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

VIBRO SIFTER
30 DIA. (GMP MODEL) OPERATING QUALIFICATION
CLIENT PARTYS REF. (P.O) NO. MONTH & YEAR OF MFG. LOCATION OUR REF. NO. JOB NO. MODEL NO. 521006 30VS 2009-2010 Panvel M/s. Milan Laboratories India Pvt. Ltd,

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, 2451674 Email: 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 Initiated by Reviewed by Approved by Authorized Person Signature Date

CONTENTS
Sr. No. 1.0 2.0 3.0 4.0 5.0 5.1 5.2 5.3 5.4 6.0 7.0 TITLE Introduction Rationale Responsibilities Equipment Critical to Study Qualification Description Prerequisites Start Up Emergency Stop Power Failure Criteria For Acceptability Conclusion OQ Data Sheets Operational Qualification Approval Page

1.0

INTRODUCTION 1.1 1.2 The objective of this Protocol is to provide guidelines for the installation of the Vibro Sifter. 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 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.
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1.3

2.0

RATIONALE FOR QUALIFICATION PROGRAMME

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 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.2 Monitoring Protocol completeness, accuracy, technical excellence and applicability. Scheduling and Operational Qualification activity Maintenance and calibration of validation equipment Conducting the Operational Qualification activity Data review of validation Protocol preparation Approval of Protocol

The responsibility of the Q.A. Department includes: 3.2.1 3.2.2 3.2.3 Issue validation data sheet to the validation team Review of validation data Approval of validation Protocol

3.3

The responsibilities of Formulation Development are as follows: 3.3.1 To make critical equipment available for validation. equipment is listed in Section 4 of this protocol) 3.3.2 Review of data and approval of Protocol (The

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 STUDY 4.1 Calibrated Stopwatch (tag no IIE 29) 4.2 Calibrated Technometer (tag no. IIE 30) 4.3 Vibro Sifter (Tag no IIE - 55) QUALIFICATION PROGRAMME
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5.0

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5.1

Prerequisites 5.1.1 5.1.2 5.1.3 5.1.4 Confirm that the equipment/system is installed, the Installation Qualification completed and installation package approved, and is ready for operation. Confirm that the operating SOP exists, in draft or approved form, to support operational testing. 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. Verify that all materials and test equipment are available for the execution of this Protocol.

5.2

Start-Up 5.2.1 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 motion 5.2.7 Start the sifting operation 5.2.8 Run the machines for 30 mins. ACCEPTANCE CRITERIA: All operations should be smooth.

5.3

Noise Generation 5.3.1 Run the Vibro Sifter for some time and observe for generation of noise. ACCEPTANCE CRITERIA: No noise generation.

5.4 5.5

Direction of Rotation 5.4.1 check the direction of motor

Seals 5.5.1 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 ACCEPTABILITY The 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. CONCLUSION The 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.

7.0

DRAWING - I
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OQ DATA SHEETS
IDENTIFICATION OF PERSONNEL PERFORMING OPERATIONAL QUALIFICATION
DEPARTMENT SIGNATURE DATE

OQ DATA SHEET
RECORDED ACCEPTANCE CRITERIA

STEP

REQUIRED

5.1.1

Confirm equipment / system installed, I.Q. complete and ready for operation. Confirm SOP exists Confirm instruments calibrated and recalibration date not expired. Verify all materials and test equipment available Verify electrical supplies are ON Verify equipment cleaning Sieving screen Should not generate noise from damp and feed hopper Material should move in circulation direction Continuous material movement through discharge chute

IQ documents reviewed and approved. SOP exists

5.1.2

5.1.3

All instruments calibrated. Test equipments available All utilities available in right capacity. Should be cleaned Fits properly No noise Material movement in circulation direction Material moves out of discharge chute continuously

5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9

5.1.10

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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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