Checklists

Staffing
This checklist is based on IAEA Guidance on Hospital Radiopharmacy - A safe and Effective Approach.
Please note: units operating at Operational Level 1 should complete the first checklist -Self Assessment for Operational Level 1.
However those units operating at Operational Level 2 should complete both checklists - Self Assessment for Operational Level 1 &
Additional Self Assessment for Operational Level 2.
Self Assessment for Operational Level 1

Verifiable Manual, Reference
documents, SOP, QC data, file record Date
No Component Class Y/N etc. Comments/ Planned Action achieved.
1.1 Is there a professional responsible for the A
radiopharmacy? Provide details.
1.2 Is the radiopharmacy unit operated under the A
direction of a person with appropriate
training as defined by local or national
regulations?
1.3 Are there written staff training manuals for B

all grades of staff?
Additional Self Assessment for Operational Level 2

Have all staff working at operational level 2
2.1 received specific staff training on the A
following:
Calibration of equipment- please

2.1a provide details and training records A
Working practices in the
2.1b radiopharmacy - please provide A
details and training records
Preparation of individual doses -
2.1c please provide details and training A
records
Quality control and analytical
2.1d techniques - please provide details A
and training records
Dose release - please provide details
2.1e A
and training details
Record keeping - please provide
2.1f A
details and training records
Cleaning - please provide details
2.1g A
and training records
Is there a system for formal approvals of all
documentations including
2.2 radiopharmaceutical (RP) preparation, QC B
and formal release to patient?
What training is provided to staff performing

2.3 final checks on all products prepared before A
release for patient use?
Are there training records for all staff

2.4 performing cell labelling, e.g. RBC, WBC? B
Is there an annual performance review to

2.5 check the competencies of radiopharmacy B
staff?
Facilities
Verifiable Manual, Reference documents, Date

No Component Class Y/N SOP, QC data, file record etc. Comments/ Planned Action achieved.
Does the unit have appropriately
finished rooms (including adequate
1.4 lighting, appropriate finishes to walls, A
floors, ceilings and ventilation) and a
shielded dispensing station?
Is there a shielded dispensing station
1.5 A
available?
For operational level 1b is there a

shielded dispensing station and/or a
1.6 a fume hood available? [Is there a fume A
cupboard with suitable filters for volatile
radioactive materials such as 131I
solutions?]
[If only radioiodine capsules are
1.6 b handled is the package opened in a A
well ventilated area?]
Is there a validated (annual check on
1.7 air-flow, safety and challenge testing) A
fume hood with suitable filters for
handling radioiodine solutions?
Are there records and logs kept for all
equipment irrespective of whether
1.8 maintenance and calibration is B
performed in-house or by external
contractors?
Verifiable Manual, Reference documents, Date

No Component Class Y/N SOP, QC data, file record etc. Comments/ Planned Action achieved.
For operational level 2: Are there
regular checks on validated Class II
type B microbiological safety cabinets
2.6 located in a dedicated room? A
Are monometer readings of pressure

2.7 differentials across HEPA filters B
recorded daily?
Are there periodic records of air
2.8 velocities determination for LAF B
cabinets or isolators?
Is challenge testing of the HEPA filters

2.9 in LAFs and isolators carried out B
annually?
For negative pressure isolators: Before

preparation takes place, are gloves or
2. 10 gauntlets visually inspected and B
integrity tests carried out and recorded?
Is there a system and record of planned
preventative maintenance for all
equipment in the radiopharmacy
2.11 including the refrigerator? B
When clean rooms are used, are the

over-pressures gauges monitored and
2.12 recorded daily? B
Puchase of materials

documents, SOP, QC data, file record
No Component Class Y/N etc. Comments/ Planned Action Date achieved.
Are there suitable protocols and
trained staff for the purchase of
1.9 approved or Marketing A
Authorized
radiopharmaceuticals?
Are all goods received checked

1. 10 and recorded against the order B
for correctness of delivery?
Are records kept for batch

1.11 numbers and quantities received? B
Are visual inspections and label

1.12 checks carried out prior to B
acceptance?

documents, SOP, QC data, file record
No Component Class Y/N etc. Comments/ Planned Action Date achieved.
Do all products, kits and
generators have product
2.13 approval, marketing A
authorisation, or bear a product
licence number?
How many unlicensed or

unapproved products are used
2.14 each year and is there a record of A
them?
For all unlicensed kits,

radiopharmaceuticals or radio-
chemicals are the prescribers or
2.15 responsible medical doctors A
made aware of his/her
responsibilities?
Do the suppliers or reagents and

unapproved products provide a
2.16 "Certificate of Analysis"? B
Dispensing protocols
Please note: that units operating at Operational Level 1, using pre-prepared pharmaceutical products, should complete the first checklist- Self
Assessment for Operational Level 1 & 2.
Units operating at Operational Level 2 and preparing own pharmaceuticals should also complete the checklist with regards to
dispensing protocols - Self Assessment for Operational Level 1 & 2.
Self Assessment for Operational Level 1 & 2

Are there specific written
radiopharmacy procedures for
dispensing operations undertaken in
1.13 the radiopharmacy? B
Under operational level 1a: Are there

written procedures for the aseptic
dispensing and labelling of unit doses
1.14 B
of ready-to-use
radiopharmaceuticals?
Is there a system for labels which

assesses quality, number produced
1.15 and number applied to dispensed A
doses?
For operational level 1b: Do the
written procedures contain clear
safety and monitoring instruction for
1.16 dispensing radioiodine solutions or A
capsules?
Under operational level 1b are there

written procedures for calibration
assay, preparation and dispensing of
1.17 individual patient radionuclide A
therapy?
Can the audit and documentation for

each RP batch be traced from the
prescription to the actual
1.18 administration of individual patient A
doses?
Preparation Protocols
All units operating at Operational Level 2 and preparing own pharmaceuticals must also complete the checklist below with regards to
preparation protocols (Self Assessment for Operational Level 1 & 2).

Are there written and approved
procedures for the use of generators
2.17 and reconstitution of each A
radiopharmaceutical kit used?
Are SOPs independently reviewed

2.18 and approved at specified intervals? B
Is the preparation of 99mTc

radiopharmaceuticals from kits and
2.19 generators carried out in a LAF A
cabinet?
Are there set criteria before release

for preparation for patients use? Is
2. 20 this undertaken by the same operator B
or a different individual?
Can each individual patient dose be

2.21 traced to a specific generator and kit A
batch number?
Under operational level 2b: Do the
written procedures for any
autologous preparation, e.g. red and
2.22 white blood cells, include a clear A
instructions on safety, cleaning and
decontamination?
Are there written procedures for the

preparation and dispensing of
2.23 approved kit formulations of radio- A
labelled biological e.g. monoclonal
antibodies, peptides?
QA & QC

Are daily QC checks performed on
1.19 radionuclide calibrators? A
What quality checks are undertaken on a

1. 20 supplier before purchase? B
Are periodic quality checks on

1.21 radiopharmaceuticals (RP) performed? B
Is there a written procedure for dealing with

1.22 product/s failing to meet the required B
standard?
Is there a record of complaint/s and any
1.23 associated follow-up and investigation? B
Are there written procedures and records for

regular contamination surveys of the
1.24 A
radiopharmacy unit?

For operational level 2 are there records for
2.24 the following:
Purchase of radioactive products

2.24 a and ingredients
Generator elution, yield, [99Mo]

2.24 b molybdenum breakthrough and
aluminium ion breakthrough
Product preparation, QC and

2.24 c release
Environmental and microbiological
2.24 d monitoring
Aseptic process, aseptic operator

2.24 e validation and trend analysis
Laboratory cleaning and B
2.24 f maintenance
Equipment and plant calibration
2.24 g and maintenance
Radioactive contamination
2.24 h monitoring and radioactive waste
disposal
Product defects and SOPs non-
conformance, i.e. when a procedure
is performed in a manner other than
2.24 i that described in the relevant SOP
2.24 j Independent inspection and audit
In line with the IAEA Operational guidance

on Hospital Radiopharmacy document, are
there records of routine microbiological
2.25 monitoring of the preparation area in the A
radiopharmacy?
Are there calibration and linearity checks of

the dose calibrator response over the
2.26 complete range of activities measured at A
least annually?
Is there set programme for checking the

2.27 quality of radiopharmaceuticals (RP)? B
Considering patient safety, are certain

simple checks performed on prepared
2.28 radiopharmaceutical, e.g. mini- A
chromatography?
For operational level 2 is a [99Mo]

Molybdenum breakthrough measurement
performed on the first eluate from each
2.29 [99mTc] Technetium generator and repeated A
when the generator is moved?
Is aluminium ion breakthrough checked on
the first eluate from a [99mTc] Technetium
2. 30 generator? A
Are changes in the source of any kits,

diluents or vehicle used, needles, syringes,
2.31 swabs and sterile containers used within B
radiopharmacy recorded?
On first use of a new batch or first new

2.32 delivery of RP kits is radiochemical purity B
performed?
Are rapid alternative methods employed for

swift prospective QC for critical RP e.g. the
2.33 determination of RCP for [99mTc] HMPAO)? A
Is there regular pH testing of RP carried

2.34 out? B
Prior to release for patients is each

2.35 individual radioactivity dose checked? A
Is there a record of the formal

approval/release by an authorized person
2.36 before a product is administered to a A
patient?
Are there written procedures for the recall of

2.37 defective products? A
Is there a record of complaints and any
2.38 associated follow-up and investigation? B
Is there a system of recorded self-inspection

2.39 and reports evaluation? B
Is there a system for external audit or peer

2. 40 review process? B
Waste

No Component Class Y/N documents, SOP, QC data, file record etc. Comments/ Planned Action
Are there written procedures for the
disposal of radioactive and non-
1.25 active waste specific to the A
radiopharmacy?
Is there a periodic review/audit of

arrival, use and disposal of all
1.26 A
radioactive materials?
Are there written logs for each solid

sources that indicate usage, transfer,
1.27 disposal of solid sources? A
Date
achieved.
Audit Summary
The audit summary below should be completed by all units in order to prioritise needs.
Critical priorities have the highest importance.
Major priorities are second to critical priorities however they should still be addressed in a timely manner
Minor priorities are areas which need addressing but do not require such urgent attention as the above two categories.
Critical priority
No: Class Comment/action Time frame Date achieved
Major priority
Minor priority

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Staffing

Self Assessment for Operational Level 1

1.3 Are there written staff training manuals for B

Additional Self Assessment for Operational Level 2

Verifiable Manual, Reference

Calibration of equipment- please

What training is provided to staff performing

Are there training records for all staff

Is there an annual performance review to

Self Assessment for Operational Level 1

Verifiable Manual, Reference documents, Date

For operational level 1b is there a

Additional Self Assessment for Operational Level 2

Verifiable Manual, Reference documents, Date

Are monometer readings of pressure

Is challenge testing of the HEPA filters

For negative pressure isolators: Before

When clean rooms are used, are the

Self Assessment for Operational Level 1

Are all goods received checked

Are records kept for batch

Are visual inspections and label

Additional Self Assessment for Operational Level 2

Verifiable Manual, Reference

How many unlicensed or

For all unlicensed kits,

Do the suppliers or reagents and

Self Assessment for Operational Level 1 & 2

Verifiable Manual, Reference

Under operational level 1a: Are there

Is there a system for labels which

Under operational level 1b are there

Can the audit and documentation for

Additional Self Assessment for Operational Level 2

Verifiable Manual, Reference

Are SOPs independently reviewed

Is the preparation of 99mTc

Are there set criteria before release

Can each individual patient dose be

Are there written procedures for the

Self Assessment for Operational Level 1

What quality checks are undertaken on a

Are periodic quality checks on

Is there a written procedure for dealing with

Are there written procedures and records for

Additional Self Assessment for Operational Level 2

Purchase of radioactive products

Generator elution, yield, [99Mo]

Product preparation, QC and

Aseptic process, aseptic operator

2.24 j Independent inspection and audit

In line with the IAEA Operational guidance

Are there calibration and linearity checks of

Is there set programme for checking the

Considering patient safety, are certain

For operational level 2 is a [99Mo]

Are changes in the source of any kits,

On first use of a new batch or first new

Are rapid alternative methods employed for