Customers often ask about the drug stability test box validation scheme here!
First of all, the purpose of our verification is to prove that the equipment can meet the needs of production process, meet the requirements of equipment performance, meet the requirements of the product factory standards and product delivery standards through a series of activities such as DQ (design validation), FAT (manufacturing factory validation), IO (installation validation), PQ (performance validation). National GMP requirements.
IO (Installation Confirmation), QC (Operation Confirmation) and PQ (Performance Confirmation) are commonly used and include these.
1. IO (Installation Confirmation)
The purpose is to provide a series of test data through verification activities to prove that the installation documents, installation conditions and installation results of the test box meet the design requirements, and the data and documents meet the GMP management requirements.
The contents of confirmation are as follows:
A. Confirmation of random documents (e.g. packing list instructions, etc.)
B. Confirmation of open-box inspection of equipment
C. Confirmation of Equipment Installation Conditions
D. Confirmation of equipment installation results
2. QC (Operation Confirmation)
The purpose is to check and test the operation technical parameters of the equipment, confirm that the operation performance of the equipment can meet the design requirements and meet the relevant requirements of GMP. The contents of confirmation are: confirmation of instruments and meters.
3. PQ (Performance Validation)
The purpose is to check the technical parameters of the equipment, confirm that the local load performance meets the design requirements and meets the relevant requirements of GMP.
The contents of confirmation are as follows:
A. Accuracy of control of equipment under load operation
B. Other performance indicators of the equipment under load operation; whether the uniformity and fluctuation of temperature and humidity meet the relevant requirements of GMP.
ZenSan Mechatronics Science and Technology has focused on the production and manufacture of drug stability test boxes for ten years. It provides drug stability test boxes, drug strong light stability test boxes, drug comprehensive test boxes, step-in stability test labs, constant temperature and humidity test boxes, high and low temperature test boxes, culture boxes, drying boxes and resistance furnaces, oscillators, purifying boxes. Equipment, environmental test box and laboratory analytical instrument series.
