The proper sterilisation of medical devices, surgical instruments, supplies and equipment utilised in direct patient care and surgery, together with the preparation of medicinal products that are required to be filled aseptically, is a critical aspect of the modern health care delivery system and ...
Previously, KGMP audit application required the manufacturer to submit basic information such as the name and location of the manufacturing plant. However, under the revised requirements, the application should also include additional information such as the correlation of th...
reflecting reducedrequirementsforthe replacement of furniture and office equipment resulting from extending the lifespan [...] daccess-ods.un.org daccess-ods.un.org [...] 时间的协同努力;工作人员差旅项下的 121 200 美元,其主要原因是增加对视频 会议的使用、尽可能合并差旅和(或)减少差旅时间;订约...
Pass-through hatches should be designed to protect the higher grade environment, for example by effective flushing with an active filtered air supply.The movement of material or equipment from lower grade or unclassified area to higher grade clean areas should be subject to cleaning and disinfection ...
Generally speaking, when one thinks of cleaning validation, the first thing that comes to mind is “prevention of cross-contamination”, which obviously applies only when equipment is used for manufacturing more than one product. So why is cleaning validation talked about with regard to dedicated ...
1.1. This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (MIA) holder which imports medicinal products (human and veterinary) from outside the EU/EEA. The guidancein the main chapters and annexes o...
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Equipment Validation Guideline This SOP describes the approach and methods for equipment qualification at a GMP manufacturing site. This validation guideline aims to provide a clear statement of the scope, validation approach, and testing requirements for equipment validation. Facility and Utility Validati...
The critical zone of the RABS or open isolator used for aseptic processes should meet Grade A requirements with unidirectional airflow. In closed isolator systems where airflow may not be unidirectional, it should provide...
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use...