포바이오코리아

FAQ

Testing request
Other

QHow much sample is required for test analysis?

As it differs depending on the test item or test protocol, it is decided through consultation
QWhat documents are required for the testing request?

A test request form and a signed estimate or contract
QWhat about the testing procedure?

Through consultation, we issue a quotation and receive a request form, and after delivery of the sample and payment,
we conduct the test. The testing deadline is different for each test. When the analysis is completed, a report can be issued.
QIn the case of self-testing report, is it possible to issue a report for the purpose of quality inspection?

In the case of a test registered in the Korean Pharmacopoeia, it is possible for the purpose of quality inspection, and a self-testing report can be submitted for the purpose of “other (reference)”.
QIf sponsor information is changed after the end of the whole request procedure including issuing report, is it possible to reissue the report for the changed sponsor name?

Changes cannot be made to the contents of a report that has already been issued. However, before the report is issued, there are some parts that can be changed through consultation.
QWhat about the list of testing to be conducted in FBK?

You can find them in Quality testing Service > “MFDS-accredited testing list” or >”Pharma BDS/DP Quality testing” menu on our homepage. It is indicated in our own analytical test or the Ministry of Food and Drug Safety (MFDS) certification test. In the case of missing items, please contact us through the ‘inquiry for testing request’. After checking the test method, it is necessary to check whether the test is possible or not with a person in charge of the test in FBK.
QWhat is the standard to distinguish the Ministry of Food and Drug Safety (MFDS) -accredited testing from the self-testing among the quality testing services?

Only the tests per dosage form accredited by MFDS belong to ‘MFDS-accredited testing list and all the others are ‘self-testing’.
QWhat dosage forms are available for testing?

In the case of liquid formulations, injections and irrigation agents, and eye drops among pharmaceuticals, only those approved by the Ministry of Food and Drug Safety are issued a report from MFDS or tested for reference (purpose). In the case of other tests (self-testing), we are conducting tests for reference (purpose).

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