URS--DQ--FAT--SAT--IQ--OQ--PQ
Qualification is a very important and critical topic in pharma. URS, DQ, FAT , SAT, IQ, OQ, and PQ has all unique significance in pharma.
As per PIC/S (PI 006-3)
QUALIFICATION:
Identification of equipment attribute related to the performance of a particular or functions and allocation of certain limits or restrictions to those attributes.
The activity to prove with appropriate documentation that any of area, system or equipment are properly installed and or work appropriately to lead the expected result.
URS: User Requirement Specification
User requirement specification is to provide appropriate design and performance requirements for procurement of any equipment/system/instrument/utility including major add-on component or major modification/expansion of area to meet in-house requirement as well as complies with cGMP.
The requirement for preparation of URS shall be evaluated at initial stage i.e. during procurement phase
URS is an authorized document which consist the list of requirements prepared by the user for the particular instrument/equipment/component or utility, to be purchased.
All URS Component Shall Verify:
- Design Specification ( Dimensions, Capacity, Hardware, Software etc.)
- Accuracy
- Cleaning Requirement
- Function Requirements
- Safety Features
- Controls
- Power Consumptions
- Etc.
DQ: Design Qualification
Design qualification is a documented evidence the premises, supporting systems, utilities , equipment and processes have been designed in accordance with the requirement of good manufacturing practices. The requirements of the URS should be verified during the design qualification.
The Documented verification that the proposed design of the facility, system, equipment or utility is as per proposed URS and suitable for intended purpose.
In design qualification same component of URS should be to ensure that ongoing design process is same as per our URS or not.
FAT: Factory Acceptance Test
Factory acceptance test is a way to ensure that the equipment/system/utility being purchased meet the agreed upon design specification.
Ideally this happens before arriving at customer's site ,however, for complex system with high integration test may need to be performed at customer's location.
In factory acceptance test DQ component shall be verify.
SAT: Site Acceptance Test
Site Acceptance Testing (SAT) provides an opportunity for final confirmation that the performance experienced during thefactory acceptance testis repeated after the systems are installed onsite, ensuring nothing has changed or was damaged during shipment and installation. This process typically involves full functional testing of the machines/equipment after they are installed and integrated with support systems.
In site acceptance test DQ component shall be verify.
IQ: Installation Qualification
The Installation Qualification (IQ) execution; verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications. It further details a list of all the cGMP requirements that are applicable to this particular installation qualification. These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of theOQ.
- Verification that all components parts.
- Verify installation is as specified.
- Insert a brief description of what part of the validatedproduct process.
- Insert a brief description of theoperational function.
- Verify supply voltages.
- Verify thatelectrical installation qualification (IQ).
- Verify that all alarms and visual displays.
- Identify and verify serial number & model number.
- Review allcalibration certificate.
- Verify that the ambient conditions.
- Verify that the documentation for maintenanceof the system.
- Verify the safety features.
OQ: Operational Qualification
Operational qualification can be defined as, the compilation of pragmatic that a process can consistently produce regulatory controlled product to within predetermined specification.
The Instrument equipment/Instrument/system/utilities should operate in accordance with their design specification.
Component of operational qualification
- Operation of functional key.
- Operation of alarm and interlock system.
- Operation of sequential parameter/off Switches.
- Alarm.
- Temperature.
PQ: Performance Qualification
Performance qualification in establishing confidence through appropriate with documented evidence that the finalized product or process meets all release requirement for the functionality and safety and those procedure are effective and reproducible.
Documented verification that the Instrument equipment/Instrument/system/utilities operates consistently and gives reproducibility within defined specification and parameter for prolonged periods.
All Instrument equipment/Instrument/system/utilities must go for Re-Qualification.
- Periodically
- On any major or critical changes
