The regulatory certification of pharmaceutical laboratories is constantly evolving with the increasing requirements for the safety and reliability of human drugs. The US FDA 21 CFR Part 11, European GMP annex 15, and US Pharmacopeia General Rules<1058>（Analytical Instrument Qualification，AIQFor GxP pharmaceutical factories and laboratories, compliance requires documentation proving that the analytical instruments used are calibrated and operated according to their operating procedures during delivery, installation, and use.

Do all instruments require confirmation of analytical instruments? This involves the classification of analytical instruments. Referring to USP<1058>, laboratory instruments can be divided into three categories: A, B, and C, and the certification items used for different categories of instruments are also different.

Class ANot equipped with measurement function, or usually only requiring calibration, the supplier's technical standards can serve as user requirements. For example: ultrasonic cleaning machine, centrifuge, shaker, etc.

Class BThis type of instrument has measurement functions, and the physical parameters controlled by the instrument (such as temperature, pressure, etc.) need to be calibrated. User requirements are generally the same as the supplier's functional standards and operating limits. For example, melting point meters, analytical balances, pH meters, etc. This type of instrument usually requires installation certification and operation certification, as well as the development of standard procedures for operation, calibration, and maintenance.

Class CThis type of instrument usually consists of instrument hardware and computer control system (firmware or software), and users need to provide detailed descriptions of the instrument's functional requirements, operating parameter requirements, system configuration requirements, etc. For example, liquid chromatography and infrared spectroscopyPreparation of liquid chromatography systemUnified. This type of instrument requires installation certification, operation certification, and specialized performance certification, as well as the development of standard procedures for operation, calibration, and maintenance.

liquid chromatographyThe authentication scheme should include four parts, namely 4Q, which are:

DQ， Design QualificationConfirm that the design of the equipment complies with user requirements specifications and relevant regulations.

IQ， Installation QualificationConfirm that the instrument files, components, and installation process comply with the specifications.

OQ， Operational QualificationConfirm that the instrument can operate normally within the operating limit when in idle state.

PQ， Performance QualificationConfirm whether the instrument meets the standard requirements during sample loading operation.

Due to the fact that all instruments used in the laboratory are developed and designed by instrument manufacturers, DQ certification can be omitted in instrument certification. The commonly referred to 3Q certification refers to IQ, OQ, and PQ above. That is to say, laboratory instrument validation starts with IQ, followed by OQ and PQ, to complete a complete set of instrument validation data.

When do I need IQ and OQ certification?

After the installation of all new instruments, software upgrades, instrument transfers, and major instrument repairs (such as replacements)Liquid phase high-pressure pump）.

Who is responsible for completing IQ, OQ, PQ?

IQ and OQ projects are completed by qualified engineers arranged by the manufacturer, while PQ projects can be completed by specific users,Some manufacturersCorresponding services can also be providedreference standardAnd confirmation service (PQ).

What specific steps are required for each step of 3Q verification?

IQ (Installation Certification), as the name suggests, refers to the confirmation (or verification) of the installation process of an instrument, confirming that the instrument complies with the design and regulations, is installed correctly, and is suitable for the environment. It needs to be completed by qualified certified engineers.

Firstly, prepare paper documents and list them in the form of tables, including proof materials from instrument manufacturers regarding instrument materials, testing principles, etc; The instruction manual, packaging list, accessory list and other materials provided by the instrument manufacturer; Calibration certificates for instruments or other components, etc. Next is the verification of the preparation work for the external environment, such as temperature and humidity control, power supply, etc. The next step is to verify the components of the instrument itself. Based on the instructions and the characteristics of the instrument itself, check whether the above preparation work is completed and reasonable.

2. OQ (Operational Qualification) needs to be completed by qualified engineers,. The main purpose is to verify that the instrument can operate well within the limits of the instrument design, which is a validation of small and large limit experiments. During this process, many measuring devices need to be used here to confirm some of the instrument's functions, such aspressureWe need to use an external temperature device to verify the design of the instrument itselfpressureAnd lowpressureIs it within the design scope. Computer operation verification, including display, instrument software version, and operation manual. Complete system testing, analyzing the signal reproducibility and baseline offset of validated sample testing instruments through IQOQ testing.

3. PQ (Performance Qualification) can be completed by specific users. For instruments, this step can be simply understood as OQ (Operational Qualification) of standard samples, because this step involves conducting experiments with samples of known concentrations to verify the accuracy of the instrument; There are samples of unknown concentration to verify the detection capability of the instrument, etc. Simply put, it is the process of testing once or twice according to the sample testing method. Generally speaking, once IQ (installation certification) and OQ (operation certification) are completed, PQ (performance certification) can be successfully passed.
Shanghai Hanyao Instrument Equipment Co., Ltd