IOPQ Freezer Validation Template - Sample

INSTALLATION, OPERATIONAL and PERFORMANCE QUALIFICATION PROTOCOL Installation, Operational, Performance Qualification of the [name freezer with location here]

Validation No.XX and Asset No.XX Name your site here

Ref: XXXX

Rev: 1

Page No 1 of 4

Protocol Approval Name Author

Responsible Your Name

Signature

Date

Signature

Date

QA Sign Off Production Sign off Regulatory Affairs Sign off (if applicable)* Engineering Sign off

Protocol Execution Approval Name Author

Responsible Your Name QA Sign Off Production Sign off Regulatory Affairs Sign off (if applicable)* Engineering Sign off

*Please follow notes for sign off applicability with specific reference to regulatory affairs

Page 1 of 4

[Description here]

[Asset Number/s Here]

Introduction The validation document within is a combined Prospective Installation, Operational and Performance Qualification for the [name the fridge/freezers] in the [name the location] of the Your site site.[include a brief introduction of the history of the fridge/freezers here].

Brief System Description and IOPQ Rationale There are currently [name the number of fridge/ freezers here with the Asset numbers] in situation in the [name location here] ready for validation.

[Write a brief paragraph explaining the freezer history, its uses, performance (check Maintenance System for breakdown/maintenance and calibration history)].

There will be a minimal IQ, OQ will involve empty and loaded chamber testing, while it has been decided that a PQ rationale will be written based on the OQ temperature mapping exercise, this will be based on similar results of mapping to ASSET Number (XXXX).

Scope This protocol covers the Installation, Operational and Performance Qualification (Combined) for the [name the freezer here with Asset number]. 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 IOPQ. The IOPQ execution shall be reviewed and approved prior to summary write up. Upon completion of the IOPQ, a final review will be done and signed off.

Objectives The objectives of this Installation, Operational and Performance Qualification (IOPQ) protocol is to ensure that the [name the freezers here] have been installed and operates prospectively and is fit for use in accordance with cGMP and Health and Safety requirements. The objective of the freezers is to store [name the products stored and its uses here]. The purpose of the validation exercise will be to ensure Protocol Number: : XX-IOPQ-XX Page 2 of 4

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[Description here]

[Asset Number/s Here]

suitability of the freezers as well as to highlight the areas which are hotter and colder to ensure there are no out of limits spots which could jeopardise the storage conditions of the product and to avoid the storage in these spots.

Pre-requisites The following must have been executed, been completed and approved prior to commencing the IOPQ activities.

•The process must be listed on the Validation Timeline.

•The process must be deemed to require Validation and be documented on the Validation Plan.

•

Protocol Number: : XX-IOPQ-XX Page 3 of 4

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[Description here]

[ASSET Number/s Here]

Fig 1.0 Empty Chamber [amend diagram as necessary – and place stars in correct locations of log tag positions. – 6 in total] FAN

FAN

Built in probe

Protocol Number: : XX-IOPQ-XX Page 4 of 4

Version 1.0