Complete and perfect qualification master plan and validation master plan 完成和完善確認主計劃和驗證主計劃。
In case of large projects , it may be necessary to create separate validation master plans 如果項目龐大,則需要制定分開的驗證主計劃。
Prior to full - scale operation , the validation master plan should be finalized . most often , this should contain three sections : strategy , protocols , and evaluation 全面運轉之前,應完成鑒定總計劃。通常應該包含三部分:策略、協(xié)議和評估。
For establishing validation policy and procedures for k - company non - sterile dosage forms , a comprehensive validation master plan has been written as attached 為了建立k公司非無菌制劑的驗證方針和規(guī)程,需要全面的驗證主計劃,如附件所示。
All validation activities should be planned . the key elements of a validation program should be clearly defined and documented in a validation master plan ( vmp ) or equivalent documents 所有驗證活動都要進行規(guī)劃。驗證計劃的關鍵組成部分應該明確定義并在驗證主計劃( vmp )或類似文件中寫明。
The Validation Master Plan also referenced as "VMP" is one of the key documents in the GMP (Good manufacturing practice) regulated pharmaceutical industry. Even though it is not mandatory the Food and Drug Administration inspectors will ask you for it when they inspect your facility.