1.This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms ...
1.This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product andof the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms an...
2、n type rather than handwritten.Additional sheets should be appended, as necessary, to accommodate remarks and explanations.Certificate of a pharmaceutical productThis certificate conforms to the format recommended by the World Health OrganizationNo. of certificateExporting (certifying country):Impor 3、...
This certificate conforms to the format recommended by the World Health Organization No. of certificate Exporting (certifying country):Importing (requesting country):1. Name and dosage form of the product:1.1. Active ingredient(s)2 and amount(s) per unit dose3:For complete composition including ...
Certificateofapharmaceuticalproduct 1 10 ThiscertificateconformstotheformatrecommendedbytheWorld11 HealthOrganization12 No.ofcertificate13 Exporting(certifyingcountry):14 Importing(requestingcountry):15 1.Nameanddosageformoftheproduct:16 1.1.Activeingredient(s) 2 ...
View Abbott Laboratories's WHO GMP Certification details related to GMP Quality Systems on PharmaCompass.com
A copy of the current GMP certificate (Annex 3) orreference to the EudraGMP database should be included, if available. 1.3在生产厂地进行的其他生产活动 Any other manufacturing activities carried out on the site -如果有的话,对生产厂地内的非药品生产活动进行描述。 description of non-...
A copy of current GMP certificate (Appendix 3) or reference to the EudraGMP database should be included, if available. 列出过去5年的现场GMP检查清单,包括日期和进行检验的药政机构的名 称/国家。如果有,应当提供现行的GMP证书(附件3)或引用欧洲GMP 数据库中的副本。 Any other manufacturing activities ...
近年,在 GMP、GCP 和 GLP 检查中,数据完整性、文件记录管理规范性方面的缺陷数量大大上升。可能的原因大致包括(1)太过依赖人员操作,(2)使用了未进行恰当管理和验证的计算机化系统,以及(3)未充分审核和管理原始数据与记录。 1.3. Quality risk management (...
递交APIMF申请资料,由WHO进行文档评估和 APIMF程序仅用于支持成品药品预认证的评GMP评估。通过预认证的原料药企业会列入 WHO清单,并在WHO网站公布,便于联合国代 估,只有在成品药品生产商递交资料后,APIMF 理商、国际采购机构、国家药品权威机构、成品药 程序才能被启动。WHO从2008年3月开始启用 品生产商及时了解...