Professional Documents
Culture Documents
Quality Manual
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Quality Manual
Contents
A Quality Manual documents the policies, • Purpose of the Quality
procedures, responsibilities, and Manual
documentation, that must be in place
for the facility to comply with their • Contents of the Quality
regulatory responsibilities. Manual
• Relationship of the Quality
Manual to the Validation
Master Plan
• Examples of Quality Manuals
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Purpose of the Quality
Radiopharmaceutical
Production
Manual
The organization should establish and maintain a quality manual
that includes
Quality Manual
Contents
a) the quality policy
Purpose of the Quality b) the scope of the quality management system, including
Manual details of and justification for any exclusions
Contents of the Quality c) the documented procedures established for the quality
Manual management system, or reference to them, and
Relationship of the
d) a description of the interaction between the processes of the
Quality Manual to the
quality management system.
Validation Master Plan
Examples of Quality
Manuals
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Contents of the Quality
Radiopharmaceutical
Production
Manual
• A quality manual is a document that a facility writes to explain
which regulations are applicable to the facility (i.e. which
Quality Manual
regulations will be followed by the facility.)
Contents
• The regulations that are to be followed are based on the
Purpose of the Quality
process(es) that are performed at the facility.
Manual
• The facility’s Quality Manual should outline which regulations
Contents of the Quality
are going to be followed, how they are going to be followed,
Manual
who is responsible for ensuring that the regulations are
Relationship of the
followed, and which of the companies approved procedures
Quality Manual to the
address the regulations to be followed. If all parts of a regulation
Validation Master Plan
are not going to be followed, a facility may want to include a
Examples of Quality
brief explanation as to why a part of a regulation is not
Manuals
applicable to the facility and therefore will not be outlined in the
Quality Manual.
• The Quality Manual should be written in general terms with
minimal specifics. The format of a Quality Manual is usually
different than the format used for the facility’s other approved
documents. The format should still include such things as a
facility’s name, version control, and approval signatures.
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Contents of the Quality
Radiopharmaceutical
Production
Manual
• The following are examples of sections that a Quality Manual
should contain:
Quality Manual
– Table of Contents
Contents
– Introduction
Purpose of the Quality
– Facility Background
Manual
– Purpose
Contents of the Quality
– Scope
Manual
– Quality Policies and Objectives
Relationship of the
– Organization and Structure of Documentation
Quality Manual to the
– Facility’s Products
Validation Master Plan
– References
Examples of Quality
– Quality Policies for Specific Regulation Elements
Manuals
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Contents of the Quality Manual
Radiopharmaceutical
Production • Quality Policies for Specific Regulation Elements: This section will
encompass the majority of the manual. It will include each
regulation that will be followed by the facility, a brief description of
Quality Manual how the facility intends to follow the regulation, and a list of the
Contents
approved documents (by document name and number) that the
Purpose of the Quality
facility has in place which specifically address/discuss the facility’s
Manual
policies and objectives as stated in this section of the Quality
Contents of the Quality
Manual.
Manual
– Example: Purchasing Controls; Procedures are established and
Relationship of the maintained to ensure that materials, supplies, and services impacting
Quality Manual to the the Quality System and procured by facility X purchasing department,
Validation Master Plan conform to specified requirements.
Examples of Quality • Receiving Procedure SOP # XX. 01 Vendor Qualification Procedure SOP #
XX. 01 Release of In-coming Goods Procedure SOP # XX. 01 ......
Manuals
– Example: Corrective and Preventive Action; At facility X, Corrective
and Preventive Actions are integral in a variety of programs.
Whenever possible, these programs make an effort to determine the
root cause of the incident and to implement appropriate actions to
prevent the reoccurrence of the incident. Quality Assurance approves
all Corrective and Preventive plans and tracks their completion and
effectiveness.
• CAPA Procedure SOP # XX. 01 Material Review Board SOP # XX. 01
STOP Failure Investigation Procedure SOP # XX. 01 .......
Contents of the Quality Manual
Radiopharmaceutical Topics that should be covered in the final section on
Production Quality Policies for Specific Regulation Elements
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Relationship of the Quality Manual
Radiopharmaceutical to the Validation Master Plan
Production
• Quality Manual: The quality manual is a document that a
facility writes to explain which portions of which regulations are
Quality Manual
applicable to the facility and which documents the policies,
Contents
procedures, responsibilities, and documentation, that must be in
Purpose of the Quality
place for the facility to comply with these regulatory
Manual
responsibilities
Contents of the Quality
Manual
Relationship of the
• Validation Master Plan: The Validation Master Plan is a
Quality Manual to the
summary plan which communicates management’s
Validation Master Plan
expectations and commitments to be followed for the sites
Examples of Quality
validation program including the responsibilities and is therefore
Manuals
a key document at a site. It describes the program to be
conducted to get the items in question in a validated manner.
The plan lists all of the validation activities to be completed, as
well as the schedule for their completion. The term validation is
used to demonstrate with written evidence that the item under
consideration, e.g. process does what it purports to do.
Validation includes but is not limited to: equipment, computer
systems, production processes, cleaning procedures, facilities,
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utilities as well as analytical methods.
Example of a Quality Manual
Radiopharmaceutical
Production
• One approach to the Quality Manual is to delineate the quality
policies for specific regulation elements by making a flow chart
Quality Manual
of every process and then assigning the SOP or other
Contents
document which addresses that process to ensure that
Purpose of the Quality
everything is covered with an SOP. An example of this is shown
Manual
on the next slide.
Contents of the Quality
Manual
• Note that each process or activity has an SOP number or
Relationship of the
document associated with it.
Quality Manual to the • The SOP numbers starting with A are the administrative SOPs
Validation Master Plan while those starting with Q are the quality assurance SOPs.
Examples of Quality
Manuals
STOP
Radiopharmaceutical
Example of a Quality Manual
Production
QS001 Quality Policy
Examples of Quality Reagent and Solvent Log Post-Release Pre- and Post-Release Testing
Book Review O_M Procedures Testing Diagram, D004
Manuals Q002, Q011, Q013, Q018, Q020,
Component Inventory Q034
Review Q021Q026, Q031, Q032, Q034,
Batch Record Q022
Q035, Q044,
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Radiopharmaceutical
Example of a Quality Manual
Production
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