Equipment Qualification Protocols

1.0 Objective

To describe the Operational Qualification of Double Cone Blender and to define the specification of the system in order to:

• Ensure that the equipment meets the Operational/Design limits.

• Demonstrate that the equipment / system will perform reproducibly and consistently within its full range of operation according to manufacturer’s specification

• Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices

• Assure that the equipment / system performance is adequate to support the process for which the system is intended.

• Demonstrate that the suitability of the SOP is established for the equipment / system

2.0 Scope

The scope of this document applies to the operational qualification of Double Cone Blender installed in granulation area.

5.0 Operational Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

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1.0 PURPOSE

The purpose of performance qualification is to confirm through the provision of objective evidence, that the performance requirements for the Coating Machine with equipment ID.: XXXXXXXXXXX meet its intended use. 

2.0 SCOPE

The preparation of PQ applies to the Coating Machine installed in Coating area of YYYYYYY with equipment ID.: XXXXXXXXX.

3.0 PROCEDURE FOR PERFORMANCE QUALIFICATION

3.1 Flow output verification of the peristaltic Pump

3.1.1 Scope: The observed RPM value of the peristaltic pump shall be monitored for compliance with respective to its set values in the MMI.

3.1.2 Methodology/Sampling Plan

• Operate the Coating machine as per SOP.
• Collect solution in the solution holding tank and connect the inlet of the peristaltic pump on to the outlet valve of the tank.
• Set the RPM of the peristaltic pump at a particulate value in the MMI.
• Attach sample covers onto nozzle and collect the quantity of solution out in one minute.
• Seal the covers and weigh individually to get the flow rate (ml/min) from each nozzle at a particular set RPM of the peristaltic pump.
• Record the observation in table I given in this protocol.

3.1.3 Acceptance criteria:

• The observation RPM value of the peristaltic pump shall comply with its set value.
• The flow output shall be consistent from all nozzles. (For information purpose only)

3.2 Spray Pattern Checks.

3.2.1 Scope: The minimum atomization air pressure required to produce a cone-shaped spray pattern with suitable width at a particular RPM value of the peristaltic pump shall be recorded for information purpose only.                                                  

3.3 Methodology/Sampling plan:

• Operate the Coating Machine as per SOP
• Set the RPM of the Peristaltic pump at a particulate value and operate to start flow of solution from the nozzles.
• Apply atomization air pressure gradually till a cone shaped spray pattern with a suitable width at a particular RPM setting of the peristaltic pump.
• Record the atomization air pressure to achieve a cone shaped spray pattern with a suitable width at a particular RPM setting of the peristaltic pump.
• Record the observation in the table 2given in this protocol.

3.3.1 Acceptance criteria:

• A cone shaped spray shall be observed (For information purpose only)

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1.0 Overview

The Performance Re-Qualification of Fluid Bed Dryer is carrying out in order to provide the high degree of assurance that the equipment performed as intended and remain in the state of control.

2.0 Purpose

The purpose is to provide an outline for the Performance Re-qualification of equipment for performance attributes to verify that:

• Documented the verification of all aspects of the equipment that can affect product quality.

• To make an impact assessment of the critical components of the equipment’s on the material.

• To establish, check and document the performance of equipment in the established/predetermined operating ranges.

• The protocol shall define the test procedures, documentation, references and acceptance criteria to establish that the performance of the equipment shall meet the predetermined acceptance criteria.

• The equipment shall be used for the homogeneous drying of the wet mass with the help of hot air drying and fluidization process.

3.0 Background

The Fluid Bed Dryer supplied by Falcon Machineries, Equipment I.D. XXXX installed in Granulation at XYZ (Company Name) This protocol defines the methods and documentation that shall be used to evaluate the performance attributes of Fluid Bed Dryer. The Reason for this requalification is Periodic/Schedule Performance Requalification.

4.0 Performance Re-Qualification Procedure

The following procedure shall be used for performance of Fluid Bed Dryer:

• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Operate the machine as per respective standard operating procedure and set the required parameter in control panel as per product BMR.
• Record the observation in the protocol.
• The equipment shall be challenged with charging of Wet granulated material manufactured as per BMR. equipment.
• Drying of Material is done as per parameters mentioned in the Batch Manufacturing record.
• Sample for LOD shall be done from the 06 different location mentioned in protocol
• Record the Results of LOD in respective section given in the protocol.
• Sample quantity shall be collected approximately 2 g in at each location.
• All data shall be recorded in respective BMR and results shall be recorded in report observation table.
• Suitable conclusion shall be drawn after completion of Performance Re-Qualification.
• Any deviation observed during qualification shall be recorded in the observed deviation, corrective action and justification report section.
• Observed deviation shall be reported to the department head and quality head.
• If the observed deviation does not have any major impact on the qualification the final conclusion shall be provided.
• If the observed deviation has major impact on the qualification, deviation shall be reported to the manufacturer for the corrective action and qualification activity shall be done.

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1.0 Overview

The Performance Re-Qualification of Rapid Mixer Granulator is carrying out in order to provide the high degree of assurance that the equipment performed as per functional specification and remain in the state of control.

2.0 Purpose

The purpose is to provide an outline for the Performance Re-Qualification of equipment for performance attributes to verify that:

• Documented the verification of all aspects of the equipment that can affect product quality.

• To make an impact assessment of the critical components of the equipment’s on the material.

• To establish, check and document the performance of equipment in the established/predetermined operating ranges.

• The protocol shall define the test procedures, documentation, references and acceptance criteria to establish that the performance of the equipment shall meet the predetermined acceptance criteria.

• The equipment shall be used for the homogeneous mixing of the dry material and wet kneading by mixing and crushing the material with the help of high shear force accomplished by agitator.

3.0 Background

The Rapid Mixer Granulator supplied by Falcon Machineries, Equipment I.D. XXXXX installed in Granulation at XYZ (Company Name).  This protocol defines the methods and documentation that shall be used to evaluate the performance attributes of Rapid Mixer Granulator in accordance with the URS specifications and intended use. The Reason for this requalification is Periodic/Schedule Performance Requalification

4.0 Performance Re-Qualification Procedure:

The following procedure shall be used for Requalification of Rapid Mixer Granulator:

• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Operate the machine as per respective standard operating procedure and set the required parameter in control panel as per product BMR.
• Record the observation in the protocol.
• The equipment shall be challenged by using wet granulation product manufacturing process
• All the data shall be recorded in Batch manufacturing record.
• All the raw materials after sifting through the specified sieve are collected in the double lined polybags. The Rapid mixer granulator is charged with the material the quantity of which is mentioned in the bill of material.
• Dry mixing shall be carried out at slow RPM of impeller.
• After dry mixed, materials shall be used for granulation by using a freshly prepared binder. The binder shall be added to the dry mix blend at a uniform rate and the end point is decided by observing the coherent mass.
• The capacity of the rapid mixer granulator is 250 L as per the manufacturer’s specification.
• The performance of the equipment is challenged by charging with wet mass.
• All data shall be recorded in respective BMR and results shall be recorded in report observation table.
• The granulated mass shall be collected in the trolley and is taken for drying in the fluidized bed dryer.
• Suitable conclusion shall be drawn after completion of Performance Re-Qualification.
• Any deviation observed during qualification shall be recorded in the observed deviation, corrective action and justification report section.
• Observed deviation shall be reported to the department head and quality head.
• If the observed deviation does not have any major impact on the qualification the final conclusion shall be provided.
• If the observed deviation has major impact on the qualification, deviation shall be reported to the manufacturer for the corrective action and qualification activity shall be done

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1.0 Overview

The Performance Re-Qualification of Octagonal Blender is carrying out in order to provide the high degree of assurance that the equipment performed as intended and remain in the state of control.

2.0 Purpose

The purpose is to provide an outline for the Performance Re-Qualification of equipment for performance attributes to verify that:

• The system meets the user requirement Specification.

• Document the verification that equipment performs consistently and in the state of control.

• Assure that Octagonal Blender is adequate to support the process for which the system is intended.

3.0 Background

The Octagonal Blender supplied by Falcon Machineries; Equipment I.D. XXXX installed in Blending area at XYZ (Company Name). This protocol defines the methods and documentation that shall be used to evaluate the performance attributes of Octagonal Blender in accordance with the user requirement specifications and intended use. The Reason for this requalification is Periodic/Schedule Performance Requalification.

4.0 Performance Re-Qualification Procedure

The following procedure shall be used for Requalification of Octagonal Blender:

• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.

• Verification of performance of machine done by Blending of material.

• Operate the machine as per respective standard operating procedure and set the required parameter in control panel as per product BMR.

• Record the observation in the protocol.

• Sample for Blend uniformity shall be done from the 10 different locations mentioned in protocol

• One composite sample shall be taken from Blender

• Record the Results of Analysis in respective section given in the protocol.

• The Performance of Octagonal blender shall be evaluated for minimum and maximum load.

• Suitable conclusion shall be drawn after completion of Performance Re-Qualification.

• Any deviation observed during qualification shall be recorded in the observed deviation, corrective action and justification report section.

• Observed deviation shall be reported to the department head and quality head.

• If the observed deviation does not have any major impact on the qualification the final conclusion shall be provided.

• If the observed deviation has major impact on the qualification, deviation shall be reported to the manufacturer for the corrective action and qualification activity shall be done.

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1.0 Overview

The Performance Re-Qualification of Compression Machine is carrying out in order to provide the high degree of assurance that the equipment performed as intended and remain in the state of control..

2.0 Purpose

The purpose is to provide an outline for the Performance Re-Qualification of equipment to verify that:

• The system meets the user requirement Specification.
• Document the verification that equipment performs consistently and in the state of control.
• Assure that Compression Machine 27 Station is adequate to support the process for which the system is intended.

3.0 Background

The Compression Machine supplied by Fluidpack, Equipment I.D. XXXXX installed in Compression area at XYZ (Company Name). This protocol defines the methods and documentation that shall be used to evaluate the performance attributes of Compression Machine in accordance with the user requirement specifications and intended use. The Reason for this requalification is Periodic/Schedule Performance Requalification.

4.0 Performance Re-Qualification Procedure

The following procedure shall be used for Requalification of Compression Machine:

• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Verification of performance of machine done by monitoring the physical parameters of the product at the tablet compression stage.
• The performance verification of compression machine check at different speed, different thickness pressure and different level of powder in hopper.
• Operate the machine as per respective standard operating procedure and set the required parameter in control panel as per product BMR.
• Record the observation in the protocol.
• Any deviation observed during qualification shall be recorded in the observed deviation, corrective action and justification report section.
•  Observed deviation shall be reported to the department head and quality head.
• If the observed deviation does not have any major impact on the qualification the final conclusion shall be provided.
• If the observed deviation has major impact on the qualification, deviation shall be reported to the manufacturer for the corrective action and qualification activity shall be done.

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