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Does the influencing factor test of tablets need to be put naked and packed

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the basic requirements of stability test are:
(1) stability test includes influencing factor test, accelerated test and long-term test. The influencing factors were tested with one batch of API. Accelerated test and long-term test shall be conducted with 3 batches of test articles. (2) The test substance of API shall be produced on a certain scale, the amount of test substance is equivalent to the batch required by the preparation stability test, and the synthetic process route, method and steps of API shall be consistent with the mass production. The test article of drug preparation shall be the product of scale-up test, and its prescription and production process shall be consistent with that of mass production. For pharmaceutical preparations such as tablets and capsules, the scale of each batch of amplification test shall be at least 10000 tablets and 10000 capsules. For preparations packaged in large volume, such as intravenous infusion, the quantity of each batch of enlarged scale shall be at least 10 times of the total amount required for each test. The quantity required for special varieties and special dosage forms shall be determined separately according to the situation
(3) the quality standard of the test article shall be consistent with the quality standard of the test article used in preclinical research, clinical trial and large-scale production
(4) the packaging of the test article used in the accelerated test and long-term test shall be consistent with the products on the market
(5) to study drug stability, it is necessary to adopt specific, accurate, precise and sensitive drug analysis methods and inspection methods for related substances (including degradation products and products generated by other changes), and verify the methods to ensure the reliability of drug stability test results. In the stability test,
attention should be paid to the inspection of degradation products. (6) Since the number of scale-up tests is smaller than that of large-scale production, the applicant shall promise to carry out accelerated test and long-term stability test for the three batches of large-scale production products that initially passed the production verification when they are transferred from scale-up test to large-scale production after obtaining the approval. Baoyuantong drug stability test box

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