INSTALLATION and OPERATIONAL QUALIFICATION PROTOCOL IOQ for Bottle Unscrambler Ref: XX
Rev: 1
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IOQ PROTOCOL AUTHORISATION Name/Title
Signature
Date
Signature
Date
Prepared by Reviewed by Reviewed by Reviewed by
Reviewed by
IOQ PROTOCOL REPORT AUTHORISATION Name/Title Reviewed by Reviewed by Reviewed by
Reviewed by
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Introduction The BOTTLE Unscrambler machine on Line XX will be validated to GMP, MHRA Annex 15.
Brief System Description and IOQ Rationale The BOTTLE Unscrambler and Air rinse system will be challenged in this protocol. Randomly oriented bottles are received in bulk into the hopper and supplied to the centrifugal disc by means of a conveyor. In the disc, the bottles are guided into a qualified position (e.g. single stream, either neck leading or base leading) suitable for the stand up unit to process them into the required discharge position (e.g. standing, horizontal, neck leading). Symmetrical bottles are stabilised and released on the customer conveyor. The centrifugal disc receives bottles in random orientation from the hopper and by means of centrifugal action, guides the bottles into a groove on the outer edge of the disc. From this groove bottles are fed into the stand up unit. The Air flow is directed to ensure there are no contaminants in the bottles prior to filling. It is imperative recommendations.
that
checks
are
thoroughly
documented
according
cGMP
Scope This protocol covers the Installation & Operational Qualification for the BOTTLE Unscrambler on Line XX. 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 BOTTLE Unscrambler on Line XX has been installed and operates retrospectively and is fit for use in accordance with cGMP and Health and Safety requirements.
Protocol Number: VP-PR-IQ-001 Page 22 of 15
Version 01
Index of IOQ for the BOTTLE Unscrambler on Line XX Test Reference
Test Name
IQ Section 1
Description and Reference Numbers
2
Mechanical, Electrical Checks
3
Critical Components
4
Maintenance and Calibration Checks
5
Availability of Software
6
Documentation Review
7
Health and Safety Checklist
8
cGMP Audit IQ Sign Off
OQ tests for execution 1
Hopper level Sensor
2
Hopper to Centrifugal Disc Check
3
Backup Sensor
4
Containers move in an Upright Position
5
Antistatic Removal
6
Product Challenge
7
Exit the Unscrambler
8
SOP Review
9
Training
10
Cleaning Verification
Protocol Number: VP-PR-IQ-001 Page 32 of 15
Version 01