10个回答
产品的批量在批生产记录上,取样/留样/稳定性样品等数量在批生产记录中可进行追溯;产品放行的数量在产品检验报告上,出具4000更为合理 ,同时查询了WHO关于COA模板的规定,里边提到的为quantity received,个人理解应为发货的数量或入库的数量,供参考。
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WHO TRS 902, Annex 10, 2002 Model certificate of analysis
The certificate should include:
- The name and address of the laboratory performing the tests.
- The registration number of the certificate of analysis.
- The name, description (i.e. grade, quantity received, type of container) and number (used by the original manufacturer and repacker/trader) of the batch for which the certificate is issued, the date of manufacture, and the expiry date (or retest date).
- The date on which the batch for which the certificate is issued was received.
- A reference to the test procedure used, including the acceptance criteria (limits).
- The results of all tests performed on the batch for which the certificate is issued (in numerical form, where applicable) and a comparison with the established acceptance criteria (limits).
- Any additional test results obtained on samples from the batch as part of a periodic statistically based testing programme.
- A statement indicating whether the results were found to comply with the requirements.
- The date(s) on which the test(s) was (were) performed.
- The signature of the head of the laboratory or an authorized person.
- The name, address, and telephone and fax numbers of the original manufacturer. If supplied by repackers or traders, the certificate should show the name, address, and telephone and fax numbers of the repacker/trader and a reference to the original manufacturer.
- A statement of the expected conditions of shipping, packaging, storage and distribution, deviation from which would invalidate the certificate.
- A copy of the certificate generated by the original manufacturer, if the sample is supplied by a repacker or trader.
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