What is GMP Qualification?
Qualification is the verification through documented activities that an instrument, process equipment, or process facility involved in manufacturing and quality control of medicinal products is properly designed and installed and operates within predefined specifications.
What is the purpose of GMP Qualification?
The purpose of qualifying process equipment or analytical instruments is to verify suitability for the intended use and to ensure that process equipment, devices or facilities meet their specifications and the associated acceptance criteria as defined and specified.
General Principles and Practices
- GMP Qualification is an intricate process consisting of four main phases: DQ, IQ, OQ, and PQ. Qualification is part of validation. Equipment, instruments, systems, and devices are qualified, processes, procedures, and methods are validated.
Design Qualification (DQ)
- The selection and purchase of a new instrument, process equipment, or process facility shall follow a documented decision process. The decision is based on the needs related to the intended purpose.
General DQ activities
I Planning
- Design stage
- URS, FS
- System Classification
- Risk Assessment
II Procurement
III Suppliers Work
- FAT
- SAT
Installation Qualification (IQ)
- The IQ verifies the correct implementation of the requirements defined in the design qualification (DQ) during the assembly and installation of the equipment. The verification of the installation qualification (IQ) is basically performed on the basis of the previously devised URS.
General IQ activities
- Instrument delivery
- Description
- Utilities/Facility/Environment
- Assembly and installation
- Software installation, network, and data storage
- Installation verification
Operational Qualification (OQ)
- OQ verifies that the process equipment, process facility, or analytical instrument operates within its specified operational specifications as designed and installed.
- OQ follows the IQ
- OQ verifies the URS
- FAT and SAT should be incorporated into testing activities to avoid retesting
Performance Qualification (PQ)
- PQ verifies that the process equipment, process facility, or analytical instrument operates consistently and reproducibly within predefined performance specifications and acceptance criteria under actual conditions of use.
- PQ therefore ensures the fitness for purpose of the process equipment or process facility under actual conditions of use.
User Requirement Specifications (URS)
User requirements and system specifications are devised in the User Requirements Specification (URS). The user requirements refer to the laboratory needs and the technical and operational requirements of the system.
Specifications must solve every part of the problem described in the URS. Requirements and specifications must be testable.
The URS is an essential regulatory GMP document which is directly linked to risk assessment and qualification. The devise of a thorough and intelligent URS is of utmost avail as the URS influences directly the outcome of the qualification process.
Instrument Calibration
Calibration is a test procedure to establish the relationship between the output and input variables, i.e. the measured value and the corresponding true or correct value using a reference standard to identify the deviation of a test device (e.g. test instrument, analytical instrument, system).
FAT
For complex process line or process facilities the framework is extended to include functional specifications (FS) and factory acceptance testing (FAT). FAT is performed by and at the vendor’s location. The primary objective is to ensure that the system meets the functional and operational specifications as devised in the URS. FAT may include all activities from commissioning to qualification (DQ, IQ, OQ). FAT should be incorporated into the qualification operations where possible.
SAT
Site acceptance testing (SAT) includes analytical instrument installation, process equipment installation and start-up which are normally undertaken in IQ and OQ. The equipment is retested when installed at the manufacturing site by the vendor. Some of the SAT activities may be satisfied and do not need to be repeated by the manufacturer. The documentation can be incorporated into the qualification process.
Summary
The use of qualified instruments is mandatory and part of good manufacturing practices (GMP) as required by regulatory authorities such as the U.S. Food & Drug Administration (FDA) or European Medicines Agency (EMA).
The purpose of qualification and validation is to contribute to customers’ confidence that the instruments and equipment perform suitably according to their intended use.
For GMP-related environments such as the pharmaceutical industry and treatment centers for ATMPs, qualification and validation are essential GMP requirements to confirm GMP compliance.