Qualification is documented evidence that all the equipment, system, facility, or utility are designed, installed, and operated in such a way that complies with GMP requirements and produces products of the desired quality all the time. Qualification is a part of validation and consists of following
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification(PQ)
If we discuss in a detailed manner then some key factors are also the part of qualification which are as follow,
- User Requirement Specifications(URS)
- Factory Assessment Test( FAT)
- Site Acceptance Test ( SAT)
- To understand the qualification system i will try to explain it with a simple example which is as follow,
- For a specific job, a specifically qualified person is required.
- For example in the pharmaceutical industry for the post of Production Pharmacist, the qualification of a person should be Pharm D.
- Only that person will qualify for the post who have required qualification because if we hire a person with different qualifications we will not be able to achieve the desired results.
- In the same way, any new equipment, area, facility or utility should only be used for a task in pharmaceutical industries if it is qualified for that specific purpose
Now the question is what should be the qualification of equipment or an area?
Who sets the qualification criteria for equipment, area, system,facility or utility?
Answer of this question is very simple that
For this we have the URS.
URS (User Requirement Specification)
- URS is a document that defines the requirement for use of equipment, system utility or facility.
- The first step for purchasing new equipment or to build an area or system is the required specifications for that by the concerned department.
- For that, a document is prepared which contains all the requirements which we need for equipment or facility.
- This document is called URS and it is sent to the supply chain department.
- The supply chain department finds a suitable vendor against that URS.
- The audit of the vendor should be conducted and the vendor should be qualified.
- Everyone in daily life prepares URS for routine purchasing but it may not be in a written form.
- For example, when we want to purchase a mobile phone we decide which type of features should be present in that mobile phone e.g RAM size, storage memory,Battery storage, Screen Size etc.
- We prefer to purchase a mobile phone from a reputable shop.
- In the same way for pharmaceutical purchasing of any equipment first, we prepare URS in written form which contains required features and then we send URS to the supply chain department.
- Supply chain department sends this URS to the vendor.
URS will include all the requirements which are as follow
- Capacity Requirements.
- Design Requirements like dimensions, MOC.
- Software Requirements.
- Safety Requirements.
- Cleaning Requirements.
- Operational Requirements.
- Power Consumption.
- Working Accuracy.
- Lubrication Requirements.
Suppose we want to buy a Bin Blender for mixing area in the pharmaceutical industry.
URS for Bin Blender will include
- The dimension of Bin Blender according to our area where it is to be installed.
- The material of construction like 304,304L or 316 or 316L.
- Software Design and PLC to control the Blender parameters like a touch screen with a graphical view etc.
- For operation, it should have a maximum 30 rpm, baffles installed and pneumatic feeding system.
- For safety, it should have a safety frame and frame opening alarm.
- For Cleaning it should have a CIP system installed.
- For power consumption, proper electrical wiring requirement and horse-power of the motor is given.
Design Qualification (DQ)
- Design qualification is documented evidence that the required equipment system, facility or utility is designed according to the URS.
- After preparing a URS by the user and its delivery to the vendor, the vendor prepares a Design document according to the URS mentioning all the requirements of the user in technical format and it is sent back to the end-user.
- Users carefully read every point and match it to URS and make changes if any.
- If all the requirements are according to the URS then this document is signed and the purchase order is generated and sent to the vendor.
- DQ allows vendors to start manufacturing.
- Design qualification is mutual understanding and agreement on the defined Design of equipment or system by both vendor and user.
FAT (Factory Acceptance Test)
- FAT is a Factory Acceptance Test.
- When DQ is completed and the vendor starts to manufacture the equipment the end-user visits the vendor facility to ensure that all the working is carried out according to URS and DQ.
- End users also inspect the functions and operation of equipment at the vendor site before dispatch to ensure that equipment is according to URS and DQ.
SAT (Site Acceptance Test)
- SAT is a site acceptance test.
- SAT is Performed at a user site.
- When equipment arrives at the target place it is inspected by the user to ensure that there is no damage to the equipment during transportation.
- Its dimension and specification are the same as mentioned in DQ and URS.
- It is fit for installation.
It is documented evidence that the required equipment, facility or utility is installed according to the design requirements and URS.
URS may include the following,
- Identification of equipment,make, model number, serial number etc.
- In Installation qualification, it is verified that the equipment is properly installed and occupies proper space according to DQ.
- All the connections are made properly.
- Installation does not create hindrance to work.
- Verify that all the safety features are properly installed according to Design Qualification and URS.
- Verify all the cleaning methods.
- Verify all the spare parts and components.
- Verify specific documentation e.g equipment manual, SOPs etc.
- Verify drawing.
- Cables and connectors.
- Verify calibration records.
- Verify MOC.
To understand installation qualification take an example of Bin Blender.
- After SAT Bin Blender is installed in a mixing area.
- All the electrical supplies are checked that they are properly connected.
- Safety alarm is checked that it is installed.
- All the spare parts are verified.
- MOC (Material of construction) has verified according to the URS that it is 316L.
- It is ensured that all the manuals and drawing are provided by the vendor.
- After installation qualification, the equipment, facility or utility is ready for operational qualification.
- Operational qualification is documented evidence that the required equipment, facility or utility works according to requirements.
- Operational qualification is checking the operation of each component of equipment.
- Operational qualification is performed without load means in empty or as built conditions with supplies and connections etc.
- Different ranges and parameters are checked.
- Low medium and high ranges are verified.
- Verify working of safety parameters.
- Operational SOPs are available.
- Personnel training.
- Assure that calibration, cleaning and operational parameters are satisfactory.
To understand the operational qualification take an example of a Bin Blender which is previously installed according to Design qualification.
As we know that in OQ we test the components of equipment without load and verify different operational ranges.
So we will check rpm of the empty Bin Blender.
We will note the following
- rpm at the lowest speed
- rpm at medium speed
- rpm at highest speed
Working of safety alarm is checked that either it is operational or not.
Check that the cleaning procedures are according to requirements.
- Performance qualification is documented evidence that the specific equipment, system or utility is working properly to give desired results under real working conditions.
- Performance Qualification is carried out under load.
- We ensure that the equipment which gives acceptable results without load will produce the same results under load.
- Placebo batch is run to get results under load.
- A Bin Blender which is previously installed in an area and is qualified in the operational stage is tested for performance qualification.
- We run the equipment in real working conditions under load to check that all components produce the same results as in the empty pass stage.
- In the bin blender, a placebo batch is added and its rpm are noted as in OQ.
- Safety features are checked during working conditions.