Reference your document here
Written By:
Other references
Revision: 01
Date
INSTALLATION, OPERATIONAL VALIDATION PROTOCOL FOR [NAME HERE]
Your Logo
Protocol Approval
Page 1 of 7
Document Title: (further description here)
Print Name
Signature
Date
Print Name
Signature
Date
Production Engineering R&D Regulatory Affairs Quality Assurance
Executionl Approval Production Engineering R&D Regulatory Affairs Quality Assurance
Page 1 of 7
Reference your document here
Written By:
Other references
Revision: 01
Date
Page 2 of 7
VALIDATION PROTOCOL Your Logo
Document Title: (describe here)
Introduction Add an Introduction of the Validation Here
Brief System Description and IOQ Rationale [Describe the System and add a rationale for using the IOQ approach] All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations. All testing will be performed retrospectively, prospectively, concurrently (delete as appropriate), and all tests will be in accordance with Pharmi Med “Validation Policy – Validation Master Plan.
Scope This protocol covers the Installation, Operational Qualification (Combined) for the [Name Process Here]. The scope of this document is therefore limited to the testing for the equipment related to this and to assure that equipment is fit for use in accordance with cGMP. The protocol shall be reviewed and authorised by the stated personnel in the approval box prior to execution of IOQ. The IOQ execution shall be reviewed and approved prior to summary write up. Upon completion of the IOQ, a final review will be done and signed off.
Objectives The objectives of this Installation, Operational Qualification (IOQ) protocol is to ensure that the [ Name Process Here ] has been installed and operates retrospectively and is fit for use in accordance with cGMP and Health and Safety requirements.
Pre-requisites Identify activities and tasks that must have been executed, been completed and approved prior to commencing the IOQ activities. At a minimum, the following are prerequisites. •The process must be listed on the Validation Timeline. •The process must be deemed to require Validation and be documented on the Validation Plan. •The VP Deliverables checklist must be prepared. •The VMP document must be written and approved.
Version 1.0 Page 2 of 7
Reference your document here
Written By:
Other references
Revision: 01
Date
Page 3 of 7
VALIDATION PROTOCOL Your Logo
Document Title: (describe here)
•The ‘Pre-requisites to Validation Activities’ Stage Deliverables (identified on the VP Deliverables Checklist) must be completed and approved, or at least ongoing with scheduled target dates and the responsible person identified. •The IOQ Checklist Charts must be prepared, using data/documentation from the ‘Prerequisites to Validation Activities’ stage. Product predetermined specifications and quality attributes must be established and documented. Test method and measurement systems must be established and qualified. Calibration of test equipment and instrumentation used during the IOQ must be within its calibration frequency. Batches used for the IOQ must be identified in a manner that prevents unintentional release of product.
Report Upon completion of the IOQ protocol the findings must be summarised in a collective IQ/OQ Summary Report. The following must be reported within the summary: Any corrective actions identified during the execution of this protocol have been deemed not to impact on the IOQ, and have been completed and approved. Any non-conformances identified during the execution of the protocol have been investigated and deemed not to impact on the validation status. Any deviations to the protocol, specification or requirements have been investigated and evaluated, and deemed not to have an impact on the validation status. Supporting Data/Documentation is referenced for traceability. Where documented evidence is to remain with the Validation package, this is adequately labelled/identifiable, as well as signed and dated by the person responsible.
Version 1.0 Page 3 of 7
Reference your document here
Written By:
Other references
Revision: 01
Date
Page 4 of 7
VALIDATION PROTOCOL Your Logo
Document Title: (describe here)
Version 1.0 Page 4 of 7
Reference your document here
Written By:
Other references
Revision: 01
Date
Page 5 of 7
VALIDATION PROTOCOL Your Logo
Document Title: (describe here)
Operational Qualification The OQ must only commence with the satisfactory completion of IQ. Add a brief summary of the OQ here.
Operational Functional Tests [add/remove rows as applicable] Product Range Selected …………………………………………………………………. Test Summary (detail the tests here and add a summary where appropriate) Start Machine as normal, following user manual and perform the following function checks:
Test No. OQ1
Test Description
Acceptance Criteria
OQ# OQ# OQ#
Version 1.0 Page 5 of 7
Pass/Fail
Initial/ Date
Reference your document here
Written By:
Other references
Revision: 01
Date
VALIDATION PROTOCOL Your Logo
Document Title: (describe here)
OQ#
Acceptance met
YES / NO – If NO, record Concession number: ……………………..
criteria
Completed By Sign
Date
Sign
Date
Verified By
Version 1.0 Page 6 of 7
Page 6 of 7
Reference your document here
Written By:
Other references
Revision: 01
Date
Page 7 of 7
VALIDATION PROTOCOL Your Logo
Document Title: (describe here)
DEVIATION LIST Concession Number
Concession/Deviation Description
Responsibility For Completion
Expected Completion Date
Production Manager (Signature): .............……….
Name (Printed): ......….................….
Date: ..............
Quality Manager (Signature): ...........……….......
Version 1.0 Page 7 of 7
Name (Printed): ...…...................…..
Date: ..............