Professional Documents
Culture Documents
Friability Tester IQ Protocol
Friability Tester IQ Protocol
Friability Tester IQ 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
Prepared By:
James Yuchen Huang
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
Production Manager
Validation/ Engineering
Manager
Signature
Date
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
Revision
Date
2015.02.06
2015.02.12
2015.02.27
Revised
By
James
Y.
Huang
James
Y.
Huang
James
Y.
Huang
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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:
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
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
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
Equipment Function
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
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
QA-3001
1. QA Filling
2. QMS > General >
SOP
1. QA Filling
2. QMS > General >
SOP
Initial/Date
HC, EC
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
DQ1001
QA4011
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
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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:
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
6.1
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
Comments:
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
Instruction Manual
Test Report
Warranty Certificate
Initial/Date
Comments:
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
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: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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:
Date: ______________
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:
Date: ______________
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:
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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:
Date: ______________
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:
Date: ______________
Date: ______________
6. Attach the power cord cable to the unit. Then the attach power cord cable to electrical outlet.
Pass
Fail
N/A
Comments:
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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:
Date: ______________
Date: ______________
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
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
Production Manager
Validation/ Engineering
Manager
Doc. #: IQ-1001
Rev. #: 3
Effective Date: 2015.03.05
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
Page # - Letter:
Additional Comments:
Date: ______________