Friability Tester IQ Protocol

Installation Qualification Protocol For The Pharma Test Auto-Friability Tester (PTF E/ER) Serving The Solid Dosage Manufacturing and Production Laboratory Red River College, Winnipeg, Manitoba, Canada

Document Number: IQ-1001 Date Issued: 2015.02.06 Revision: 3

Prepared By: James Yuchen Huang

Doc. #: IQ-1001 Rev. #: 3 Effective Date: 2015.03.05

2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 2 of 25 Initial Approval 1. Author's Signature:

By signing, the Author, has indicated and acknowledged that this protocol has been prepared in accordance with existing standards and accurately reflects the actions necessary for validation of the Pharma Test Auto-Friability Tester. Typed/Printed Typed/Print ed Name, Title James Y. Huang, Validation Lead

Signature

Date

2. Reviewers’ Reviewers ’ Signature: By signing, the Reviewer(s), have indicated and acknowledged that this protocol accurately reflects the actions necessary for validation of the Pharma Test Auto-Friability Tester. Typed/Printed Typed/Print ed Name, Title

Signature

Date

3. Approvers’ Approvers’ Signature: By signing, the Approver(s), have indicated and acknowledged that this protocol, documentation and information complies with the Validation Master Plan (Doc #: VPM-100), regulatory requirements, and cGMP and GMP guidelines. Typed/Printed Typed/Print ed Name, Title

Quality Assurance Manager

Production Manager

Validation/ Engineering Manager

Signature

Date


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 3 of 25 Revision History Revision 0

Revision Date 2015.02.06

Reason for Revision/Change Request [Reference to Change Control Document] Initial Issue [Doc. #: N/A]

1

2015.02.12

Specific details with the Pharma Test Auto-Friability Tester – PTF E/ER from user manual [Doc. #: N/A]

2

2015.02.27

Revised from N. Schepp comments and recommendations

Revised By James Y. Huang James Y. Huang James Y. Huang


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 4 of 25 Table of Contents

Initial Approval ................................................................................................................ 2 Revision History .............................................................................................................. 3 Table of Contents............................................................................................................ 4 Signatures: ...................................................................................................................... 5 1. Introduction ................................................................................................................. 6 1.1 Objective................................................................................................................ 6 1.2 Compliance ............................................................................................................ 6 1.3 Scope .................................................................................................................... 6 2. Responsibilities .......................................................................................................... 7 3. Equipment and Systems Management..................................................................... 8 3.1 Description........................................................................................................ 8 3.1.1 Equipment Location .............................................................................................. 8 3.1.2 Equipment Manufacturer....................................................................................... 8 3.1.3 Equipment Function .............................................................................................. 8 3.1.4 Clearance, Utility, and Environmental Requirements ............................................ 8 3.2 Documentation.................................................................................................. 9 3.2.1 SOPs ......................................................................................................................... 9 3.2.2 Equipment.................................................................................................................10 3.3 Measuring Devices ......................................................................................... 11 3.4 Training................................................................................................................ 12 4. Instructions for Execution ....................................................................................... 13 4.1 General Instructions .....................................................................................................13 4.2 Special Pre-cautions ....................................................................................................13 5. Actual Execution .................................................................................................... 14 6. Visual Inspection and Verification .......................................................................... 15 6.1 Packaging and Shipping ................................................................................. 15 6.2 Parts and Components ................................................................................... 16 6.3 Utilities and Environment ................................................................................ 17 7. Hook Up and Instrumentation................................................................................. 18 8. Deviations and Non-Standard Occurrences ........................................................... 21 Deviation ID: ................................................................................................................. 21 Description of Deviation ................................................................................................ 21 Investigation findings..................................................................................................... 21 CAPA completed:.......................................................................................................... 21 Initial/Date..................................................................................................................... 21 9. Conclusion ............................................................................................................. 22 Execution Approval ....................................................................................................... 23 Appendix A ................................................................................................................... 24 Appendix B ................................................................................................................... 25


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 5 of 25 Signatures:

The identity of all individuals involved in approving, executing, or reviewing the protocol must be completed and verified on this signature page. Name James Y. Huang

Role Validation Lead

Company Red River College

Signature

Initials

Reviewer Reviewer Reviewer Quality Assurance Manager Production Manager Validation/Engineering Manager

Comments:

The information above has been reviewed and verified as correct. Reviewed By: ______________________________________

Date: ______________


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 6 of 25 1. Introduction 1.1 Objective

The purpose of this Installation Qualification protocol is to outline the requirements and planned actions relating to all components, systems, and functionality associated with the installation of the Pharma Test Auto-Friability Tester. 1.2 Compliance This protocol is written to comply with the validation policy requirements, as stated in the Validation Master Plan (Doc #: VPM-100), and the applicable sections of the cGMP and GMP guidelines. The validation of the Pharma Test Auto-Friability Tester system is a cGMP and GMP requirement and will follow the processes outlined in the guidelines. 1.3 Scope This protocol will examine the Pharma Test Auto-Friability Tester and applicable utilities. This installation qualification protocol will verify the mechanical unit and components, facility, utilities, and any other components that are necessary for the system to operate. The software systems and utility connections will be verified in this protocol, but testing and documentation will be completed according to their respective protocols and forums. Related validations, such as process and cleaning, that should be established prior to the completion of this installation qualification protocol and will support of the Pharma Test AutoFriability Tester will not be verified in this protocol. These related validations will be defined and documented within their respective validation protocols. They can be cross-referenced to this protocol to meet requirements and ensure compliance.


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 7 of 25 2. Responsibilities

The activities associated with this protocol are the responsibility of the following individuals and groups: Individuals / Groups Management

General Responsibilities    

Quality Assurance







Validation

 

Engineering

  

Production



Responsible for project management and oversight Ensuring overall objectives are met Interacting with QA to ensure compliance Reviewing and approving validation documentation Assuring compliance with appropriate regulatory requirements and guidelines Conducting investigations and corrective actions on deviations prior to/during/conclusion of validation Approving validation phases, qualifications, and statuses Responsible for writing and supervising the preparation of protocols Reviewing and approving protocols for execution Ensuring all equipment is properly installed and operational for execution Providing technical support to validation team(s) Reviewing and approving protocols for execution Providing necessary materials needed for validation; such as, but not limited to : trained operators, supplies, process materials


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 8 of 25 3.

Equipment and Systems Management

3.1

Description

3.1.1

Equipment Location

The Pharma Test Auto-Friability Tester is located on the premises of Building A, Room 200 of Red River College at 2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada. 3.1.2

Equipment Manufacturer

The unit is manufactured by PHARMA TEST Apparatebau GmBH, Siemensstrasse 5, D-63512 Hainburg (Germany). 3.1.3

Equipment Function

The Pharma Test Auto-Friability Tester comprises of defined Plexiglas-Abrasion and/or Plexiglas-Roche drums that are attachable to the main unit. The Pharma Test Auto-Friability Tester can operate at fixed and/or variable drum speeds using the 6 internally programmed buttons. The 10mm 4-digit LED display shows information related to parameter settings as well as indicates the elapsed time or number of revolutions. Applicable functions, as defined in the PTF E/ER Design Qualification document (DQ1001), will be verified to the user specification requirements. All equipment and components involved in the applicable functions will also be verified to the PTF E/ER Purchase Order (QA4081) prior to installation. The Pharma Test Auto-Friability Tester will function to carry out the <1216> tablet friability test, as defined in USP 29, or in absence of, the most recent USP volume. 3.1.4

Clearance, Utility, and Environmental Requirements

The Pharma Test Auto-Friability Tester has to have a minimum of 10cm rear and side clearance with a total 60cm bench space. The bench space is to be clean, dry and level can support a minimum weight of 30 kg. The Pharma Test Auto-Friability Tester has a power consumption of 0.5A, requiring an electric power at 110V-230V or a frequency range 50-60 Hz. The operating temperature has a limit of +20oC to +40 oC with humidity no less than 80% rF.


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 9 of 25 3.2

Documentation

3.2.1 SOPs In the sections below, record the identification of each SOP used in execution and tests of the installation, operation, and performance qualifications. Each SOP must be identified with their document number, version, location, and format. All documentation practices will also ensure compliance with the General Documentation SOP (QA-1008). Each item listed is to be verified by including the initials and date of the reviewer responsible. Document Title SOP for Solid Dosage Manufacturing and Production Laboratory Equipment Documentation General Documentation SOP

Doc. # QA-1011

Version 4

Location 1. QA Filling 2. QMS > Equipment > SD-005 > SOP

Format HC, EC

QA-1008

5

HC, EC

Change Control SOP

QA-3001

3

1. QA Filling 2. QMS > General > SOP 1. QA Filling 2. QMS > General > SOP

Initial/Date

HC, EC

*Refer to Appendix A for “Format” abbreviation definitions. Comments:

The information above has been reviewed and verified as correct. Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 10 of 25 3.2.2 Equipment

In the sections below, record the identification of each document, version, number, location, and format as outlined in the “SOP for Solid Dosage Manufacturing and Production Laboratory Equipment Documentation” (QA-1011). Each item listed is to be verified by including the initials and date of the reviewer responsible. Document Title PTF E/ER Purchase Order

Doc. # QA4081

Version 1

PTF E/ER Design Qualification PTF E/ER User Manual

DQ1001 QA4011

1

PTF E/ER Materials of Construction Certifications

QA4051

1

1

Location 1. QA Filling 2. QMS > Orders > Scans 1. QMS > Engineering 1. QA Filling 2. QMS > Equipment > SD-005 > Scans 1. QA Filling 2. QMS > Engineering

Format HC, SC

Initial/Date

HC, EC HC, SC

HC, SC

*Refer to Appendix A for “Format” abbreviation definitions. Comments:


Date: ______________

Reviewed By: ______________________________________

Date: ______________



Measuring Devices

In the sections below, record all measuring devices used in execution and tests of the installation, operation, and performance qualifications. Each device must be identified with their identification number, calibration certification reference, and current and due calibration dates as outlined in the “General Documentation SOP” (QA -1008). Each item listed is to be verified by including the initials and date of the reviewer responsible. Equipment

ID #.

Calibration Certification Reference

Last Calibration Date

Next Calibration Due Date

Initial/Date

Tachometer Stop Watch Power Cord Connection

Comments:


Date: ______________

Reviewed By: ______________________________________

Date: ______________


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 12 of 25 3.4 Training

In the sections below, record the name of the individual, type of training, and reference to training certification, and date of training as outlined in the “General Documentation SOP” (QA 1008). Each item listed is to be verified by including the initials of the individual who is associated with the training. Individual

Type of Training

Reference to Training Certification

Date of Training

Initial/Da te

Comments:


Date: ______________

Reviewed By: ______________________________________

Date: ______________



Instructions for Execution

4.1 General Instructions When executing the protocol, the following instructions must be followed: 4.1.1 Training: All personnel involved in the execution of any step(s) in the protocol must be trained. Training must be included on the “Training” page and verified with the personnel’s signature and initials , as recor ded on the “Signatures” page in this protocol. 4.1.2 Data Entry: 1. All step(s) of the protocol must be recorded in accordance to the applicable regulatory, divisional/departmental requirements, cGMP and GMPs, as outlined in the “SOP for Solid Dosage Manufacturing and Production Laboratory Equipment Documentation ” (QA-1011) and “General Documentation SOP” (QA-1008). 2. All items on a form are to be completed in full, with the exception of the optional comment’s section. 3. Blank data entry spaces and blank “Comment” sections are to be strike through with a single bottom left to upper right diagonal line, designated with the letters N/A [Not Applicable], initialed and dated by the personnel responsible for data completion. 4. Document any deviation from defined protocols and expected results. Approval of protocol deviations must be documented before final approval signatures can be obtained, as outlined in the “General Documentation SOP” (QA-1008) and “Change Control SOP” (QA-3001). 5. If there is not enough space on the form to accommodate all comments, additional information may be included on addendum page(s) after: 5.1 The addendum page(s) are numbered alphanumerically. 5.2 The addendum page(s) are initialized and dated. 5.3 The addendum page(s) are included proceeding the original page. Refer to Appendix B for Addendum Attachment Page. 6. Short and long corrections are to be complete as outlined in the General Documentation SOP (QA-1008). 4.2 Special Pre-cautions When executing the protocol, the following special pre-cautions and safety recommendations should be followed: 1. Do not use the device with a damaged power cord connection (broken case, poor contact, and broken feed cable) or if the label information has been misplaced/damaged. In addition, if suspected internal damaged to the main unit (cracked case, leakage of electrolyte, off-shape, etc…), contact the manufacturer. 2. Ensure that electrical outlet(s) are appropriate and compatible with the equipment’s power cord connection. 3. Ensure that the power switch on the rear panel is in the “OFF” position prior to attaching the power cord connection to the unit. 4. Avoid exposure to strong electrical fields from nearby equipment or utilities.



Actual Execution

The execution of installation qualification protocol will be recorded in the format and will fulfill the overall objective of installing Pharma Test Auto-Friability Tester (PTF E/ER) through the verification of packaging and shipping containers, parts and components, clearance, utilities, environmental conditions, and correct installation.



Visual Inspection and Verification

6.1

Packaging and Shipping

When executing the visual inspection of packaging and shipping containers prior to installation of the PTF E/ER, the equipment unit and components are present and are at acceptable conditions as defined in the “PTF E/ER User Manual” (QA-4011). Condition

Pass / Fail / N/A

Initial/Date

External packaging material conforms to manufacturer ’s specification. External packaging material is free of any physical or chemical defects. Internal packaging material for equipment and components conforms to manufacturer ’s specifications. Internal packaging material is free of any physical or chemical defects. All information regarding packaging and shipping details are referenced and documented with purchase order document. Storage location prior to installation was free of any factors that would result in physical or chemical defects.

Comments:


Date: ______________

Reviewed By: ______________________________________

Date: ______________



Parts and Components

When executing visual inspection and verification, the equipment unit and components are present and are in the acceptable conditions as defined in the “PTF E/ER User Manual” (QA4011) and “PTF E/ER Materials of Construction Certifications ” (QA-4051). Equipment Model: PTF E/ER

Serial Number:

Description Main Unit

QTY 1

Condition

Plexiglas-Roche Drum, 10mm axis diameter, right side ver. Plexiglas-Roche Drum, 10mm axis diameter, left side ver. Drum Lock Nut

1

2

Power Cord Cable

1

Instruction Manual

1

Test Report

1

Warranty – Certificate

1

Initial/Date

1

Comments:


Date: ______________

Reviewed By: ______________________________________

Date: ______________



Utilities and Environment

When executing visual inspection and verification, all utilities and environmental conditions are acceptable as defined in the “Utilities Requirements” of the Pharma Test Auto -Friability Tester (PTF E/ER) Installation Qualification Protocol. Clearance: Verify that the bench top clearance necessary for operation have been met and in conformance with design qualifications and/or manufacturer’s specifications. Defined Condition(s)

Available Condition(s)

Suitability of Condition(s)

Comments

Initial/Date

(Minimum) 10cm rear clearance (Minimum) 10cm side clearance (Total) 60cm Bench Space Bench space is clean, dry and level (Minimum) Bench space can support 30 kg Electrical: Verify that the electrical outlet(s) and connections necessary for operation have been met and in conformance with design qualifications and/or manufacturer’s specifications. Defined Condition(s)



Comments

Initial/Date

110V-230V (Frequency 50-60 Hz) Environmental: Verify that the environmental necessary for operation have been met and in conformance with environmental and/or manufacturer’s specifications. Defined Condition(s)



Comments

Initial/Date

Temperature: +20 oC to +40 oC Humidity: no less than 80% rF The information above has been reviewed and verified as correct. Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________



Hook Up and Instrumentation

For more detailed instructions, refer to the user manual PTF E/ER User Manual (QA-4011). 1. Remove the PTF E/ER unit and all components from the packaging material. Visually inspect for evidence of any physical or chemical defects. Pass

Fail

N/A

Comments:

Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

2. Remove the protective film from inside the Plexiglas Drum(s). Visually inspect for evidence of any physical defects (scratches and chips, static, dust- accumulation, etc…). Pass

Fail

N/A

Comments:

Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

3. Install the Plexiglas Drum(s) by aligning the two parts of the drum together. Locate the proper orientation of the drum to the respective side of PTF E/ER unit. Pass

Fail

N/A

Comments:

Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 19 of 25

4. Attach the Plexiglas Drum(s) to the PTF E/ER unit with the Lock Nut(s). Ensure that the drum(s) are secured to the alignment mechanism on the respective sides of PTF E/ER unit. Pass

Fail

N/A

Comments:

Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

5. Ensure that the power switch on the rear panel is in the “OFF” position. Ensure electrical outlet(s) prior to attaching the power cord cable to the unit are appropriate and compatible with the unit. Pass

Fail

N/A

Comments:

Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

6. Attach the power cord cable to the unit. Then the attach power cord cable to electrical outlet. Pass

Fail

N/A

Comments:

Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 20 of 25

7. Turn the “Mains Switch” on the rear panel to the “ON” position. The 10mm 4-digit LED display should light up immediately and show the actual operating mode. Pass

Fail

N/A

Comments:

The information above has been executed, reviewed and verified as correct. Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________



Deviations and Non-Standard Occurrences

If any deviations occur during the Installation Qualification Protocol, record the deviation ID that references the deviation report as well as a brief description of the deviation and investigation findings below. All deviations and non-standard occurrences are to be handled under the defined investigation procedures and CAPA systems. The date the corrective actions will be included upon approval and implementation. Corrective actions will be verified by the initials and date of the personnel responsible, as stated in each deviation report. The Installation Qualification Protocol cannot be approved and completed unless all outstanding deviation are approved and closed. Deviation ID:

Description of Deviation

Investigation findings

CAPA completed:

Initial/Date

Comments:


Date: ______________

Reviewed By: ______________________________________

Date: ______________



Conclusion

The approval and competition of this Installation Qualification protocol indicates the requirements and planned actions relating to all components, systems, and functionality associated with the installation of the Pharma Test Auto-Friability Tester have been met and complies with the validation policy requirements, as stated in the Validation Master Plan (Doc #: VPM-100), and the applicable sections of the cGMP and GMP guidelines. Equipment validation can proceed for testing under the approved Operational Qualification Protocol.


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 23 of 25 Execution Approval Signatures below indicate that the appropriate individuals have reviewed the executed document and found the results of the execution to be acceptable.

This equipment is now approved for testing under the approved Operational Qualification Protocol. 1. Reviewers’ Signature: Typed/Printed Name, Title

Signature

Date

Signature

Date

2. Approvers’ Signature: Typed/Printed Name, Title

Quality Assurance Manager

Production Manager

Validation/ Engineering Manager


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 24 of 25 Appendix A Format Abbreviation Definitions Abbreviation HC

Full Term Hard Copy

 

SC

Scanned Copy



 

EC

Electronic Copy

  

Description The official documentation Used for investigations, regulatory inspections, and auditing purposes The scanned/photocopied version of the official documentation Used for routine operations and quality functions Includes an indication of a “COPY” status, dated and initialed The editable version of the documentation Used for routine operations and quality functions Includes the audit trail with the current implemented version and release date


2055 Notre Dame Avenue, Winnipeg, Manitoba, Canada Pharma Test Auto-Friability Tester (PTF E/ER) Installation Qualification Protocol Department: Validation Author: James Y. Huang Page 25 of 25 Appendix B Addendum Attachment Page IQ Section:

Page # - Letter:

Additional Comments:

The information above has been reviewed and verified as correct. Reviewed By: ______________________________________

Date: ______________

Friability Tester IQ Protocol

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