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Validation – Capping Machine Capping Machine [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

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Date

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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 Capper

Asset No. XXXXXX

Introduction The IOQ for the XXXX Capper on XXXX 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 Capper on XXX is a XXXX with 8 capping heads and applies caps at a rate of up to XXX/min (enter speed). The caps are correctly orientated by a vibratory bowl unit and appropriate inserts. They are fed along a chute to the cap starwheel at which point they are fed around to the cap pick up position. The caps are picked up in turn by each of the capping heads which then descend to screw the caps onto the containers. The containers travel along a conveyor and then enter a scroll drive which pre-spaces the containers prior to being fed into the infeed starwheel. A set of backplates or a gripper belt arrangement are used to guide the containers through the machine. After capping the containers are fed into an outfeed starwheel and back on to the conveyor. A No Bottle Switch is used on the conveyor infeed which will stop the machine if the conveyor supply runs out. A Back Up switch is used on the conveyor outfeed which will stop the machine if containers build up from the next machine on the line.

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 “XXXXX enter your SOP here�.

Scope This protocol covers the Installation and Operational Qualification for the XXXX (name Model here) Capper on XXX (name the line here). The scope of this document is therefore limited to the Protocol Number: : XXXXXX Page 2 of 3

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IOQ for Capper Asset No. XXXXXX 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 PQ. 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 and Operational Qualification (IOQ) protocol is to ensure that the Capper on (name line 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. 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: : XXXXXX Page 3 of 3

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Capper IOQ Template Sample