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How to properly accept standard products?

2019-11-27 15:18:31

Standard products, that is, standard items, are the Chinese medicine standard reference products research center agent as a measure; When used as a drug, it is the standard content in the content determination. Standards include stoichiometric standards, metallurgical standards and drug testing standards. So how to properly accept the standard? The following is a small edition of Bolinda to introduce you.


1. Acceptance content


When the laboratory has the need to purchase standard materials/standard samples, it needs to develop a "standard materials/standard samples procurement plan" and be approved. "Standard material/Standard sample procurement Plan" shall at least include: standard material/standard sample name, number, specification, quantity, etc.


When the laboratory accepts the purchased standard material/standard sample, in addition to checking the relevant information against the "standard material/standard sample procurement plan" to confirm compliance with the requirements of the "standard material/standard sample procurement Plan", it is also necessary to check the integrity (or sealing degree) of the packaging and logo, and the correspondence between the certificate and the physical object. When applicable, it should also check the characteristic value, uncertainty, matrix composition, expiration date, storage conditions, safety protection, special transportation requirements and other contents indicated in the certificate.


For standard materials/standard samples with special transportation requirements such as low temperature, the transportation status should be checked when feasible.


If necessary and feasible, suitable experimental means can be used to confirm the characteristic quantity value, uncertainty, matrix composition and other characteristics of the standard material/standard sample.


When the manufacturer or batch of the same standard material/standard sample is changed, the laboratory can compare the old and new standard material/standard sample, which can verify the stability of the characteristic quantity value of the old standard material/standard sample, and also confirm that the new standard material/standard sample meets the requirements of use.


When the reference material/reference sample is used for calibration, method validation, quantity value transfer and traceability, the certified reference material/reference sample should be used as far as possible.


2. Acceptance personnel


In general, the standard material/standard sample manager or user should be involved in the acceptance work.


3. Acceptance records


The laboratory shall record the necessary acceptance contents in the acceptance contents. When applicable, the acceptance record of the standard material/standard sample generally includes: name, number, batch number, packaging, identification, certificate, characteristic quantity, uncertainty, expiration date, purchase date, purchase quantity, manufacturer, acceptor, acceptance conclusion, etc. If the test method is used for experimental acceptance, there should be relevant information and records of the test method, test result and measurement uncertainty at the time of acceptance.


4. Acceptance conclusion


Acceptance of the standard material/standard sample can be put into use. After the user receives it, the laboratory shall be properly managed according to the storage conditions and storage period specified in the certificate.


Acceptance of unqualified standard material/standard sample, can not be used.


The above content is the introduction to the correct acceptance of standard products. The laboratory needs to establish the procurement, acceptance, storage and use of standard substances/standard samples, and implement the system of receiving registration.


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