Department | Validation/Technical Services | Document no | VAL-205 | ||
Prepared by: |
| Date: |
| Supersedes: |
|
Checked by: |
| Date: |
| Date Issued: |
|
Approved by: |
| Date: |
| Review Date: |
|
A. APPLICATION
To outline the procedure for the management of validation related projects and documentation.
B. RESPONSIBILITITY AND AUTHORITY
1. It is the responsibility of the Validation Department to assign a project number to the validation project and to ensure that the progress of the project is kept up to date in the Validation Database.
2. It is the responsibility of individual personnel (from outside the Validation Department) in charge of a project which requires validation to work in collaboration with the Validation Department on the generation of validation documents.
3. It is the responsibility of the Validation Department to provide guidance on the validation requirement of any given project.
4. In the case where the expertise of a vendor, contractor or consultant is engaged, it is the responsibility of the Validation Department to ensure that all validation documents are prepared according to GMP site’s standards and procedures.
C. SAFETY AND PROCESS SPECIFIC INFORMATION
N/A
D. PROCEDURE
1. Validation Project Numbers
1.1 When a new validation project is initiated, a validation project number is assigned to the project as follows:
1.2 The validation project identification takes the form of a six-digit number:
AA-B-CCC.
Where:
AA = Denotes the last two digits of the year in which the project is initiated/registered, i.e. 11 for 2011.
B = Denotes an automatically generated number. This number has no meaning at this stage
CCC = Denotes sequential number for each year, starting from 001.
2. Registration in Validation Database
2.1 The validation database is used to maintain a record of the work undertaken for the purpose of validation and the current validated state of a process (product), equipment or system.
2.2 The Validation database has two main sections the first section is the “Validation” section which contains details of the physical equipment, system or process that requires validation. The second section is the “Project” section which contains details of the activities undertaken to demonstrate a valid state. A valid state is considered to be the sum of all projects that are undertaken to demonstrate a “Validation Item” has met defined validation requirements.
3. Validation Item
3.1 A new validation item is entered into the database as “New Validation”.
3.2 Each validation record should have the following validation attributes.
Validation Number (Val No.) – The validation number is not automatically generated but must be unique. The validation number is the accepted unique identifier for the item requiring validation. The number may be the equipment number such as “PU101” for a pump or “SIXE” for a product.
Description – This is the accepted name of the item such as “Blending Tank BT01” or “Panadine Oral”. In some cases, the description and validation number may be used to define a validation specific group such as a tank group or product group.
Area – The area of the validation item refers to the location or owner of the system.
Group – Validation items are grouped into item related classes such as “Equipment and Systems” for a purified water plant or mixing vessel.
Type – The type attribute of the item is a sub group of the main group such as “Vessel” for a mixing or blending tank.
VMS – This item is selected if the item is active and is an item that has a GMP impact.
Risk – The risk level relates to either a formal assessment undertaken (See VAL 185) or to that of a more superficial assignment. The nature of risk(s) posed should be continually assessed.
Revalidation – This section is completed to indicate the date at which any revalidation activities must be conducted.
3.3 The Validation Life Cycle is updated at the completion of each associated project. The “Life Cycle” section shows the current validated state of the item and those activities that are currently in progress or requiring undertaking.
3.4 The associated project section of the database is added automatically from the project section (See Section 4).
3.5 A comment section at the base of the form is used to provide any further information not previously recorded.
4. Project Item
4.1 The second section of the database is the project section. The project section maintains a record of the projects and activities that are undertaken to demonstrate the valid state of a “Validation item”.
4.2 To enter a new project open the Validation Database
4.3 Select new project from the project list and a new project number is generated.
Record the following information in the project panel:
Project Number – Automatically generated
Description – The description field is the project title and should describe the element and type of validation. This field is used to search and display projects.
Start Date – The day the project will commence
Target Date – The day the project is due to be completed
Completion Date – The day the project was closed, this is usually the date the report was signed off.
Priority Driver – The priority driver is used to define why a project was undertaken, the importance and link to other GMP activities. For example, if the project was undertaken as a result of change control than “Change Control” (CC) should be selected and the CC number added to the reference section (below).
Project Manager – The person who is the project leader and responsible for coordinating the completion of all activities. Where the person selected is a member of the Validation team the project will show up in the “My Projects” section.
Risk Level – The risk level relates to either a formal assessment undertaken (See SOP VAL 185) or to that of a more superficial assignment. As the project progresses the nature of risk of the project should be continually assessed.
Life Cycle – The life cycle option refers to the stage in the life cycle the “Validation Item” is in whilst this project was undertaken. Therefore, the creation of a URS project for a new piece of equipment would be the “Development and Design” stage (See Validation Master Plan VAL 080 for Life Cycle definition).
Validation Area – Validation Area or type refers to the type of validation project being undertaken and is used in the Master Plan report to group similar projects.
Project Type – Project type refers to the type of protocol that will be created to document this project.
Commitment – The commitment attribute of project indicates the group driving the requirement for the project. Where the group is a regulatory body the activity may have been undertaken to meet an audit observation.
Reference – The reference attribute is used to refer a project to a source event such as a change control or audit observation.
4.4 In the Project database record information in the “Project Scope” area to define the scope and activities that were undertaken and any other associated equipment(s) or project(s).
4.5 When a new project has been created and the required information has been entered the project needs to be assigned to a “Validation Item” (See Section 3).
4.6 Once the project item has been set up in the database, enter the dates for each project stage.
4.7 Trace the progress of the project by adding notes progressively.
5. Preparation of Validation Documents
5.1 A validation protocol is written for each project. It normally includes the following elements:
– Approval,
– Objective,
– Scope,
– Responsibilities,
– Background,
– Validation Rationale,
– Testing and Methodology,
– A list of the required validated test methods with the corresponding validation report numbers
– Acceptance criteria,
– Deviation form
– Interim form
– Signatories form
5.2 A protocol cannot be executed until it is approved by the relevant management representatives.
5.3 When the protocol has been executed, a validation report documenting the results from the validation activity shall be prepared.
5.4 The validation report shall include the following elements:
– Approval list (including final sign-off),
– Purpose and Scope,
– Introduction and Summary,
– References,
– Conditions of Validation,
– List of Equipment used,
– Description of validated procedure or process,
– Critical Control Criteria and Validation parameters,
– Results of the validation testing,
– Discussion of results of the validation tests relative to the acceptance criteria, including a description and resolution status of protocol deviations (if any),
– List of Deviations (from the protocol),
– Final conclusion to the validation activity,
– Any recommendations,
– Attachments Index,
– Appendices (e.g. acronyms and abbreviations),
– Attachments (any data generated while the validation was performed).
5.5 The report must clearly define in regards to the validated process, the process equipment used, batch sizes and critical variables or parameters such as temperature and mixing speed etc.
5.6 The recommendation section should clearly state the elements of the validation that must be recorded in manufacturing records or procedures. Where a procedure is updated a reference to the associated validation should be made.
5.7 The summary report, together with the executed protocol, shall be circulated for approval to those individuals identified in the “Approval” section of the report. These are generally the same individuals who approved the protocol.
5.8 At each stage of the document flow, the database is updated accordingly
5.9 At the end of the document flow, scan the approved documentation and place in the relevant validation folder.
6. Review and Approval of Validation Documents
6.1 Validation documents (both protocol and reports) are to be circulated for review and approval to those individuals identified in the “Approval” section of the protocol using the review/approve procedure for validation documents Appendix 1 form for each copy issued to be reviewed.
6.2 Reviewers are generally the managers of departments that have responsibilities identified or implied in the protocol. This may also include personnel involved in the validation process.
6.3 Signing the Protocol signifies:
– Agreement that the proposed validation rationale and method are appropriate,
– Agreement that the proposed acceptance criteria are appropriate,
– Agreement that the proposed qualification activity complies with the corporate and regulatory requirement,
– Agreement that the information in the background is correct, and
– Acceptance of the proposed responsibilities.
6.4 Signing the Report signifies:
– Agreement on the content and completeness of the report,
– Agreement that any proposed recommendations are appropriate based on the information in the summary report,
– Agreement that any operational implications of the proposed recommendations are reasonable, and
– Acceptance of any proposed plan for ongoing validation.
6.5 A validation document is only approved when all parties included on the approvals list have signed in the Approval section of the document (including final approval).
6.6 Uncontrolled copies of the validation documents may be made available to personnel upon request to the Validation Department. These copies shall be clearly marked “Uncontrolled document – destroy after use”.
7. Amendments
7.1 For documents being circulated as draft for reviewing there is no need to document the amendment(s). Where improvements/alterations to the validation documents have been suggested or if there are questions raised about certain aspects of the validation documents, it is up to the document author to review and make alterations if necessary, and to ensure that all issues are resolved in a timely manner.
7.2 Where amendment(s) to the validation documents are required after final sign off (prior to the validation being conducted), the document author shall clearly document the amendment(s) in the ‘Validation Document Amendment’ form (see Appendix 2) with the reason for revision given.
7.3 Those signatories originally approved the validation document shall approve the ‘Validation Document Amendment’ form. The amendment(s) can then be made to the validation document and this form is to become part of the validation document package.
7.4 Any changes/deviations to a validation procedure (as documented) which occur during the execution of the validation outlined are to be recorded by completing a Deviation form, either as part of the protocol or in the company’s deviation system.
Appendix 1: Review / Approve Procedure for Validation Documents
Appendix 2: Validation Protocol Amendment