Validation – Tablet Filler/Counter Tablet Filler/Counter 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
Page No 1 of 7
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
IOQ for Tablet Filler Counter
Asset No. XXXXx
Introduction The Tablet Filler Counter/Counter 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 Tablet Filler/Counting Machine is suitable for counting all types of tablets and capsules. It is manufactured to easy clean GMP standards. A sanitary conveyor is fitted as standard with stainless steel guide rails and plastic slats. A hopper is fitted at the rear of the machine for the bulk tablet supply. Vibrators are fitted beneath the slats to settle tablets into the slat cavities as they move towards the top of the machine. A top rotary brush ensures that dust, broken tablets or “doubled up” tablets are wiped away before the slats release the tablets into the funnels. A clear Perspex panel allows visual inspection of the filled slats as they move down. A ten drop shutter is fitted as standard and it is below this that the funnel changepart is located. This is made of polished stainless steel and made to suit each container diameter to be handled. The controls of the machine are all housed in one control box. All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according to cGMP recommendations. All testing will be performed retrospectively, and all tests will be in accordance with Your Company Name “Your SOP Here”.
Scope This protocol covers the Installation & Operational Qualification for the Tablet Filler Counter counter 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 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 Tablet Filler Counter counter on Location Here has been installed and operates retrospectively 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: : XXXXXXX Page 2 of 2
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