Food GMP certification was initiated by the United States in the 1960s, which means GOOD MANUFACTURING PRACTICE. The World Health Organization defines GMP as the regulations that guide the production and quality management of food, drugs and medical products.
GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries, requiring enterprises from raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects according to the relevant national regulations to meet the health quality requirements, the formation of a set of operational norms to help enterprises improve the health environment of enterprises, timely discovery of problems in the production process, to improve. In brief, GMP requires pharmaceutical, food and other production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product (including food safety and hygiene) meets the requirements of regulations. Drug GMP certification is a system for the state to implement GMP supervision and inspection of drug manufacturers (workshops) and drug varieties and obtain recognition. Although the international concept of drugs includes veterinary drugs, only a few countries, such as China and Australia, separate GMP for human use and veterinary drug.
What is GMP related to FAT, SAT, DQ, IQ, OQ, PQ verification? Why is it necessary?
In the fields of biopharmaceutical, food processing and scientific research experiments, pulverized preparation production line is an important processing means, and the verification process of its equipment is very important. This process not only ensures the stability and safety of the product quality, but also complies with the strict requirements of the international GMP (Good Manufacturing Practice) and industry standards. FAT (Factory Acceptance Test), SAT (Site Acceptance Test),
DQ (Design Qualification) IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) verification, Five key links are indispensable in this process.
FAT (Factory Acceptance Test) : Factory acceptance test
FAT is the first comprehensive test carried out in the factory of the manufacturer of the crushing product line to verify that the equipment complies with the established technical specifications and quality standards during the design and manufacturing phase. This stage includes mechanical operation inspection, electrical safety testing, control system verification and performance parameter testing to ensure that the equipment meets the predetermined requirements before leaving the factory. The successful completion of FAT is a prerequisite for the successful delivery and commissioning of the equipment, reducing subsequent problems caused by equipment defects.
SAT (Site Acceptance Test) : site acceptance test
SAT follows FAT after the equipment has been shipped to the customer site and installed. This step is to check whether the device is damaged during transportation and installation, and ensure that the onsite installation conditions, such as power supply and environment control, meet the device running requirements. The SAT also involves revalidation of the basic functions of the device to ensure that it can still function properly in the new working environment, laying the foundation for subsequent IQ, OQ, and PQ verification.
DQ (Design Qualification) : Design qualification
The DQ stage is mainly carried out before the purchase of the instrument, the purpose is to select the instrument according to its own needs, and confirm that the instrument design meets the expected use requirements and the relevant requirements of GMP (Good manufacturing Practice for pharmaceutical products). This process involves a thorough review and evaluation of the instrument design to ensure that it can meet the expected performance standards and conditions of use.
In the pharmaceutical industry, DQ validation is particularly important because it is directly related to whether a device can meet the specific needs and standards of pharmaceutical production. Through DQ verification, you can ensure that the design of the selected equipment can support the subsequent production process, thus guaranteeing the quality and safety of the product. In addition, DQ verification is also the foundation of the entire verification process, providing a solid foundation and clear direction for the subsequent IQ, OQ and PQ stages.
IQ (Installation Qualification) : installation qualification
IQ is an official confirmation of the freeze-drying machine installation process and installation environment. It covers the review of equipment installation documents, confirmation of installation location, inspection of power supply and grounding system, and verification of the integrity and identification of equipment components. The purpose of IQ is to ensure that the equipment has been correctly installed according to the manufacturer's requirements and the customer's site conditions, providing the basis for the subsequent operation and performance verification of the equipment.
Operational Qualification (OQ) : Operational qualification
In the OQ stage, the focus is on verifying the ability of the freeze-dryer to operate under preset operating conditions. This includes responsive testing of operations such as starting, stopping and emergency shutdown of the equipment, as well as functional verification of key components such as control systems, sensors and alarm systems. OQ simulates the operation scenarios in the actual production process to ensure that the equipment can operate in the expected manner and meet production requirements.
PQ (Performance Qualification) : Performance qualification
PQ is the most critical step in the validation process, which directly assesses the actual performance of the pulverized preparation line under specific production conditions and the conformity of product quality. PQ usually involves the operation of multiple production cycles, monitoring and recording changes in key process parameters (such as temperature, pressure, time), and the detection of product quality (such as appearance, water content, active ingredient content, etc.). The successful completion of PQ indicates that all the grinding mechanisms in the production line have fully met the design requirements, and can be used stably and reliably to produce high-quality products.
This series of verification processes together build a comprehensive quality control system from the factory to the use of the equipment, ensuring the stable operation and efficient output of the grinding product line throughout the life cycle. Through strict verification, enterprises can effectively reduce the risk of production interruption caused by equipment failure, improve product quality stability, enhance customer trust, and thus occupy a favorable position in the fierce market competition. At the same time, it also meets the strict regulatory requirements for the quality and safety of drugs, food and other products worldwide, which is an important guarantee for the sustainable development of enterprises. Our Fangyuan Machinery grinding preparation production lines have met the requirements of GMP production specifications, and perfectly support the "4Q" acceptance requirements.
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