SOCIAL QUESTIONS|health|pharmaceutical industry
- comhsheasmhacht ó bhaisc go baisc Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs 'Dearbhóidh monaróir na substainte gníomhaí i scríbhinn don iarratasóir go n-áiritheoidh sé comhsheasmhacht ó bhaisc go baisc agus nach n-athróidh sé an modh monaraíochta ná na sonraíochtaí gan é sin a chur in iúl don iarratasóir.' Tagairt "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
- batch-to-batch consistency
- en
- Sainmhíniú fact that different batches produced by a manufacturing process share the same quality Tagairt "COM-Terminology Coordination, based on: - EMA. COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS. NOTE FOR GUIDANCE ON PROCESS VALIDATION (18.1.2021). CPMP/QWP/848/96 EMEA/CVMP/598/99- EMA. Committee for Medicinal Products for Human Use (CHMP). 'Additional guidance on documents relating to an active substance master file' (18.1.2021). EMA/CHMP/CVMP/QWP/549010/201"
- Nóta In the pharmaceutical industry, at least three consecutive batches are usually validated, but the number of batches to be taken in order to validate a process is not regulated.