Installation Qualification IQ of RMG

INSTALLATION QUALIFICATION IQ of RMG

TABLE OF CONTENT

1.0      PRE APPROVAL.

2.0      OBJECTIVE.

3.0      SCOPE.

4.0      EQUIPMENT / SYSTEM DESCRIPTION:

5.0      RESPONSIBILITIES.

6.0      PRE-REQUISITE.

7.0      METHODOLOGY.

8.0      DISCREPANCY AND CORRECTIVE ACTION REPORT.

9.0      ANNEXURE.

10.0    SUMMARY.

11.0    CONCLUSION.

12.0    ABBREVIATIONS.

13.0    REFERENCES.

14.0    POST APPROVAL.

1. PRE APPROVAL:

Signing of approval page of this document indicates the agreement with the Qualification approach described in this document. If any modification approach becomes necessary, a revision through change control shall be prepared, checked and approved. This document cannot be executed unless approved.

• OBJECTIVE:

The objective of this Installation Qualification Document is to provide guidelines for verification of static attributes of Rapid Mixer Granulator ID No:  , Installed at XXX  Limited.

• SCOPE:

The scope of this Document applies for the Installation qualification of Rapid Mixer Granulator ID No:  , by following the below mentioned test functions.

• Verification of Equipment Specification
• Identification and Verification of Supporting Utilities
• Verification of Equipment Installation
• Identification and Verification of Measuring Devices
• Identification of Programmable functional keys, Displays, Safety Features & Interlocks
• Identification and Verification of Documents
• Identification of Standard Operating Procedures
• Verification of Major Components & Accessories
• Verification of Specification of Major Components & Accessories
• Verification of Material of Construction.
• EQUIPMENT / SYSTEM DESCRIPTION:

RMG is mixing and granulating machine used for mixing and granulating powder with binder.

In RMG, main impeller maximizes micro mixing of ingredients by effecting optional diffusion correction. Irrespective of varying bulk densities, both during dry & wet mixing also chopper act for distribution of binder fluid and helps to from granules.

Rapid Mixer Granulator is designed to match all the requirements of cGMP. All components are easy to dismantle and to assemble for accessibility in cleaning. Unit is most ideal for dry and wet mixing and wet granulation mixing. Product bowl is provided with openable lid and required safety interlocks. The Motor speed is controlled through variable frequency drive.

• RESPONSIBILITIES:

The group comprising of representatives from each of the following departments shown in the table below and they shall be responsible for the overall compliance with this document.

• IDENTIFICATION OF EXECUTORS

Person involved in the execution of the document shall be trained on the concept of validation

• PRE-REQUISITE:

Training: Before processing for the qualification, the respective validation team shall be trained on the concept of validation. The training document shall be verified and shall be satisfactory

(Refer attachment for training record)

• METHODOLOGY:

Following test procedures are followed to qualify the equipment for its installation.

• VERIFICATION OF EQUIPMENT SPECIFICATION

Objective: To verify the equipment details against design data.

References & Tools required:

GA Layout

Measuring Tape

Procedure:

• check the system nameplate / identification plate is clearly visible.
• Verify the make, model no. & size of the equipment from the nameplate; record the serial no. and location of the equipment in the observation column of data sheet.
• Measure the dimensions using a measuring tape.
• For each component verified or recorded, indicate the method used in performing the verification in the “verification methodology” column as follows:
• Visual verification of actual installation – “Visually Verified”
• Verification through cross-referencing the manufacturer information
• Physical verification of actual installation – “Physically Verified”.

Acceptance criteria: The observed details for the given parameters should be same as per the manufacturer’s specifications. The measured dimensions should be within ±10% of specification.

Recording of Observations:

 Meet the acceptance Criteria [           ] Yes                            [           ] No

 Remarks:

 Reviewed by: ____________________                    Date: ______________________

• IDENTIFICATION AND VERIFICATION OF SUPPORTING UTILITIES

Objective: To identify and verify that all the utilities are installed to the equipment properly and are in compliance with the specifications.

References & Tools required:

• Functional / system specification
• Multimeter / Clamp Meter
• Electrical & Mechanical Schematics

Test procedure:

• Perform a visual inspection of the equipment support utilities listed on the below table.  Verify specified requirements for the equipment for each utility and record the actual information in the “actual” column on the data collection sheet(s). Verification should be made through visual inspection of the physical installation, nameplate information, and/or system instrumentation.
• Record, for informational purposes only, the actual information for the parameter(s) that has not been specified.
• For each parameter(s) that cannot be visually verified, the specified parameter must be verified through independent sources of information provided by the vendor/ manufacturer (i.e. specification sheet, name plate, signed/dated letter from manufacturer/vendor or approved drawing).  All sources of information must be documented on the table or an itemized cross reference list and attached to the protocol in the appropriate annexure. 
• All instrumentation used in this verification must be calibrated prior to testing and a copy of the metrology calibration certificate shall be available at facility and/or attached to the document in the appropriate annexure.
• Record all observations in the below table. Record the details of instruments used for testing purpose.
• For each component verified or recorded, indicate the method used in performing the verification in the “Verification Methodology” column as follows:
• Visual verification of actual installation – “Visually Verified”
• Verification through cross-referencing the manufacturer information
• Physical verification of actual installation – “Physically Verified”.

Acceptance Criteria:

• Each utility of the equipment, listed on the data sheets, shall be installed in accordance with the equipment specification. All parameters shall be in compliance with the equipment specifications. No leakages should be observed.
• All the utilities and drains should be connected without any leakage. Slope should be maintained wherever required.

Recording of Observations:

1. Electrical: 

• Non Electrical:

Reference Instruments Details:

   Meet the acceptance Criteria           [           ] Yes                            [           ] No

   Remarks:

    Reviewed by: ____________________                            Date: ______________________

• VERIFICATION OF EQUIPMENT INSTALLATION

Objective:

To verify that the equipment (including sub-components & accessories) is properly installed as per the manufacturers specifications / equipment requirements.

References & Tools required:

  Spirit level indicator

Test procedures:

• Levelling and installation: Using a spirit level indicator check the levelling of the equipment in both the directions. Check and verify that the equipment has been installed as per the drawings.
• Cleanliness: Visually check that the equipment is cleared of any debris and cleaned.
• Electrical connections: Check and verify physically that the electrical connections are connected properly; also check for the earthing of the same by comparing with the wiring diagrams / appropriate references. Also verify that all the wires / connections are properly identified and numbered and that there are no loose unidentified wires present.
• Labelling: Check and verify physically that all components labelled and direction of flow (wherever applicable) properly.
• Physical damage: Check and verify physically that no physical damage has occurred to equipment, components, measuring devices (if any) and record the observations.

Acceptance criteria:

• Levelling and Installation: Equipment is securely anchored and levelled properly. The equipment should be installed as per the specifications and respective drawings.
• Cleanliness: All access ports are examined and cleared of any debris.
• Electrical Connections: The electrical wiring should be as per the electrical diagrams and all the terminals / wires / connections should be identified and appropriately numbered and there should not be any loose unidentified wires present in the equipment. Wiring diagram should be taped to inside the panel.
• Labelling: All the components (which required) shall be labelled and direction of flow is mentioned wherever is applicable.
• Physical damage: No physical damage shall be observed for all components of the system.

 Recording of Observations:

Meet the acceptance Criteria  [           ] Yes                            [           ] No

Remarks:

Reviewed by: ____________________                                 Date: ______________________

• IDENTIFICATION AND VERIFICATION OF MEASURING DEVICES

Objective: To identify and verify the measuring device present in the equipment.

References & Tools required: Not applicable.

Test procedure:

• Identify the measuring devices fixed on the equipment. Check that the measuring devices nameplate / identification plate is clearly visible. Verify and record details of the make, type, range, Serial no. and location of the measuring devices
• After identification and verification, the device shall be numbered as per the respective SOP.
• Verify the calibration certificates for each identified measuring device (if available)

Acceptance criteria:

• Each measuring device should be complying with the specifications.
• No physical damage shall be observed for all components of the system.

Note: If any measuring device is not calibrated / not in the validity shall arrange for Calibration by using internal or external facility.

    Recording of Observations:

   Remarks:

   Reviewed by: ____________________                                                                Date: ______________________

• IDENTIFICATION OF PROGRAMMABLE FUNCTION KEYS, DISPLAYS, SAFETY FEATURES & INTERLOCKS 

Objective: To identify the programmable function keys, displays,safety features & interlocks present with the equipment/system.

References & Tools required: Not applicable.

Test procedure: Visually identify all the programmable function keys, displays,safety features and interlocks present with the equipment as per the specifications / manufacturer instructions and visually verify the same to ensure that they are connected properly and free from any physical damage.

Acceptance criteria: Each programmable function keys, displays,safety features & interlocks available should be connected as per the specifications.

Recording of Observations:

Meet the acceptance Criteria  [           ] Yes                            [           ] No

Remarks:

Reviewed by: ____________________                     Date: ______________________

• IDENTIFICATION AND VERIFICATION OF DOCUMENTS

Objective: To identify and verify all the documents associated with the equipment are available.

                    References & Tools required: Not applicable.

Test procedure: 

• Verify the availability of various general documents as mentioned in the Table.
• Record the documents details and locations at which documents are available in respective columns
• Relevant documents shall be maintained at the facility and a copy may be attached to the protocol as an annexure.

Acceptance criteria:

All the documents shall be available at the time of execution of this protocol.

 Recording of Observations:

  Remarks:

 Reviewed by: ____________________                    Date: ______________________

• IDENTIFICATION OF STANDARD OPERATING PROCEDURES

Objective: To identify the SOP’s for the equipment.

References & Tools required:

Not applicable.

Test procedure: Identify all the relevant SOP’s for operation, cleaning, preventive maintenance and calibration of the system. Draft copy of the SOP’s identified should be prepared based on the instructions / guidelines provided in the operating and maintenance manual.

Acceptance criteria: All SOP’s should be identified for all the identified processes.

Recording of Observations:

 Remarks:

Reviewed by:  Date:

• DISCREPANCY AND CORRECTIVE ACTION REPORT:

Document the discrepancies observed during the Installation qualification of the equipment in the below mentioned table.  When all the discrepancies are satisfactorily resolved or an approved action plan is developed which ensures that the discrepancy will be resolved, document that the system is ready for next step in the qualification.

• Deviation

• Impact on operation

• Justification for acceptance

      Prepared by                              Reviewed by                                         Approved by

      Sign/ date:                                Sign/ date:                                             Sign/ date:                              

• ANNEXURE:

• SUMMARY:

• CONCLUSION:

• ABBREVIATIONS:

1. REFERENCES:
2.  Design qualification of Rapid Mixer Granulator
3. Validation Master Plan

POST APPROVAL:

 Signing of Report page of this document indicates the acceptance of Installation Qualification   approach described in this document.

INSTALLATION QUALIFICATION REPORT FOR RAPID MIXER GRANULATOR RMG-01 (REV-00) 800 L

Installation Qualification IQ of RMG and its technical specification:

   Prepared by:

   Reviewed by:

   Approved by:

DATASHEET – A

      Date: ___________

Specification of the equipment for all components required against the Purchase Order specifications

Verified by:

    Name                                 Signature                           Date      

DATA SHEET B

Date: ____________

Check whether the Process and Utility pipelines are connected as per P&ID

Verified by:

Name                                     Signature                              Date

DATA SHEET C

Date: ____________

Check for electrical / instruments components and its accessories

Electrical:

Instruments:

Verified by:

Name                                 Signature                             Date

DATA SHEET- D

Date: ____________

Check for safety devices specifications against its design parameters

Verified by:

Name                                     Signature                             Date

DATA SHEET- E

Date: ___________

Equipment spacing and leveling

Verified by:

        Name                                   Signature                                             Date

CONCLUSION:

Rapid mixer granulator system bearing Tag No RMG-01 is qualifying / is not qualifying the Installation qualification test as per the acceptance criteria described in this Protocol No 000111 Rapid mixer granulator system RMG-01 can be / cannot be tested for its Operational Qualification as per Protocol No-0000.

Verified by:

Name                                     Signature                         Date

RMG & its working principle