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WHO原料药的预认证。由于高质量的原料药是生产高质量药品的关键，PQP开始尝试对原料药进行认证。此公开的预认证原料药目录将为联合国机构，各国药品管理当局及其他各界提供符合WHO标准的原料药信息。预认证原料药目录为药品生产企业提供了质量保证的原料药生产企业的信息。获得预认证的原料药企业可以提供给药品制剂生产企业符合WHO及国际标准... 阅2296 转20 评0 公众公开 14-05-05 11:23 |
WHO publishes Draft on Revised Process Validation Guideline: Validation Life-Cycle Required.Phase I Process design Phase II Qualification and process verification Phase IIA Qualification Phase IIB "Continuous process performance verification" Phase III Continued process verification.How should a combination ... 阅198 转4 评0 公众公开 13-05-23 09:17 |
Types of Certificates1.3 Types of Certificates.A certificate issued by either the manufacturer or by the competent authority of an exporting country confirming that the quality of a specific batch of the product conforms to specifications approved at the time of issuance of product license by the competent authority i... 阅81 转2 评0 公众公开 13-04-24 11:42 |
WHO认证“希望更多的中国制药公司参与世界卫生组织(WHO)的预认证，我们正在为中国企业提供相关的技术支持。”日前，在中国医药国际交流中心、WHO、欧洲药品质量管理局(EDQM)联合主办的原料药质量研讨会上，几位WHO、EDQM的官员都不约而同地表示。而无论是获得WHO-PQ认证还是EDQM的认证，都意味着获得了进入国际医药市场的通行证，企业突破发达... 阅3660 转12 评0 公众公开 12-11-22 11:42 |
WHO issues Update of Pharmaceutical Water Guideline.It is also new that the pharmaceutical manufacturer is in responsible of ensuring that the feed water has drinking water quality.In the chapter inspection of a water system it was further added that an on-site inspection of the treatment as well as of the distributio... 阅92 转0 评0 公众公开 12-11-01 10:38 |
WHO publishes revised Draft Guideline on Quality Risk Management。3.1 Training and education3.2 Responsibilities3.3 QRM application during product development3.4 QRM application during validation and qualification3.5 QRM application during commercial manufacturing3.5.1 QRM integration with key quality system elements3... 阅77 转0 评0 公众公开 12-10-24 09:20 |
WHO issues revised version of HVAC ...WHO issues revised version of HVAC Guide.The practical Guide has been extended by the following chapters:4.6 Displacement concept (low pressure differential, high airflow) 4.7 Pressure differential concept (high pressure differential, low airflow) 4.8 Physical barrier concept 7.2 ... 阅31 转1 评0 公众公开 11-11-28 13:02 |
New WHO guidance for Storage and Transportati... 阅96 转1 评0 公众公开 11-08-29 11:43 |
