PERFORMANCE QUALIFICATION

Jakarta, 15-16
September, year 2015
Speaker: MIMI VIRLANY SYAHPUTRI

1
 VALIDATION V-Model
•User •PQ
D
Requirement ß Is based on
E
S
•Specification
I
G
N
•Functional •OQ
Q •Specification ß Is based on
U
A
L
I
F
I
•Design
C
A
•Specification ß Is based on •IQ
T
I
O
N
•IMPLEMENTATION
PERFORMANCE QUALIFICATION
Documented evaluation of the system to show that the
system operates as intended throughout the anticipated
operating ranges, under conditions as close as possible to
normal production

Various functional checks on the equipment, generally

performed using actual product.

PQ work should be performed on systems whose

performance or process parameters are critical and could
affect the quality of the product.
EXAMPLES
• URS mentioned :
• Mixing tank should equipped with Cleaning In Place System
• Sprays cover all surface area with no dead spot with hot water supply
facilities

• Vendor Design Specification

• Mixing thank equipped with spray ball with 20 sprinkle holes

• Vendor Functional Specification

• Spray ball able to move down 50cm
• Spray ball rotate 5 – 15 RPM during spraying
• Spray pattern covers all surfaces tank
• Spray stage : potable water+detergent à potable water à Purified water
• Valve for hot water supply avaible
EXAMPLES
• IQ
• PI&D check and verification

• OQ
• Verify movement
• Verify rotation (5 to 15 RPM)
• Verify Spray Pattern (with fluorescence material if
needed)
• Verify Spray Stages
• Verify hot water supply
EXAMPLES
• URS mentioned :
• Mixing tank should equipped with Cleaning In Place System
• Sprays cover all surface area with no dead spot with hot water supply
facilities
• PQ
• Show equipment that able to clean product marker (most potent and most
difficult to clean
• To eliminate the residue below the allowable limit
By defining
• Optimum spray ball position
• Spray pressure and rotation speed
• Soaking process
• Cleaning step and timeline
PERFORMANCE QUALIFICATION
Pre-conditions for PQ execution:
• OQ-reports must be approved
• PQ-protocols must be approved
• Equipment / system has to be officially released for PQ
• Pre-conditions defined in VMP and PQ documents have
to be fulfilled (e.g. SOP's, start up of system, etc.)

PQ testing work will be taken by the user's personnel, not

by vendors or outside contractors responsible for installing
and commissioning of the system
PERFORMANCE QUALIFICATION vs
PROCESS VALIDATION
• PQ has two elements:
• (1) is the design of the facility and qualification of the equipment
and utilities and
• (2) is the process performance qualification (PPQ). which
combines the actual facility, utilities, equipment (each now
qualified), and the trained personnel with the commercial
manufacturing process, control procedures, and components to
produce commercial batches, and will confirm the process
design and demonstrate that the commercial manufacturing
process performs as expected
(US FDA Process Validation Guidance)
PERFORMANCE QUALIFICATION vs
PROCESS VALIDATION
• Can be performed together during process validation
• Matrix/bracketing approach could be accepted more on
filling/packing machinery
• Highest volume – Lowest Volume
• Largest packed size – smallest packed size

Important to understand process and its criticality

• Vial sterile filling vs bottle filling
• Powder for OS vs Powder for external use
CONTENT OF PQ DOCUMENT
• Purpose
• Description
• References
• Responsibilities
• Identification of personnel
• Performance qualification test plan/result and acceptance
criteria
• Modifications/change control and revalidation
• Deviations and corrective actions
• Performance Qualification Summary
• Approval of PQ Report
• PQ attachments

10
CONTENT OF PQ DOCUMENT
• PQ attachments
• Calibration of validation test instruments
• List SOP
• Deviations – List
• Deviations – Corrective Actions
• Change Control List
• Identification of Personnel

11
DEVIATION DURING
PERFORMANCE QUALIFICATION
• Back to initial QRM
• Safety
• GMP/Regulation
• Business
• Review the impact (direct/indirect/no
impact)
àCan the deviation justified?
àCan we add additional preventive measure on
certain parameter that failed to meet?
àCan we drop the requirement?
12
DEVIATION DURING
PERFORMANCE QUALIFICATION
(CONT’D)
• Managed by deviation, should change
needed raise change control
(project/existing change control system)
• Should improvement need to made, re-
qualification on particular aspect can be
performed (review the impact of change)
• Should any CAPAs needed, those need to
be maintained as norm of CAPA handling

13
DOCUMENTATION
• Important key à no jeopardize in product quality
• Summary report and raw data must tally
• All reference document as properly cross-
referenced (risk assessment, deviation, change
control, etc.)
• Retrievable and traceable
• Sequential
• Ensure GEP, GDocP and data integrity all the time

14
15