Slide 1

Radiopharmaceutical ProductionQuality ManualSTOP1Contents of the Quality ManualThe following are examples of sections that a Quality Manual should contain:Table of Contents Introduction Facility BackgroundPurposeScopeQuality 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 ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP5Contents of the Quality ManualBackground: 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 ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP6Contents of the Quality ManualQuality 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 performExample: 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 ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP7Purpose of the Quality ManualThe organization should establish and maintain a quality manual that includesthe quality policythe scope of the quality management system, including details of and justification for any exclusionsthe documented procedures established for the quality management system, or reference to them, anda description of the interaction between the processes of the quality management system.

Radiopharmaceutical Production

Quality ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP3Contents of the Quality ManualA 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 ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP4Relationship of the Quality Manual to the Validation Master PlanQuality 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 ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP12Example of a Quality Manual

Radiopharmaceutical Production

Quality ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP14Example of a Quality ManualOne 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 ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP13Example of a Quality ManualAnother example of a Quality Manual with less detail but covering the major elements can be found by following the arrow.Quality Manual ExampleMoreRadiopharmaceutical Production

Quality ManualContentsPurpose of the Quality ManualContents of the Quality ManualRelationship of the Quality Manual to the Validation Master PlanExamples of Quality ManualsSTOP15Return to Main Menu16