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Radiopharmaceutical Production

Quality Manual
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Quality Manual
A Quality Manual documents the policies,
procedures, responsibilities, and
documentation, that must be in place
for the facility to comply with their
regulatory responsibilities.

Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the Quality
Manual to the Validation
Master Plan
Examples of Quality Manuals
STOP
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Purpose of the Quality
Manual
The organization should establish and maintain a quality manual
that includes
a) the quality policy
b) the scope of the quality management system, including
details of and justification for any exclusions
c) the documented procedures established for the quality
management system, or reference to them, and
d) a description of the interaction between the processes of the
quality management system.

Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality
Manual
A quality manual is a document that a facility writes to explain
which regulations are applicable to the facility (i.e. which
regulations will be followed by the facility.)
The regulations that are to be followed are based on the
process(es) that are performed at the facility.
The facilitys Quality Manual should outline which regulations
are going to be followed, how they are going to be followed,
who is responsible for ensuring that the regulations are
followed, and which of the companies approved procedures
address the regulations to be followed. If all parts of a regulation
are not going to be followed, a facility may want to include a
brief explanation as to why a part of a regulation is not
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 facilitys other approved
documents. The format should still include such things as a
facilitys name, version control, and approval signatures.
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality
Manual
The following are examples of sections that a Quality Manual
should contain:
Table of Contents
Introduction
Facility Background
Purpose
Scope
Quality Policies and Objectives
Organization and Structure of Documentation
Facilitys Products
References
Quality Policies for Specific Regulation Elements


Table of Contents: A list of the sections contained within the
Quality Manuel and the page each section begins on.

Introduction: A brief description of the facility, the facilitys
purpose for writing a Quality Manual, and a brief description of
the scope of the Quality Manual.

Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality
Manual
Background: List the name of the facility, where the facility is
located, what radiopharmaceutical products are produced at the
facility, and how these will be distributed.

Purpose: Provide general statements explaining why and how
the Quality Manual will be used.
Example: This Quality Manual describes the quality management
system that has been established by facility X in order to meet
regulatory requirements for the production of PET
radiopharmaceuticals in the United State.

Scope: List the regulations that will be followed by the facility as
well as any portions of the regulations that will not be followed.
Provide a justification for why those portions of the regulations
are not going to be followed.
Example: The system described in this manual is intended to meet
general requirements set forth in the United States Food and Drug
Administration (FDA) Regulation according to 21CFR Part 210,
21CFR Part 211 and 21CFR Part 212 as well as the relevant
section of 21CFR Part 823.
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality
Manual
Quality Policies and Objectives: Include a brief statement about
the approach that the facility is taking in regards to quality, (i.e.
a Quality Mission Statement) and list the quality objectives of
the facility. The quality objectives should not be numerous (five
to seven is a typical number) and should be briefly stated.
Example: Customer issues are addressed in a timely, professional,
and thorough manner.
Example: Personnel are adequately trained in the job they perform
Example: Products and Services provided by our facility are
designed, manufactured, and delivered to our customers and meet
or exceed our customer requirements.

Organization and Structure of Documentation: Provide an
explanation as to how the documentation structure at your
facility is organized and managed in relation to the applicable
regulations.
Example: Documents related to the quality system are organized in
a hierarchy structure, are maintained in accordance with applicable
regulatory requirements and our facility record retention policy, and
are managed through a document change control system.
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality
Manual
Products: This section should include a brief description of the
products that are made and distributed by the facility including
what the intended use of the products is to be. This description
should be similar to a marketing type summary in that it does
not list proprietary or explicit product information that would be
detrimental to the facility if persons outside the facility read the
description. This section should provide enough detail to justify
the sections of the regulations that are and are not going to be
followed.

References: A list of all the different regulations that were sited
within the Quality Manual.
Example: FDA Title 21, Code of Federal Regulations Part 210 &
211, Current Good Manufacturing Practice in Manufacturing,
Processing, Packing, or Holding of Drugs and Finished
Pharmaceuticals, FDA Title 21, Code of Federal Regulations Part
212 PET Drugs Current Good Manufacturing Practice (cGMP),
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality Manual
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
how the facility intends to follow the regulation, and a list of the
approved documents (by document name and number) that the
facility has in place which specifically address/discuss the facilitys
policies and objectives as stated in this section of the Quality
Manual.
Example: Purchasing Controls; Procedures are established and
maintained to ensure that materials, supplies, and services impacting
the Quality System and procured by facility X purchasing department,
conform to specified requirements.
Receiving Procedure SOP # XX. 01 Vendor Qualification Procedure SOP #
XX. 01 Release of In-coming Goods Procedure SOP # XX. 01 ......
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
Failure Investigation Procedure SOP # XX. 01 .......
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality Manual
Deviations and Events
Event Recording
Reviews and
Investigations
Remediation
Change Control
Change Initiation and
Approval
Change Execution and
Tracking
Change Verification and
Closure
Audit Management
Planning
Execution
Review and Remediation

Document Management
Storing and
Classification
Access and Viewing
Creating New
Documents
Lifecycle Managements
Printing
Training Management
Employee Course
Management
Training Request and
Approval
Gap Management and
Records
Equipment Management
Inventory Management
Preventative Maintenance
Remedial Maintenance

Topics that should be covered in the final section on
Quality Policies for Specific Regulation Elements
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Contents of the Quality Manual

General Requirements
Security and Access Control
Facility Management
Corrective Action Preventive
Action (CAPA)
CAPA Initiation
Investigations and Action
Plan
CAPA Closure




Validation
Documentation Structure
and Formats
Change Control
Planning and Scheduling
Roles and Responsibilities
Regulatory Requirements
for Testing
A list of SOPs, Forms,
Validation Documentation
and other appendicies


Topics that should be covered in the final section on
Quality Policies for Specific Regulation Elements
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Relationship of the Quality Manual
to the Validation Master Plan
Quality Manual: The quality manual is a document that a
facility writes to explain which portions of which regulations are
applicable to the facility and which documents the policies,
procedures, responsibilities, and documentation, that must be in
place for the facility to comply with these regulatory
responsibilities

Validation Master Plan: The Validation Master Plan is a
summary plan which communicates managements
expectations and commitments to be followed for the sites
validation program including the responsibilities and is therefore
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,
utilities as well as analytical methods.

Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Example of a Quality Manual
One approach to the Quality Manual is to delineate the quality
policies for specific regulation elements by making a flow chart
of every process and then assigning the SOP or other
document which addresses that process to ensure that
everything is covered with an SOP. An example of this is shown
on the next slide.
Note that each process or activity has an SOP number or
document associated with it.
The SOP numbers starting with A are the administrative SOPs
while those starting with Q are the quality assurance SOPs.

Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Example of a Quality Manual
QA Unit
Post-Release
Testing
Personnel
Equipment
Control
Production
Process Control
Pre-Release
Testing
Batch Record
Facility Control
Document Control
Equipment
Qualification
Equipment Log Book
Review
Annual Document Review
Equipment Log
Books
Anomalies/
Deviations
Pre-Release
A008 A007
Master Equipment List
Review
Reagent and Solvent Log
Book Review
Internal Review
Waste Disposal
Employee Job
Training File
[
11
C] GMP
Process
Post-Release
Component Inventory
Review
Name/Signature Form
Q023
Q034
Non-Conformance Report
Q025
Employee Job
Training File
Security
Pest Control
Q037
Q028
Q029
QS001
BNL Contracts
O_M Procedures
Preparation
Quality Policy
Red Hot Cell Diagram, D001 and
Red Hot Cell Process, D002
Q021, C020, Q005, Q038, Q004,
Q002, Q010, Q013, Q027
Production Framework
Diagram, D004
Production Framework
Diagram, D004
Pre- and Post-Release Testing
Diagram, D004
Pre- and Post-Release Testing
Diagram, D004
Q022
CA001-CA005
W001
Package and
Shipping
A005
Specific Activity Q015
Release
Q033
Training Matrix
Master Equipment List
Master Document List
Internal Audit Form
Name/Signature Form
CAPA Form Problem Reporting/CA
Q002, Q011, Q013, Q018, Q020,
Q021Q026, Q031, Q032, Q034,
Q035, Q044,
Radiopharmaceutical
Production


Quality Manual
Contents
Purpose of the Quality
Manual
Contents of the Quality
Manual
Relationship of the
Quality Manual to the
Validation Master Plan
Examples of Quality
Manuals
STOP
Example of a Quality Manual

Another example of a Quality Manual with less detail but
covering the major elements can be found by following the
arrow.
Quality Manual Example More
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