MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT------------------------------------------------------------------------------------------------------------------

VIBRO SIFTERVIBRO SIFTER

30” DIA. (GMP MODEL)

OPERATING OPERATING QUALIFICATION

CLIENT M/s. Milan Laboratories India Pvt. Ltd,

PARTY’S REF. (P.O) NO.

MONTH & YEAR OF MFG. 2009-2010

LOCATION Panvel

OUR REF. NO.

JOB NO.521006

MODEL NO.30VS

Allied MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT Unit No. 17, Param Industrial Estate, Naik Pada,

Waliv, Vasai (East), District Thane- 401 208, Maharashtra, India. Fax: 0250 –: 2451675

Tel : 6451697, 6454301, 2451674Email: admin@alliedworld.in

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

PROTOCOL APPROVAL COVER PAGE

The signatures below indicate approval of this protocol.Once signatures are obtained, execution of the protocol may begin.

Department Authorized Person

Signature Date

Initiated by

Reviewed by

Approved by

CONTENTS

Sr. No. TITLE1.0 Introduction2.0 Rationale 3.0 Responsibilities4.0 Equipment Critical to Study5.05.15.25.35.4

Qualification Description Prerequisites Start Up Emergency Stop Power Failure

6.0 Criteria For Acceptability7.0 Conclusion

OQ Data SheetsOperational Qualification Approval Page

1.0 INTRODUCTION

1.1 The objective of this Protocol is to provide guidelines for the installation of the Vibro Sifter.

1.2 Installation details for the Vibro sifter are available in installation qualification Protocol (II/PP/RPT/QUA/18). The operation of the equipment is described in the SOP titled operation of Vibro sifter SOP No. II/PP/SOP/OPR/3

1.3 The objective of this study is to assess the ability of the sifting equipment to operate correctly as per the designed parameters. The study will also assess the electrical operations.

2.0 RATIONALE FOR QUALIFICATION PROGRAMMEPage 2

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

The sifter functions by imparting vibratory energy to the granules in the bowl by means vibrating motor. The amount of energy imparted is proportional to the motor speeds. These functions of the equipment will be challenged within the anticipated operational limits. Also, all electrical and sealing operations of the equipment shall be qualified. The equipment will be validated for the following functions in manual and auto mode:

2.1 Critical operating parameters: 2.1.1 Leakage 2.1.2 Material movement 2.1.3 Vibration.

2.2 Power Failure

3.0 RESPONSIBILITIES

3.1 The responsibility of the Validation Team is overall adherence to this protocol.Specific duties include:

3.1.1 Monitoring Protocol completeness, accuracy, technical excellence and applicability.

3.1.2 Scheduling and Operational Qualification activity3.1.3 Maintenance and calibration of validation equipment3.1.4 Conducting the Operational Qualification activity3.1.5 Data review of validation Protocol preparation3.1.6 Approval of Protocol

3.2 The responsibility of the Q.A. Department includes:

3.2.1 Issue validation data sheet to the validation team 3.2.2 Review of validation data3.2.3 Approval of validation Protocol

3.3 The responsibilities of Formulation Development are as follows:

3.3.1 To make critical equipment available for validation. (The equipment is listed in Section 4 of this protocol)

3.3.2 Review of data and approval of Protocol

3.4 Exceptional Conditions and Deviations

Any minor changes or deviations that are necessary to comply with this protocol will be documented in the final Protocol. Any significant changes or deviations altering the scope or intent of this protocol require prior approval by the original signatories and documentation in the final Protocol.

4.0 EQUIPMENT CRITICAL TO STUDY4.1 Calibrated Stopwatch (tag no IIE 29) 4.2 Calibrated Technometer (tag no. IIE 30) 4.3 Vibro Sifter (Tag no IIE - 55)

5.0 QUALIFICATION PROGRAMME

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5.1 Prerequisites

5.1.1 Confirm that the equipment/system is installed, the Installation Qualification completed and installation package approved, and is ready for operation.

5.1.2 Confirm that the operating SOP exists, in draft or approved form, to support operational testing.

5.1.3 Verify that all instruments associated with this equipment/system, including those to be used for testing, have been calibrated and that the re-calibration dates will not expire before execution of this protocol has been completed.

5.1.4 Verify that all materials and test equipment are available for the execution of this Protocol.

5.2 Start-Up5.2.1 Ensure that the main electrical supplies are ‘ON’5.2.2 Switch ‘ON’ the power at the main switch cabinet.5.2.3 Ensure that equipment is cleaned before operation.5.2.4 Checks that sieving screen fits properly.5.2.5 Ensure that all gaskets are closed.5.2.6 Ensure that material moves in circulation motion5.2.7 Start the sifting operation5.2.8 Run the machines for 30 mins.

ACCEPTANCE CRITERIA: All operations should be smooth.

5.3 Noise Generation5.3.1 Run the Vibro Sifter for some time and observe for generation of noise.

ACCEPTANCE CRITERIA: No noise generation.

5.4 Direction of Rotation5.4.1 check the direction of motor

5.5 Seals5.5.1 Visually check for leaks from top lid and top deck.5.5.2 Visually check for leaks from ‘C’ Clamp.

ACCEPTANCE CRITERIA: No leakage

6.0 CRITERIA FOR ACCEPTABILITYThe Operations Qualification of Vibro Sifter shall be considered acceptable if individual operating parameters fall within anticipated acceptable limits. If the results do not meet anticipated acceptance limits, the review team shall meet and agree corrective actions.

7.0 CONCLUSIONThe collected data shall be analyzed, evaluated and reviewed against the acceptable limits for operation. The conclusions shall be drawn based on review of data and suggestions shall be made to optimize the operational efficiency of equipment.

DRAWING - I

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OQ DATA SHEETS

IDENTIFICATION OF PERSONNEL PERFORMING OPERATIONAL QUALIFICATION

DEPARTMENT SIGNATURE DATE

OQ DATA SHEET

STEP REQUIREDRECORDED ACCEPTANCE

CRITERIA

5.1.1

Confirm equipment / system installed, I.Q. complete and ready for operation.

IQ documents reviewed and approved.

5.1.2 Confirm SOP exists SOP exists

5.1.3Confirm instruments calibrated and re-calibration date not expired.

All instruments calibrated.

5.1.4Verify all materials and test equipment available Test equipments available

5.1.5Verify electrical supplies are “ON”

All utilities available in right capacity.

5.1.6 Verify equipment cleaning Should be cleaned

5.1.7 Sieving screen Fits properly

5.1.8Should not generate noise from damp and feed hopper

No noise

5.1.9 Material should move in circulation direction

Material movement in circulation direction

5.1.10

Continuous material movement through discharge chute

Material moves out of discharge chute continuously

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OPERATIONAL QUALIFICATION APPROVAL PAGE

OBSERVATION:

CONCLUSION:

SUGGESTION:

_________________ _________________ _________________ PREPARED BY: REVIEWED BY: APPROVED BY:(Formulation Technologist) (Manager Formulation Development) (Quality Assurance Dept)

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