Validation – Blister Machine Blister Packaging 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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Introduction The Blister Packaging Machine on ................... 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 or list other notified body here.
Brief System Description and IOQ Rationale The XXXX Blister Packing Machine (...................) contains direct product contact parts and so it is deemed necessary to complete a process of validation for the equipment. Failure of this item of equipment would result in an inability to operate the packaging line and therefore a full cessation of production operations on this line. The XXXXXXX blister-packing machine includes material infeed of blister forming items (foil & film), product infeed via an automated hopper unit (capsules or tablets) and blister forming using heated surfaces. It shall therefore be necessary to identify that all infeed sections operate suitably and that heating conditions for blister forming are suitable for creating an acceptable blister strip in accordance with the product specification and QA assessment.
All systems shall not be challenged in this protocol since a previous validation was done in 2??? Enter year here. This validation protocol shall challenge the machine with additional integrity tests described in the following sections. The validation shall also be reviewed against current GMP standards. All testing will be performed retrospectively, and all tests will be in accordance with ................... “enter your procedure here�.
Scope This protocol covers the Installation & Operational Qualification for the Blister Packaging on .................... 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.
Protocol Number: XXXXX Page 22 of 15
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