I. 4Q Verification

1. Definition

“4Q Verification” is also called “4Q Confirmation”. It is a method commonly used by the domestic and foreign pharmaceutical industries to verify instruments. “4Q Verification” completes the verification of instruments through 4 steps. Since the abbreviations of these 4 steps all contain the letter Q (Qualification), it is called “4Q Verification”.

4Q Verification stands for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

2. Role of 4Q Verification

(1) Design Qualification (DQ)

Design Qualification is carried out before the purchase of equipment. It mainly confirms whether the functionality and operating indicators of the instrument meet the intended use of the instrument, and uses this as the standard for selecting the instrument supplier.

(2) Installation Qualification (IQ)

Installation Qualification is carried out during the installation phase of the equipment. It mainly confirms whether the received instrument meets the selection requirements and can be correctly installed and used normally in the specified environment. (3) Operational Qualification (OQ)

Operational Qualification is carried out during the equipment acceptance phase or after major equipment repairs, modifications or relocations. It mainly confirms whether the equipment can operate normally in the selected environment according to the functions shown in the operating instructions and whether the operating technical indicators meet the design requirements.

(4) Performance Qualification (PQ)

Performance Qualification is generally carried out during the daily operation of the equipment. It mainly confirms whether the performance of the instrument under normal use conditions can always be consistent with the instructions.

Calibration of luggage instruments

II. 4Q Verification Method and Implementation

Suppose that a laboratory is preparing to purchase a device for calibration work for a new project in order to expand its business. This process usually requires steps such as demand research, procurement, installation, acceptance, and verification during use. The following takes this as an example to briefly explain the application of 4Q verification in laboratory equipment management.

1. Design Confirmation

Design confirmation is generally carried out in the following steps: collecting URS (User requirements specification, URS) - URS confirmation - supplier selection - URS submission and response - supplier confirmation - procurement.

(1) Collection of URS

The specific implementation department of the project proposes various indicators of the equipment to be purchased, such as functional indicators, operating indicators, environmental impact indicators, structure and appearance, laboratory environment, software, etc., based on the actual conditions of the laboratory and the expected use of the equipment to be purchased, and forms a URS document, which is submitted to the equipment procurement department.

(2) Confirmation of URS

The equipment procurement department verifies the URS submitted by the implementation department and performs review, countersignature, approval and other procedures in accordance with the laboratory management regulations.

(3) Supplier selection

The equipment procurement department submits the URS to the equipment supplier (or solicits suppliers from the public through bidding procedures). During the specific implementation, the laboratory should determine whether the purchase requires bidding based on factors such as the purchase amount and the nature of the laboratory, and select the procurement method and channel according to the confirmation results.

(4) Verification and response of URS

The supplier conducts design verification based on the URS, and the verification content includes various indicators such as functional indicators, operating indicators, environmental impact indicators, noise, electrical system and control functions, safety protection indicators, key part materials, interface relationship with equipment and related public facilities, structure and appearance, computer system, laboratory environment, etc. Some tests may need to be performed in a specific laboratory environment (software). The supplier should feedback the verification documents generated to the equipment procurement department.

(5) Supplier confirmation

The equipment procurement department selects suppliers based on the verification documents fed back by the supplier, comprehensive laboratory environment, usage requirements and other relevant factors, and needs to evaluate the supplier's installation, service and training capabilities at the same time.

(6) Procurement

The equipment procurement department implements equipment procurement in accordance with the relevant laboratory management regulations. In this step, try to stipulate the installation, traceability, follow-up service and training of the equipment in the contract.