Validation Plan

TEM055 Issue date

Validation Plan

(Ref.VAL005)

Project Name
Project Number
Equipment
Serial Number
Manufacturer
Model Number
Process Line/Location
Protocol number

PROGRAM INDEX OBJECTIVE.......................................................................................................................................2 DESCRIPTION OF EQUIPMENT / PROCESS / SYSTEM.............................................................................2 DESIGN QUALIFICATION ....................................................................................................................2 LIST OF SYSTEMS / PROCESS SUBPARTS TO BE VALIDATED................................................................2 INSTALLATION QUALIFICATION DOCUMENTATION................................................................................2 COMPUTER VALIDATION ....................................................................................................................3 CLEANING VALIDATION .....................................................................................................................3 OPERATIONAL QUALIFICATION TEST PLAN AND ACCEPTANCE CRITERIA..............................................3 REQUIRED STANDARD OPERATING PROCEDURES ( SOPS) .................................................................3 TRAINING..........................................................................................................................................4 PROJECTED TIMELINE .......................................................................................................................4 PERFORMANCE QUALIFICATION PHASE..............................................................................................5 CHANGE CONTROL ...........................................................................................................................5 RESPONSIBILITIES.............................................................................................................................5


Validation Plan Prepared By:
Position Name Signature Date
Project Coordinator



APPROVAL OF THE VALIDATION PLAN
Position Name Signature Date
Validation Manager


Quality Assurance Manager


Operations Manager


Additional approval that may be required depending on the size and importance of the project.

TEM055 Issue date

Validation Plan

(Ref.VAL005)

IQ based on Demand Specifications Applicable to this Project*
1. Equipment Functional Demand Specification Yes/No
2. Mechanical / Design Specification Yes/No
3. Electrical Demand Specification Yes/No
4. Instrumentation Demand Specification Yes/No
5. Operator’s Control Panel Specification Yes/No
7. Technical Documentation Specification Yes/No
8. Environmental, Health and Safety Requirements Yes/No

Computer Validation Impact Assessment on the product Quality is to be conducted for the proposed project. Justify any computer validation activities in the plan being under taken by this project. Any Operational Qualification testing required as part of the validation requirement is to be included.

Cleaning Validation

Cleaning Validation is to be conducted in accordance with the requirements of SOP VAL020.

Cleaning Validation required for the process, equipment or procedures. Yes /No
Select the Worst Case Product for Cleaning according to SOP VAL020
Analytical Method Validation required for Worst Case Product Yes / No
Is analytical method validation complete? Yes / No
Include reference file for analytical method validation report.

Any Operational Qualification testing required as part of the validation requirement is to be included in the plan.

Operational Qualification Test Plan and Acceptance Criteria

Validation activities are to be conducted in accordance with the requirements of SOP VAL005.

All documentation is to follow the requirements stipulated in SOP VAL005. Templates for the various documents are to be sourced from the Templates.

List of Operational Qualification tests that are to be conducted.

The acceptance criteria for the operational qualification tests should be clear and unambiguous so that review and approval of the final qualification reports is expedited.

It may be more appropriate to separately record the Operational Qualification Tests and the Acceptance Criteria for each test. In which case include a separate section in the plan for the Acceptance Criteria and update the Program Index.

Required Standard Operating Procedures ( SOPs)

Include the full SOP no. Ensure you reference the current version. Relevant SOPs required to conduct the validation activities are to be listed.

TEM055 Issue date

Validation Plan

(Ref.VAL005)

Performance Qualification Phase

Fill in details

The Performance Qualification will consist of plus any additional tests determined to be necessary during the Operational Qualification phase.

Change Control

The Change Control Procedure according to SOP QMS030 will be enacted after the commencement of the Operational Qualification phase of this project.

Responsibilities

List of personnel who have been allocated as resources for the validation project and their individual responsibilities.

NB the understanding and acceptance of the personnel listed must be obtained in advance.


Activity Position
1. Validation Plan Prepared by: Authorised by: Project Coordinator Validation Manager Quality Assurance Manager Operations Manager
2. Training needs assessment
3. Modifying current SOP’s Writing required SOP’s,
4. Preparation of Installation Qualification Reports for approval to execute. Prepared by: Checked by: Authorised by: QA or Validation Manager
5. Review of completed IQ Report Prepared by: Checked by: Authorised by: Electrical Mechanical Project Coordinator Validation Manager Quality Assurance Manager Operations Manager
6. Writing Operational Qualification Test Protocols Prepared by: Checked by: Authorised by: QA or Validation Manager
7. Conducting OQ tests
8. Completed OQ Test Protocols Documented by: Checked by: Approved by: QA or Validation Manager


TEM055


Issue date

Validation Plan

(Ref.VAL005)
Document Revision History

Revision # Date Reason for Revision Author Initial for Retrieval of Outdated Documents




















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