INSTALLATION, OPERATIONAL and PERFORMANCE QUALIFICATION PROTOCOL Installation, Operational Qualification of the Homogeniser Machine [details with location here]
Validation No.XX and Asset No.XX Your Site Here
Ref: XXXX
Rev: 1
Page No 1 of 3
IOQ PROTOCOL AUTHORISATION Name/Title
Signature
Date
Signature
Date
Prepared by Reviewed by Reviewed by Reviewed by
IOQ PROTOCOL REPORT AUTHORISATION Name/Title Reviewed by Reviewed by Reviewed by
Page 1 of 3
IOQ Protocol In Line Shearer/Homogeniser Mixer
Introduction The In Line Shearer/Homogeniser Mixer will be validated. This IOQ will cover the Prospective validation of the system and its components to GMP, MHRA Annex 15.
Brief System Description and IOQ Rationale This validation is to bring in line with current documentation to ensure compliance with cGMP. The In Line Shearer/Homogeniser mixer is a critical process to product quality. The integrity of the In Line Shearer/Homogeniser mixer can affect process and product risk if this is compromised. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations.
All testing will be performed Prospectively since there is no historical data since its installation, and all tests will be in accordance with company standards.
Scope This protocol covers the Installation & Operational Qualification for the Liquid Manufacture In Line Shearer/Homogeniser Mixer. 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 IQ execution shall be reviewed and approved prior to execution of the OQ. Upon completion of the OQ, a final review will be done and sign off.
Objectives The objectives of this Installation & Operational Qualification (IOQ) protocol is to ensure that the In Line Shearer/Homogeniser Mixer has been installed and operates prospectively and is fit for use in accordance with cGMP and Health and Safety requirements.
Protocol Number: : VP-XX-IOQ-XX Page 2 of 3
Version 1.0
IOQ Protocol In Line Shearer/Homogeniser Mixer
Index of IOQ Protocols for the In Line Shearer/Homogeniser Mixer Test Reference
Test Name
IQ Section 1
Description and Reference Numbers
2
Mechanical, Electrical and P&ID Checks
3
Valve check
4
Control Checks for Proximity Switches/ E Stops
5
HMI Check
6
Material certification check
7
Documentation Review
8
Maintenance and Calibration Review
9
Availability of Software
10
cGMP Audit IQ Sign Off
OQ tests for execution 1
Particle Size Checks
2
Clean in Place Checks
3
Training OQ Sign off
Protocol Number: : VP-XX-IOQ-XX Page 3 of 3
Version 1.0