Radiopharmaceutical Production
Standard Operating Procedures
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Standard Operating Procedures
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Although useful reference documents
for inspectors, Standard Operating
Procedures (SOPs) are written for the
benefit of the persons carrying out the
operation in question.
They should be written so that the user
can easily understand them. If
possible, they should be written by or
with the operators, to ensure that they
accurately reflect what happens in
practice.
They will be written by the department
responsible for carrying them out, but
should also be approved by the QA
department, if appropriate.
Contents
• General Principles
• SOP Authorship
• SOP Format
• Where are SOPs needed?
• Example SOPs
STOP
General Principles
Radiopharmaceutical
Production
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
•
•
•
•
Where are SOPs
needed?
Example SOPs
•
STOP
Who is responsible for preparing SOPs? - they should be
written by or with the operators, to ensure that they accurately
reflect what happens in practice.
What is the format for an SOP? – There should be a
consistent format used for all SOPs
Which activities require SOPs? - Nearly all activities require
an SOP.
Where should SOPs be stored? - Master copies of
procedures should be stored by the responsible department or
centralized in the document control department. Authorized
copies of each procedure should be stored adjacent to the
place where the operation will be carried out, as a reference
document that can be consulted at will.
Are SOPs associated with records? - All critical equipment
should have logbooks in which maintenance and cleaning are
recorded. A record should also be kept of the use of this
equipment. The procedures for sanitation should include
methods, equipment, materials, responsibilities and the
schedule for carrying them out.
SOP Authorship
Radiopharmaceutical
Production
•
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
STOP
•
The author of the SOP should be
someone who is very familiar with
the procedure being performed. If
someone else writes the SOP, the
knowledgeable person should be
close communication with the
author and have the opportunity to
review and revise the procedure
before it becomes official.
The best procedure is to have all
the people who perform the
procedure discuss the SOP and
make comments. Then the author
takes these comments and
incorporates them into the SOP
SOP Format
Radiopharmaceutical
Production
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
STOP
The following are suggested contents for the SOP. On the following
slide is a description of the sections that could be included in the
SOP.
Header/Footer: The standard format is a Header with the SOP’s title,
number, and version identifier. The Header or a Footer contains
the page number of total number of pages (e.g. page 4 of 6), and
approval date.
Title Page: SOPs often have a title page with the author’s signature
and date, the reviewer’s signature and the final approval date with
a signature and date.
Documentation: The SOP brings up all supplementary documents,
and cross-references with other SOPs, as well as their location
both electronically and hardcopy. This is usually listed in the
References section of the SOP.
Records: The SOP states in the procedure where to annotate and
keep records (electronic and hardcopy).
SOP Format
Radiopharmaceutical
Production
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
STOP
The following are suggested contents for the SOP. On the following
slide is a description of the sections that could be included in the
SOP.
Responsibilities: The SOP assigns responsibility for the procedure.
Name and dated signatures are mandatory for SOP author,
reviewer, and approval.
Signatures: Authors, Reviewers, and Authorizing signatures should
be attached at the beginning or end of the document, with the
date of approval.
Materials: The SOP describes the materials used. Example: A
procedure involving a chemical compound (i.e. ethyl alcohol) will
indicate purity, concentration, amount, and any other pertinent
information.
Equipment: The SOP describes equipment, its function and
operational steps. Example: How to measure pH with the pH
meter.
SOP Format
Radiopharmaceutical
Production
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
STOP
Subject: The subject describes what the document applies to.
Example: This document applies to SOPs writing.
Purpose: This gives the purpose of the SOP. Example: This SOP
sets formatting standards for all SOPs used in this facility.
Scope: The scope describes to whom this procedure applies..
Usually this is the entire facility or program for small facilities.
Safety: The SOP addresses all safety issues regarding the task.
Example: The SOP describes any necessary steps to perform a
safe work (i.e. wear a mask) as well as the location of the
Materials Safety Data Sheets (MSDS).
Definitions: The definition of all terms that are crucial for the
understanding and correct performance of the procedure need to
be included.
Procedure: The SOP describes the steps to perform the procedure.
Where necessary will refer to supplementary documentation (i.e.
when there are a large number of steps).
References: Cite any references to manuals, diagrams, etc. here
Change History: Changes must be documented in the Change
History section of the SOP. This should include the date, the
revision letter (A, B, C etc) and a description of the change. The
header must reflect the change. Prior to changes in the electronic
copy of the SOP, changes and revisions can be entered in nonsmearing pen in the current original SOP along with the initials
and the date. Entry errors (ee) must be crossed out with a line
and initialed and dated. All hand-written changes to any cGMP
document must be accompanied by initials and date.
Where are SOPs needed?
Radiopharmaceutical
Production
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
STOP
SOPs are needed for all the following activities
• Equipment and analytical apparatus:
• - Assembly, validation
• - Calibration
• - Internal labeling, quarantine and storage of materials
• - Operation
• - Maintenance and cleaning
• * Personnel matters:
– Qualification
– Training
– Clothing
– Hygiene
Where are SOPs needed?
Radiopharmaceutical
Production
Standard Operating
Procedures
Contents
General Principles
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
STOP
SOPs are required for a whole range of activities
within the facility and may include the following:
• Receipt of all material deliveries
• Internal labeling, quarantine and storage of
materials
• Operation, maintenance and cleaning of all
instruments and equipment
• Sampling of materials
• Batch numbering systems
• Material testing at all stages of production
• Environmental monitoring
• Pest control
• Complaints
• Recalls
• Returned goods
Example SOPs
Radiopharmaceutical
Production
Here are some examples of SOPs for writing SOPs
Standard Operating
Procedures
Contents
General Principles
For a simple SOP for a small operation. Follow the arrow
More
Simple SOP
SOP Authorship
SOP Format
Where are SOPs
needed?
Example SOPs
For a more complex SOP for a larger organization.
More
STOP
Sample Complex SOP
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