Scribd
Upload
332 views

PQ-example Guidelis Sample

The document outlines a performance qualification protocol for validating a new heat sealer. It details the purpose, reference documents, pre-requisites, equipment list, experimental plan, sample and test plan, acceptance criteria, and signature record required for the validation. The experimental plan involves running trials under different operating conditions and measuring seal strength to ensure specifications are met.

Uploaded by

asit_m
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
332 views

PQ-example Guidelis Sample

The document outlines a performance qualification protocol for validating a new heat sealer. It details the purpose, reference documents, pre-requisites, equipment list, experimental plan, sample and test plan, acceptance criteria, and signature record required for the validation. The experimental plan involves running trials under different operating conditions and measuring seal strength to ensure specifications are met.

Uploaded by

asit_m
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

Performance Qualification

Protocol #: PQP- xxx Ver 01


Gismo Heat Sealer
Page 1 of 6
SeerPharma Pty Ltd Page # 1
Performance Qualification Protocol
Prepared March 2008
Title Heat Sealer Validation
Products Sterile Gizmos Codes 12345 through 12789
Equipment/Process to be Validated: Supplier Co., Model xyz, ABC Manufacturing Equipment
Register: MER 98-1248 / Heat Sealing Process: SOP 20-
12-14
Equipment Number PPCN 98-364
Approval of the Validation Protocol
Sign here after reviewing and approving the document, standards and schedules
Title Name Signature Date
Written By:
Approved By:
Validation Coordinator
Laboratory Manager
Technical/ Quality Assurance
Manager
Process Engineer
Performance Qualification
Protocol #: PQP-xxx Ver 01
Gismo Heat Sealer
Page 2 of 6
18/12/07 Page # 2
1 Section 1: Purpose
Supplier Co. has developed a new and improved heat sealer, which should improve process flow
and reduce setup time. The heat sealer will be validated to assure it performs with existing barrier
pouch materials and existing process procedure SOP 20-12-14. SOP 20-12-14 identifies a design
requirement for a seal strength of 2 to 4 kg and a target of 3 kg. The most difficult pouches to seal
are the smallest (PN 96-122) and the largest (PN 88-010). The target process capability is a Cpk of
>1.33.
2 Section 2: Reference Documents
1. Heat Seal Process Procedure, SOP 20-12-14
2. Statistical Methodologies, SOP 3-8-51, SOP 3-9-12, SOP 3-13-81
3. Master Device Records, Codes 12xxx
4. Manufacturing Equipment Register, MER 98-1248
5. Supplier Co. Model xyz Heat Sealer Operating Manual
6. Process Validation Master Plan: PVP-98001
7. Lab Processes and Calibration: SOP 9-2-5
8. Production Processes and Calibration: SOP 20-1-2
9. Clean Room Procedures: SOP 1-12-77
3 Performance Qualification Pre-requisites
The sealer must pass IQ and OQ phases of qualification before commencing the performance
qualification phase.
In addition interim or proposed manufacturing instructions should be drafted and approved, all
measuring instruments should be calibrated, the sealer should pass a safety inspection and
operators trained in the manufacturing instructions.
Performance Qualification
Protocol #: PQP-xxx Ver 01
Gismo Heat Sealer
Page 3 of 6
18/12/07 Page # 3
IQ Status
Installation Qualification has been successfully completed. Refer to report # IQR ..
Name Signature Date
OQ/PQ Status
Operational/Performance Qualification has been successfully completed. Refer to report # OQR
..
Name Signature Date
Equipment List
Measurement / Testing Equipment and Calibration:
1. Stopwatch, Process Development Lab, Calibrated per SOP 9-2-5
2. Remote IR Thermometer RST-12, Process Development Lab, Calibrated per SOP 9-2-5
3. Pressure gauge, 0 500kPa, Process Development Lab, Calibrated per SOP 9-2-5
4. VAR meter, ID 683, Process Development Lab, Calibrated per SOP 9-2-5
5. Heat Seal Pull Tester, PE 8167, Production, Calibrated per SOP 20-1-2
Performance Qualification Conditions
Performance Qualification will commence after satisfactory completion of installation and
operational qualification.
The normal production process will be used. Production personnel will be trained on the use of the
new heat sealer. Worst case combinations of time, temperature and pressure will be evaluated.
Optimal settings for the heat sealer will be used and the heat seal action levels for adjustment of
time, temperature and pressure will be used.
Performance Qualification
Protocol #: PQP-xxx Ver 01
Gismo Heat Sealer
Page 4 of 6
18/12/07 Page # 4
4 Performance Qualification Experimental Plan
Aim
To provide documented evidence that the bag heat sealing step is capable and
reliable and can consistently manufacture products that meet pre-approved
specifications.
Procedure
Reference
List Process Instructions # and
Version for the steps
List Products manufactured at this step
# of Experimental
Runs (default = 3
Run #1 Lot #: Date: Where:
Run #2 Lot #: Date: Where:
Run #3 Lot #: Date: Where:
Process Variables
(Factors)
Machine (Line) speed, seal dwell time, warm up time of sealer, Pouch width,
operator(s), .
Process Measures:
Monitor and Record Expected Operating Ranges
List the process Seal Dwell Time 30.0 sec 45.0 sec
parameters Sealer Temperature 200oC 250oC
to be measured Sealer Pressure 1.0 bar 1.5 bar
during the run Line Speed 40 / hour - 60/ hour
Operator(s) Use at least 2 different operators
Experimental
Details
Describe the
experimental
approach for each
run:
Runs will be completed as follows:
1) with the optimal settings per the Device Master Record target conditions -
repeat 2 times
2) with a short dwell time (30 sec), low temperature (200oC) and low pressure
(1.0bar); repeat 2 times
3) long dwell time (45sec), high temperature (250oC) and high pressure (1.5bar).
repeat 2 times.
Action levels for adjustment of the heat sealer will be determined as a result of this
phase.
Conduct each run with at least 300 bags.
Sample and Test
Plan
Describe the sampling plans for each run (number, location, frequency etc)
Sample size: 3 consecutive bags per time
Sample frequency: every 15 minutes, also 10 at start and last 10 bags
Test: Subject each sample to the seal integrity challenge test SOP xxx
Acceptance
Criteria**
Statistical methods in SOP 3-x-x will be used as appropriate to analyse the data.
1. Seal strength Cpk must be greater than 1.33 across each run.
2. Al sampled bags must be within acceptance limits 2.0Kg to 4.0Kg
** If any run does not meet the accept criteria raise a validation deviation notice.
Performance Qualification
Protocol #: PQP-xxx Ver 01
Gismo Heat Sealer
Page 5 of 6
18/12/07 Page # 5
5 Signature Record
All personnel involved in this qualification must complete the table below to provide identification of
all the signatures/initials used in this document.
Company Title Name & Signature Initials &
Date
Performance Qualification
Protocol #: PQP-xxx Ver 01
Gismo Heat Sealer
Page 6 of 6
18/12/07 Page # 6
6 Example PQ Report

You might also like