回答：
WHO GMP 通则 - 2014/06[10]
17.16 In lieu of full testing by the manufacturer, a certificate of analysis may be accepted from the supplier, provided that the manufacturer establishes the reliability of the supplier's analysis through appropriate periodic validation of the supplier's test results (see sections 8.8 and 8.9) and through on-site audits of the supplier's capabilities. (This does not affect section 17.15.) Certificates must be originals (not photocopies) or otherwise have their authenticity assured. Certificates must contain at least the following information (7):
- (a) identification (name and address) of the issuing supplier;
- (b) signature of the competent official, and statement of his or her qualifications;
- (c) the name of the material tested;
- (d) the batch number of the material tested;
- (e) the specifications and methods used;
- (f) the test results obtained;
- (g) the date of testing
- WHO ECSPP TRS 1010 Annex 4 Model certificate of analysis - 2018/05[11]
According to WHO good practices for pharmaceutical quality control laboratories (2) the CoA lists tests performed on a particular sample with the results obtained and the acceptance criteria applied, followed by an indication of whether or not the sample complies with the specification. A CoA is usually prepared for each batch of a substance or product and should include the following information:
- – the name and address of the laboratory issuing the CoA;
- – the identification number of the CoA and on each page an identification, the page number and the total number of pages to ensure that every page is recognized as a part of the certificate;
- – the name, address and contact person representing the originator of the request for analysis;
- – the number assigned to the sample by the laboratory during registration upon receipt;
- – the date on which the sample was received in the laboratory and the quantity of sample (number of units or packages);
- – the name, description (for example, active ingredient, dosage form, strength, package size in the case of FPPs; grade in the case of starting materials; type and material of the primary packaging), batch number (used by the original manufacturer and repacker or trader) of the sample for which the certificate is issued, the expiry date (or retest date, where applicable) and date of manufacture (if available);
- – the name and address of the original manufacturer; in addition, if supplied by repackers or traders, the certificate should show the name and address of the repacker or trader;
- – specifications for testing and a reference to the test procedure(s) used, including the acceptance criteria (limits);
- – the results of all tests performed on the sample for which the certificate is issued (in numerical form, where applicable) and a comparison with the established acceptance criteria (limits); results of tests performed by subcontractors should be identified as such;
- – any comments, observations or information on specific test conditions, where these are necessary for the interpretation of the results;
- – a conclusion as to whether or not the sample was found to be within the limits of the specification;
- – the date and signature of the head of the laboratory or other authorized person approving the certificate.
参照中国GMP 第二百二十三条
（六）检验记录应当至少包括以下内容：
1. 产品或物料的名称、剂型、规格、批号或供货批号，必要时注明供应商和生产商（如不同）的名称或来源；
2. 依据的质量标准和检验操作规程；
3. 检验所用的仪器或设备的型号和编号；
4. 检验所用的试液和培养基的配制批号、对照品或标准品的来源和批号；
5. 检验所用动物的相关信息；
6. 检验过程，包括对照品溶液的配制、各项具体的检验操作、必要的环境温湿度；
7. 检验结果，包括观察情况、计算和图谱或曲线图，以及依据的检验报告编号；
8. 检验日期；
9. 检验人员的签名和日期；
10. 检验、计算复核人员的签名和日期。
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