PQExample PDF
PQExample PDF
Performance Qualification
Written By:
Approved By:
Validation Coordinator
Laboratory Manager
Process Engineer
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.
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.
18/12/07 Page # 2
Protocol #: PQP-xxx Ver 01
Performance Qualification
IQ Status
Installation Qualification has been successfully completed. Refer to report # IQR ..
OQ/PQ Status
Operational/Performance Qualification has been successfully completed. Refer to report # OQR
..
Equipment List
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.
18/12/07 Page # 3
Protocol #: PQP-xxx Ver 01
Performance Qualification
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 List Process Instructions # and List Products manufactured at this step
Reference Version for the steps
Process Variables Machine (Line) speed, seal dwell time, warm up time of sealer, Pouch width,
(Factors) operator(s), .
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.
Sample and Test Describe the sampling plans for each run (number, location, frequency etc)
Plan 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 Statistical methods in SOP 3-x-x will be used as appropriate to analyse the data.
Criteria** 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.
18/12/07 Page # 4
Protocol #: PQP-xxx Ver 01
Performance Qualification
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.
18/12/07 Page # 5
Protocol #: PQP-xxx Ver 01
Performance Qualification
6 Example PQ Report
18/12/07 Page # 6