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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 Name, Title
James Y. Huang,
Validation Lead

Signature

Date

2. 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 Name, Title

Signature

Date

3. 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 Name, Title

Quality Assurance Manager

Production Manager

Validation/ Engineering
Manager

Signature

Date

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 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]

2015.02.12

Specific details with the Pharma Test Auto-Friability


Tester PTF E/ER from user manual [Doc. #: N/A]

2015.02.27

Revised from N. Schepp comments and


recommendations

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

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 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: ______________

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 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.

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 7 of 25
2. Responsibilities

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

Quality
Assurance

General Responsibilities

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

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 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.

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 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

HC, EC

Change Control SOP

QA-3001

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: ______________

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 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

PTF E/ER Materials of


Construction
Certifications

QA4051

Location
1. QA Filling
2. QMS > Orders >
Scans
1. QMS > Engineering

Format
HC, SC

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

HC, SC

Initial/Date

HC, EC

HC, SC

*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: ______________

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 11 of 25
3.3

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:

The information above has been reviewed and verified as correct.


Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

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 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 (QA1008). 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:

The information above has been reviewed and verified as correct.


Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

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 13 of 25
4.

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 personnels signature and initials,
as recorded 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
comments 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 equipments
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.

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 14 of 25
5.

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.

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 15 of 25
6.

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 manufacturers


specification.
External packaging material is free of any physical or chemical
defects.
Internal packaging material for equipment and components
conforms to manufacturers 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:

The information above has been reviewed and verified as correct.


Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

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 16 of 25
6.2

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

Power Cord Cable

Instruction Manual

Test Report

Warranty Certificate

Initial/Date

Comments:

The information above has been reviewed and verified as correct.


Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

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 17 of 25
6.3

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 manufacturers 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 manufacturers specifications.
Defined Condition(s)

Available
Condition(s)

Suitability of
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 manufacturers specifications.
Defined Condition(s)

Available
Condition(s)

Suitability of
Condition(s)

Comments

Initial/Date

Temperature: +20oC 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: ______________

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 18 of 25
7.

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: ______________

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 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: ______________

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 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: ______________

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 21 of 25
8.

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 Description of Deviation
ID:

Investigation findings

CAPA
Initial/Date
completed:

Comments:

The information above has been reviewed and verified as correct.


Executed By: ______________________________________

Date: ______________

Reviewed By: ______________________________________

Date: ______________

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 22 of 25
9.

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.

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 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

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 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

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 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: ______________

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