Validation – Checkweigher Checkweigher for [name system/equipment here] XX(area)-IOQ (Installation and Operational Qualification)XXX(unique project number) Add Your Site Here
Ref: Val_________
Rev/Issue: 1
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IOQ PROTOCOL AUTHORISATION Name/Title Prepared by
Your Name
Reviewed by
Quality Assurance
Reviewed by Reviewed by
Engineering Regulatory (If required)
Reviewed by
Other
Signature
Date
Signature
Date
IOQ PROTOCOL REPORT AUTHORISATION Name/Title Reviewed by
Quality Assurance
Reviewed by Reviewed by
Engineering Regulatory (If required)
Reviewed by
Other
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IOQ for Checkweigher
Asset No. XXXXX
Introduction The IOQ for XXX Checkweigher on (Location Here) will be retrospectively validated and has been running historically with production history and data. This IOQ will cover the retrospective validation of the system and its components to GMP, MHRA Annex 15.
Brief System Description and IOQ Rationale The Metter Toledo Garvens on (Location Here) is a combi checkweigher and metal detector. However they will be validated separately. The XS3 CC checkweigher is suitable for dynamically weighing products up to 6000g with accuracy from ± 0,1g and a maximum throughput of 400 ppm. The checkweighing function is performed using a fully functional and globally proven GARVENS XS3 checkweigher. This ensures highly accurate dynamic weight measurement with an accuracy of ±0.1 g. The checkweigher measures product weights quickly and precisely, rejecting "out of tolerance" products. The industry proven, modular design can be enhanced with the full range of software options and accessories available. This allows you to tailor the checkweigher to your specific application requirements. It is particularly service friendly, cutting maintenance time to an absolute minimum and significantly reducing downtime. 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, and all tests will be in accordance with “Your SOP Here”
Scope This protocol covers the Installation and Operational Qualification for the Mettler Toledo Garvens Checkweigher on (Location 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 OPQ. 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 Installation and Operational Qualification (IOQ) protocol is to ensure that the Mettler Toledo Garvens CheckWeigher on (Location Here) operates retrospectively, repeatedly and reliably and is fit for use in accordance with cGMP and Health and Safety requirements. Statistical Sampling Plan Ensure all samples removed for testing are relevant to a statistical approach using ISO/BSI or ANSI Standard. Attribute testing will either be in line with ISO2859 or ANSI Z1.4, Variable testing will be in line with ISO3951or ANSI Z1.9.
Protocol Number: : XXXXXXXX Page 2 of 3
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IOQ for Checkweigher
Asset No. XXXXX
Add a rationale for the use of AQL and sampling level, this may be due to historical reasons but needs to be justified by – 1. 2. 3.
Complaint History Equipment History and records Any other reason
Protocol Number: : XXXXXXXX Page 3 of 3
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