam as of 28 July
9. Trifluoroacetic acid Qty: 10 mL ( ) ( )
10. Acetonitrile Qty: 6 L ( ) ( )
11. Ethanol Qty: 50 mL ( ) ( )
12. Hydrochloric acid Qty: 10 mL ( ) ( )
13. Sodium hydroxide solution 50% Qty: 5 mL ( ) ( )
14. Pentetic acid Qty: 5 gs ( ) ( )
15. Ammonium acetate Qty: 20 gs ( ) ( )
16. Methanol Qty: 50 mL ( ) ( )
17. TLC plate: Agilent ITLC SGI0001 Qty: 1 sheet ( ) ( )
18. Water (HPLC or form Millipore Direct-Q water system) Qty: 6 L ( ) ( )
8. Approval
Yes No Verified By / Date & Comments
a. Do you approve of IQ Medical Services to start work at the Site?
(✓ ) ( ) Approval Date: ________________
b. Additional visits or longer stays at the site due to these inconsistencies will be
( ) ( )
Customer Responsibility and will be quoted separately.

Customer Initials: ______________ SRC-009-05 Rev5

Effective Date: 07/17/23
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4302 SW 73rd Avenue, Suite #2, Miami FL33755 I +l.305.290.4176 I iqmedicalservices.com
 I Q M e d i c a l S e r vi c e s DOCUMENT NO.: SRC-009-05 REVISION: 5 EFFECTIVE DATE: JULY 17TH,
2023
Site Readiness for Production & QC Lab New Tracer Application (EUP)

Important Customer Information

1. If you have questions or problems in providing anything described as Customer Responsibilities above, please contact IQMS for assistance prior to
delivery. In addition, IQMS and/or it's partners reserve the right to reschedule the installation dependent upon the readiness of your laboratory.
2. Should your site not be ready for whatever reasons, please contact IQMS as soon as possible to rearrange any services that have been purchased.
3. During training, users of the instrument should be present throughout this session; otherwise, they will miss important operational, maintenance and
safety information.
4. Regarding duplicates reagents and consumables in different tracers, write in the comments the total amount of the material and confirm with iQMS
personnel to ensure the quantity is enough to perform all tracer where these consumables and reagents are listed.

Final Comments (Customer):

Final Comments (IQMS):

Accepted By: Date:

Consultant:

Reviewed By: Date:

Global Project Manager:

Local Project Manager:

IQMS Project Manager:

✓ Ticked by GE Project Manager

Customer Initials: ______________ SRC-009-05 Rev5

Effective Date: 07/17/23
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4302 SW 73rd Avenue, Suite #2, Miami FL33755 I +l.305.290.4176 I iqmedicalservices.com