Qualification
Prepared by: Rejina Ghimire
Introduction
• It is the action of providing and documenting that equipment or
ancillary system are properly installed ,work accurately lead to the
expected results.
• Qualification is part of validation but individual qualification steps
alone do not constitute process validation.
• Qualification of analytical instrumentation is essential for accurate
and precise measurement of analytical data.
Requirement for qualification
• Whether or not specific equipment, systems, require qualification
depends on its application. Qualification is performed for new
equipment/facility/utility.
• After major breakdown in equipment /facility/utility.
• After modification in equipment /facility/ utility.
• For change /extension of qualification range.
• Periodic requalification.
Requalification
• It ensures that the equipment is still in qualified state after a change
and periodical assessment of equipment within defined time
intervals.
• Requalification is required if change in:-
Change in batch size significantly .
change in operating parameters.
change in component or materials specifications.
change in new accessories or components are added to qualified equipments.
process changes that potentially can effect qualification.
Benefits of qualification
• Make process better understood.
• Reduce the risk of problems
• Assure the smooth running of the processes.
• Control of the product quality.
• Reduce the variation of outcome.
• Reduce the defect and maintenance cost.
• Easy maintenance and safety.
• To improve the overall production reliability and availability.
• Reduce the chances of failure and product recall.
• Result in reduced time to market for new product.
Phases of qualification
• Qualification of instrument has been grouped into four phases:-
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Design qualification
• It is the documented verification that the proposed design of the facilities ,system and
equipment is suitable for intended purpose.
• It should be performed into two phases:
I. When new equipment is being purchased .
II. existing equipment is being use for new process.
• Design qualification as precursor to defining equipment installation and operational
qualification.
• It contains:-
• Description of equipment
• References:
• Specification
• Quotation
• Order number
• Machine specifications.
• Approvals/ authorization.
• Manuals.
• Certifications.
Installation qualification
• It is documented evidence that the premises ,supporting utilities ,the
equipment have been built and installed incompliance with design
specification.
• It verifies that the equipment has been installed in accordance with
manufacturer recommendation in a proper manner and placed in an
environment suitable for intended purpose.
• It involves the coordination efforts of vendor ,the operating
department and the product team.
Operational qualification
• Operation qualification is the process of demonstrating that an
instrument will function according to its operational specification which
results in product of predetermined requirement.
• Operational Qualification typically includes performance tests,
functionality tests, and stress tests to evaluate the equipment
capabilities under different operating conditions.
• Operational Qualification shall be performed to verify that the
equipment, instrument, utility and system, operates in accordance with
design specification, manufacturer recommendations and cGMP
requirements.
• Operational Qualification contains :
1. Equipment operating principles.
2. Methodology for operational qualifications.
3. Training to personnel for maintenance and operation.
4. Process control limits (e.g. time, temperature, pressure, setup conditions.)
5. Process change control, short term stability and capability of the process.
6. Process operating procedures, material handling requirements.
7. Calibration review of critical instruments.
8. Testing of safety features and interlocks.
Performance qualification
• After IQ and OQ ,The instrument continue suitability for its intended
use is provided through performance qualification.
• It refers to establishing evidence that the process ,under anticipated
condition ,consistently produces a product which meet all
predetermined requirement.
• Performance Qualification includes:
Acceptability of products.
Process repeatability, long term process stability.
Assurance of Process capability and established in operational qualifications.
Actual product and process parameters and procedures established in
operational qualifications.
Qualification of manufacturing
equipment
• Validation of solid dosage form (tablets)
1. Validation of raw material:
o Variation occurs among different suppliers of the same product
o Exposure of materials to undesirable conditions and transportation.
2. Check physical and chemical characteristics.
3. Mixture
o Validation of capacity.
4. Shifter
o Size of sieves must be validated.
5. Fluidized bed dryer
o Check inlet and outlet thermometers.
6. Blender
7. Compression machine
8. D T apparatus
9. Friability apparatus
10. Balances
Qualification of analytical
instruments
• AIQ: collection of documented
evidence that the instrument
Quality control check performs suitably for its intended
samples use.
• Analytical method validation: It is
the collection of documented
System suitability tests evidence that an analytical
procedure is suitable for its intended
use.
Analytical method
• System suitability tests: It verify that
validation
the system will perform in
accordance with the criteria set forth
Analytical instrument in the procedure.
qualification • Quality control check samples: It
help to ensure the quality of
analytical results immediately.
Qualification of Laboratory
Equipment:
• The equipment validation process covers the following steps:
a. Customer requirement
b. Preparation design qualification and its certification
c. Installation qualification
d. Operational qualification
e. performance qualification
a) Customer requirements:
• Customer and user of the equipment has certain expectation regarding the
equipments
a) Customer requirements:
• Customer and user of the equipment has certain expectation regarding the
equipments
b) Preparation of DQ:
• Identification of various stages during the fabrication of equipment.
• visual ,instrumental, or physiochemical testing are performed.
c) Installation qualification:
• The equipment can only be installed when it passes IQ test.
d) Operational qualification:
• The equipment should be operated only when it passes OQ test.
e) Performance qualification:
• Here the equipment should perform well.