OQ Template Sample

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OPERATIONAL QUALIFICATION PROTOCOL FOR [NAME HERE] Your Logo

Protocol Approval

Document Title: (further description here)

Print Name

Signature

Date

Print Name

Signature

Date

Production Engineering R&D Regulatory Affairs Quality Assurance

Execution Approval Production Engineering R&D Regulatory Affairs Quality Assurance

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Introduction Add an Introduction of the Validation Here

Brief System Description and OQ Rationale 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 Your company “Validation Policy – Validation Master Plan.

Scope This protocol covers the Installation Qualification 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 OQ. The OQ execution shall be reviewed and approved prior to execution of the PQ. Upon completion of the PQ, a final review will be done and sign off.

Objectives The objectives of this Operational Qualification (OQ) protocol is to ensure that the [Name Process Here] operates retrospectively, prospectively, concurrently [delete as appropriate] 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 IQ activities. At a minimum, the following are prerequisites.

The IQ protocol must be approved and executed and then reviewed for approval.

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 OQ must be within its calibration frequency.

Protocol Number: : (add assigned no.)

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Test OQ# – Cleaning Verification Objective

To ensure that the [name equipment here] and change parts are cleaned down adequately 1. Document below any Cleaning SOP reference no.’s and issue no.’s relating to the [name equipment here] and check for accuracy

Method

2. Clean down the [name equipment here] as per normal and document any results

SOP No.

Issue No.

Adequate –Yes /No (If No add comment)

Results

Cleaning should remove any active bacteria or microorganisms Acceptance Criteria

Acceptance met

criteria

YES / NO – If NO, record Concession number in comments box

Comments / reference to attachments

Protocol Number: : (add assigned no.)

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Test OQ# – SOP Review Objective

The objective of this test is to review the existing SOPs related to [name equipment here] for adequacy 3. Document below all SOP reference no.’s and issue no.’s relating to the [name equipment here] and check for accuracy:

Method

SOP No.

Issue No.

Adequate –Yes /No (If No add comment)

All SOPs should be accurate and reflect process Acceptance Criteria

Acceptance met

criteria

YES / NO – If NO, record Concession number in comments box

Comments / reference to attachments

Protocol Number: : (add assigned no.)

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