Qualification refers to activities undertaken to demonstrate that utility and equipment are suitable for their intended use and performing properly.
Qualification Definition: It is the action of providing and documenting that equipment or ancillary systems are properly installed, work correctly, and accurately leading to the expected results.
Qualification is a part of validation but individual qualification alone does not constitute process validation.
Qualification of Analytical Instruments
Qualification of analytical instrumentation is essential for accurate and precise measurements of the analytical data.
(if an instrument is not qualified, all other work based upon the use of that instrument is suspect.)
Types of Qualifications in Pharmaceuticals
Qualification of instruments has been grouped into 4 phases as follows:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance qualification (PQ)
Design Qualification (DQ):
Design Qualification is the documented verification that the proposed design of the facilities, system, and equipment is suitable for the intended purpose.
When to Perform DQ: DQ should be performed— When new equipment is being purchased, and Existing equipment is being used for a new process.
Design qualification is a design demonstration according to GMP compliance, and all details shall be mentioned in the user requirements specification (URS) as follows:
- Product and requirements
- Process and operation requirements
- Operating ranges
- GMP, Operation, and safety requirements
The principle of design should be such to achieve the objectives of GMP concerning equipment. Mechanical drawings and design features provided by the manufacturer of the equipment should be considered for examination.
Installation qualification (IQ):
Installation qualification is documented evidence that the premises, supporting utility, the equipment have been built and installed in compliance with design specifications.
It verifies that the equipment has been installed as per the manufacturer’s recommendation in a proper manner and placed in an environment suitable for the intended purposes.
When to Perform IQ: must be applied to new or changed facilities, systems, and instrumentality. The following main points should be included in the installation qualification.
- Checking of installation of equipment, piping, services, and instrumentation.
- Collection of supplier’s operating working instructions and maintenance requirements and their calibration requirements.
- Verification of materials for construction
- Sources of spares and maintenance.
Operational Qualification (OQ):
Operational Qualification is the process of demonstrating that an instrument will function according to its operational specifications which results in a product of predetermined requirements.
It must include the following:
- Testing developed from the knowledge of the processes systems to cover upper and lower limits, and Sometimes these are called ‘worst case conditions.
- Calibrate measuring device
- Operation and cleaning procedure
- OQ report preparation
Performance Qualification (PQ):
After performing IQ and OQ, the instrument’s continued suitability for its intended use is provided through performance Qualification. It refers to established evidence that the process under anticipated conditions, consistently produces a product that meets all predetermined requirements. following successive Qualifications that must be completed as PQ.
PQ should include the following:
- Testing using production materials, substitutes, or simulated products. These can be developed from the knowledge of the process and facilities, systems, or equipment.
Component Qualification (CQ): CQ developed a new term in 2005. the main aim is to ensure ancillary components are manufactured to the correct design criteria, including secondary packing materials like cartons, shipping case labels, and inserts.
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