IOQ for Tablet Counter Sample

INSTALLATION and OPERATIONAL QUALIFICATION PROTOCOL IOQ for Tablet Counter Ref: XX

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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 tablet and capsule counting machine on Line XX will be validated to GMP, MHRA Annex 15.

Brief System Description and IOQ Rationale The is a high speed electro mechanical counting machine suitable for use with compressed tablets, and soft gelatine capsules. A set of slats are carried on a pair of chains which run under a hopper, tablets flow into the slat pockets and are electro/mechanically vibrated to assist loading and to control the flow as they move towards the top of the machine.

The slats now pass under a rotating brush, which knocks back surplus tablets after which they pass down the front of a machine into the visual inspection area. The slats then pass through the shutter assembly where the tablets fall out of the pocket aided if necessary by a pneumatic thumper, and down through a funnel and into the containers.

Each container receives the amount of tablets required which is governed by the set up of the pre-determined slat pattern.

The machine sequence is governed by a sensor on the right hand side of the machine, which is activated by slats with strikers, which signals the containers to be gated. Gating cylinders, or a scroll control the movement of the containers on the conveyor. With the conveyor running the gating cylinders or scroll present a set of containers under the funnel, holding them in a position until filled, then gating them away. There are sensors fitted to the machine detecting “no bottles” and “backed up bottles”. All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according to cGMP recommendations.

Scope This protocol covers the Installation & Operational Qualification for the tablet filler counter 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 tablet/capsule counter/ filler on Line XX has been installed and operates retrospectively and is fit for use in accordance with cGMP and Health and Safety requirements.

Index of IOQ Tablet/ Capsule Fillers Line XX Test

Test Name

Protocol Number: VP-PR-IQ-001 Page 22 of 15

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Reference 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

Sensors Checl

2

Challenge Vibrator Speed for Track

3

Lower Slat Vibrator Challenge

4

Upper Slat Vibrator Challenge

5

Challenge Conveyor Speed

6

Challenge Set/Auto/ Hand Modes

7

Challenge Head Speed

8

Challenge Brush Motor

9

Product Challenge

10

Cleaning Verification

11

SOP Review

12

Training

Protocol Number: VP-PR-IQ-001 Page 32 of 15

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