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VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE GMP MODEL Purchase Order No.: HPP/170291 DATED 11-03-04

Cip Machineries Pvt. Ltd. Registered Office : 10,11 Umiya Estate, Nr.Bharat Party Plot, N.H.No.8, Amraiwadi, Ahmedabad 380 026. Gujarat, INDIA. Phone: 91-79-2287 54 10 91-79-2289 25 30 91-79-2297 04 06-7-8 TeleFax: 91-79-2289 14 10

Works : Plot No.1903, Phase IV, Opp. Maradia Steel Unit-3, G.I.D.C., Vatva, Ahmedabad 380 026. Gujarat, INDIA. Phone: 91-79-2583 59 08 91-79-2583 53 41-2-3 TeleFax: 91-79-2583 58 53

E-Mail : [email protected]

[email protected] Visit us on Internet at :

www.cipmach.com / www.roll-compactor.com

OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

Table of Content Section No. 1.0 2.0 3.0 4.0 5.0 6.0 7.0

Description

7.1 7.2 7.3 7.4 7.5 7.6 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0

Title Objective Scope Re – qualification criteria Over view of equipments / description Definition Responsibilities Quality Engineering Quality Assurance Quality Control Purchase Production Engineering Indented use of instrument Acceptance Criteria Reference Installation Qualification Standard Operating Procedure Operation Qualification Performance Qualification Preventive Maintenance Schedule Final Conduction and recommendations

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Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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1.0 Title : Protocol for qualification of Dust Extractor Machine. 2.0 Objective : The objective of this protocol is to define the installation, operation and performance Qualification requirement and qualifying criteria recommended from its Design specification.

3.0 Scope : This qualification protocol is applicable to the Dust Extractor Machine. 4.0 Re – qualification Criteria Re – qualification will be recommended in the following cases: a. When there is change in location of the equipment. b. When there is major modification in the equipment. c. When there is major breakdown, which have direct impact on performance of the equipment. Re – qualification shall be recommended by Quality Engineering.

5.0 Overview of Equipment / Description: The equipment is a self-contained unit for collection of dust from the tableting etc. machine.

6.0 Definition Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists of the following: a. Installation Qualification: A documents verification of the installation in the selected user environment to comply with the approved design, the manufacturer’s recommendations and or user requirements. b. Operation Qualification: A documents demonstration that facilities and operation work to functional design specifications. c. Performance Qualification: A documents verification of the performance in the selected user environment to comply with the approved design, the manufacturer’s recommendations and or user requirements.

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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7.0 Responsibilities: 7.1 Quality Engineering: - Preparation, approval and implementation of the protocol. - On going compliance of the system. - Organizing the activities related to qualification. - Co – ordination with production, engineering purchase department. - Qualification reports preparation. 7.2 Quality Assurance: - Review, monitoring and approval of the protocol. - On going compliance of the quality system. 7.3 Quality Control: - Analysis of samples if any. - Recording the QC raw data. 7.4 Purchase: - Organization Preparation, approval and implementation of the protocol. - Purchase order preparation. - Co-ordination with vendor for related activities. 7.5 Production: - Organizing the activities related to qualification in production area. - SOP preparation for operation. - Routine calibration and maintenance implementation. - Report review and training of users. 7.6 Engineering: - Providing the design specification. - Inspection at vendor site. - Utilities arrangement for equipment. - Organize the calibration of parts of equipments & instruments as a whole. - Organizing the activities related to qualification.

8.0 Intended use of the Equipment: The Dust Extractor Machine shall be used for suction of dust. 9.0 Acceptance Criteria: a. Equipment shall be supplied and installed as per pre – determined specification Purchase Order. b. Material of construction and finish surface of equipment shall be as per pre – determined specification. c. All Utilities connected with the equipment shall be as per requirement. d. All components of the equipment shall work or function as defined. e. Equipment shall perform for its intended use as specified.

10.0

Reference:

a. Technical specification / Operation Manual b. GA drawing / Exploded drawing c. Purchase order copy

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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d. FAT and SAT report recommendation.

11.0

Installation Qualification:

11.1 Equipment Details: Equipment Name Dust Extractor Machine

Equipment Type

Designed By

Location (Floor) Location (Plant) Date of Installation

11.2 Major Components & Material of Construction: Sr. Description Specification No. 01 Chamber SS 316 02 Impeller CIP MAKE 03 Cotton Bag CIP MAKE 04 Motor 1 Hp 05 Wheel Pu 11.3 Utility Details: Sr. Utilities recommended by No. the vendor

Specification

01 02 03 04 05 06

1 Hp, 3 phase NA NA NA NA NA

Electrical Chilled water Cooling water Hot water Compressed air Steam pressure

11.4 Installation Checks: Sr. Test No. 01 Position as per GA drawing 02

Electrical connection

04

Direction of Motor

05

Earthing

Actual

Remarks

Utility connected with the equipment

Remarks

Test Procedure Ensure that position of equipment is as per the GA drawing Check 3 phase supply to starter through a proper isolator with suitable backup MCBs. Check direction of motor depending upon suction Check the earthing of machine

Observation

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE Installation done by: 11.5

PAGE 6 of 13 Verified by:

FINAL REPORT

Summary: The equipment shall be procured as per specification. Installation is carried out as per manufacturers recommendations and user applicability. Supporting utilities will be connected. Analysis / Evaluation: The machine shall be installed at the location. Supporting utilities shall be connected and Used for Functioning properly. Standard operating procedure shall be identified and listed. History card shall be prepared for the equipment. The user shall verify all relevant critical document and drawing.

Reviewed & Inspected by: ___________________

Date :

Approval: Area Representative

Production Engineering Services Quality Engineering Quality Assurance

Signature

Date

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

12.0

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Standard Operating Procedure:

Draft SOP of the equipment shall be available SOP No.

Title

Location

Effective Date

Revision No.

Remarks

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

13.0

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Operational Qualification:

13.1 Procedure: The equipment (Dust Extractor Machine) shall be checked for the following parameters: 13.2 Operational Checks: Sr. No. 01

Activity

Specification

On / Off Test

03 04

Start Machine with proper suction direction Test for vibration

Machine should be ON and OFF with operating buttons Smooth running

05

Test for noise

06

Stopping of the Machine

Observation

Remarks

No abnormal vibration No abnormal Noise should be there. Machine should STOP

13.3 Safety Features: Sr. No. 01 02

Safety features provided with the equipment Proper earthing to the machine Safety interlocks if any

Method of Verification

Target

Ensure that there is no loose earthing Should work as designed

Complete earthing No deviation

Actual

Remarks

13.4 Training: Following operating / maintenance personnel were trained by the vendor and authorized to operate or carryout routine maintenance of the equipment. Name

Designation

Date of Training

Trained by

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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13.5 FINAL REPORT Summary The operation of the equipment DUST EXTRACTOR MACHINE is carried out as per standard operating procedure. The equipment performs within the assigned limits when operated as per approved standard operating procedure. Operating parameters that have a significant impact on the equipment ability to operate and achieve the process are satisfactory and confirms to the acceptance criteria. Equipment: DUST EXTRACTOR MACHINE Location Purpose

: : Use for suction of the dust.

Frequency of Validation: Validation due on component of the machine.

or the event of any change in critical

"THE EQUIPMENT "DUST EXTRACTOR MACHINE” VALIDATED AND RELEASED FOR USE.

Approval: Area Representative

Production Engineering Services Quality Engineering Quality Assurance

Signature

Date

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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14.0 PERFORMANCE QUALIFICATION 14.1

EQUIPMENT VALIDATION

The simulation of the process was carried out by connection with the specific machine. Simulation of the process consist of the following: Sr.No. Activity 01

Proper assembly of cotton bags

02

Position of chamber

03

Powder suction

Functional Acceptance Criteria As per the details given with the operating manual It should be properly fixed with machine and fixed with knobs. It should be from the specific machine with this machine to be attached.

Status / Observation

14.2 PERFORMANCE QUALIFICAION EVALUATION: NAME OF TABLET: PERFORMANCE CRITERIA - BEFORE CONNECTING THIS MACHINE: 1. APPERANCE : 2. ANAYALSIS PERFORMANCE CRITERIA - AFTER CONNECTING THIS MACHINE: 1

2

3

APPERANCE ANAYALSIS 14.3

DATA EVALUATION AND CONCLUSION:

Based on the quality control results generated by simulating the process and its review, it said that machine performs satisfactory and confirming to the acceptance criteria.

Inspected by: _____________________Date :

can be

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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14.4 FINAL REPORT Summary The performance of the equipment DUST EXTRACTOR MACHINE was carried out as standard operating procedure.

per

The equipment performs within the assigned limits when operated as per approved standard operating procedure. Performance parameters that have a significant impact on the equipment ability to operate and achieve the process are satisfactory and confirms to the acceptance criteria. Equipment: DUST EXTRACTOR MACHINE Location Purpose

: : Use for suction of the dust.

"THE EQUIPMENT "DUST EXTRACTOR MACHINE VALIDATED AND RELEASED FOR USE.

Approval: Area Representative

Production Engineering Services Quality Engineering Quality Assurance

Signature

Date

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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15.0 On – going Activities 15.1 Preventive Maintenance Schedule: Sr. No.

Preventive maintenance details

Any major change

Performed by

Remarks

15.2 Change in the History card: New equipment installed on: Date Sr. Change No recommended by

Reason for change

Modification Details

15.3 Modification with recommendation for re – qualification:

Re-qualification Remark

Confidential VALIDATION PROTOCOL FOR DUST EXTRACTOR MACHINE

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16.0 Final Conclusion and Recommendation:

Approval: Area Representative

Production Engineering Services Quality Engineering Quality Assurance

Signature

Date