The 3Q verification of analytical instruments is not a new topic, but since the domestic pharmaceutical industry has been neglecting the product quality system for a long time, we are quite strange and confused about the content of each certification. This article will analyze the instrument. The various verifications are summarized and a key strategy is proposed for the advanced reference of the pharmaceutical industry. The pharmaceutical factory to buy a drug stability test box must find a company that can report 3Q, the simple household can help you succeed, but you can do 3Q to do a few, Germany imported ice can be, the domestic equipment company in 3Q is simple The household is more perfect and in place.
To buy a good drug test box, please go to Shanghai Jianhao Instrument Co., Ltd., you can log in to the Jane Instrument Mall, the best service, the best product, the best price, where is the production and sales of drug stability test box, or Shanghai Jane The instrument is good.
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Overview
Strictly speaking, in the process of manufacturing and manufacturing, the drug needs to be confirmed through layers to confirm that the safety and quality of the drug is indeed effective and reliable. To achieve such a goal, it must be related to various productions. Matters, a series of scientific assessments, including a variety of instruments, analytical methods, support systems and manufacturing process validation, and we collectively refer to these processes as Validation. In other words, the confirmation is a process of scientific evaluation and written recording of all related items of the product. Therefore, the verification of the instrument is only a part of the effective operation. The purpose is to ensure that the instrument is in the process of use. The design requirements and the intended purpose are to produce reliable measurement results.
In order to meet the above requirements, we must design a prudent Qualification plan and an effective Test method; but first we must emphasize that verification and testing are not the same, verification is focused on evaluation Whether the system operates as expected, its focus is on verifying that the file is complete and correct, while testing refers to the identification of errors in the system, with an emphasis on assessing the difference between the predicted and actual results. Therefore, we can say that the verification includes the test; and a complete instrument verification plan usually contains three parts, which are familiar to us: installation verification IQ, operation verification OQ and performance verification PQ.
Inclusion of instrument verification
At the user's level, reasonable instrument verification should include the above three processes, but in fact, before the instrument leaves the factory, it must pass the so-called Design and Development Qualification (DQ) to truly pass the qualified instrument. Test, as shown in Table 1:
Table 1, 4Q relationship table
design
----→
installation
----→
Adjustment
----→
Boot
----→
use
----→
Design and
Development
Qualification
(DQ)
Design and development verification
Installation
Qualification
(IQ)
Installation verification
Operational
Qualification
(OQ)
Operational verification
Performance
Qualification
(PQ)
Performance verification
Therefore, we clearly understand that from the above figure, the three stages of the entire validation are distinguished. The DQ part is completely the work of the instrument supplier, and the IQ/OQ must be jointly participated by the supplier and the user. As for the PQ It should be done by the user and the order of execution cannot be reversed.
IQ/OQ phase
Why is there such a difference? First of all, we must understand the most important contents of IQ: the identification of various related documents of the instrument and the installation environment of the instrument; only the establishment of the identity of the instrument and the appropriate installation under the limited conditions, The instrument can be used by the operation, and these confirmed actions should be carried out by the supplier and the user. Finally, when the instrument is installed, the responsible supplier will perform the on-site installation test of the instrument, and the original design specifications. After the comparison, the test report is issued as the last document of IQ, and at the same time, the instrument can enter the confirmation phase of OQ. If the position of the instrument does not move later, the installed body part does not need to be in principle. Perform IQ verification.
OQ mainly confirms that the instrument can operate normally within the limits of operation. Therefore, it is necessary to select individual and key operation groups of the instrument for confirmation, such as individual buttons and individual controllers. During the confirmation process, the instrument is used. The supplier instructs the user to gradually learn the operation of the verified instrument. This process is equivalent to teaching the machine. When all the buttons and controllers are verified, the user should theoretically learn to operate the instrument at the same time, and for the instrument. The operational limitations of the operation have a holistic concept, so the OQ phase is still to be completed by the supplier and the user; when the individual operation of the instrument--confirmation is correct, it indicates that the instrument has entered the stage of formal use. In the future, a certain time schedule must be arranged to perform routine verification on some OQ items. If the instrument has moved, repaired, replaced the main components or added accessories, the OQ of the instrument must be routinely verified.
PQ stage
The confirmation of PQ is mainly to check whether the overall performance of the instrument is normal by running the machine or loading the simulated drugs. Why is there such a procedure? Because even if the individual operation functions of the instrument are confirmed, the instrument is officially used. During the experiment, there may be some differences between the experimental results and the expected conditions, and it is not guaranteed that the results of the overall experiment will be correct. The main reason is that the results of the experiment, in addition to the instrument performance factors, the user for the sample The preparation, the experimental techniques, and the feasibility of the experimental methods are sufficient to accumulate different degrees of deviation, resulting in the failure of the experimental results, so PQ must first confirm the IQ and OQ before confirming (control change) In order to ensure the reliability of the experimental procedures and instrument operation, the PQ must be completed by the user independently, and when the new experimental method and the new operator are generated, a PQ confirmation must be made; The relationship between 3Q and its verification is listed in Table 2.
Table 2. Requirements for instrument verification under various conditions
-
DQ
IQ
OQ
PQ
Before purchasing
※
-
-
-
installing
-
※
-
-
installing
-
-
※
※
In operation
-
-
Note 2
※
In operation
-
Note 1
※
※
Hardware part update or add accessories
section
section
section
※
Hardware update
section
-
※
Hardware update
Note three
section
Note three
※
Migrate device
-
section
※
※
New operator replacement
-
-
-
※
New use
※
-
Note 4
※
To buy a good drug test box, please go to Shanghai Jianhao Instrument Co., Ltd., you can log in to the Jane Instrument Mall, the best service, the best product, the best price, where is the production and sales of drug stability test box, or Shanghai Jane The instrument is good.
Buy an environmental test box and find a simple household.
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