ANNEXE 8 : ECHANTILLONNAGE DES MATIERES PREMIERES
ANNEXE 8 : ECHANTILLONNAGE DES MATIERES PREMIERES ET DES ARTICLES. DE CONDITIONNEMENT. Principe. L'échantillonnage est une opération importante au cours de
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guide to good manufacturing practice for medicinal products annexes
01-Feb-2022 Annex 1 Manufacture of sterile medicinal products. PE 009-16 (Annexes). -8-. 1 February 2022. 41. Changing and washing should follow a ...
Guide bonnes pratiques de fabrication
06-May-2019 ANNEXE 7 FABRICATION DES MÉDICAMENTS À BASE DE. PLANTES. LD.8. ... Bonnes Pratiques de Fabrication (BPF) pour les médicaments.
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Partie A
01-Jun-2017 CHAPITRE 8 : RECLAMATIONS DEFAUTS QUALITE ET RAPPELS DE PRODUITS . ... pas des annexes aux principes des BPF
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Annex 11: Computerised Systems
8. Printouts. 8.1 It should be possible to obtain clear printed copies of electronically stored data. 8.2 For records supporting batch release it should be
Annex 16: Certification by a Qualified Person and Batch Release
12-Oct-2015 Any other relevant legal requirements are taken into account. iv. In the event that a quality defect as referred to in Chapter 8 of EudraLex ...
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Application de la spectroscopie Raman à profondeur sélective aux
D'autres recherches ont suivi dans le cadre de l'Annexe 8 des BPF (PIC/S) avec un spectromètre Raman à profondeur sélective (RapID Agilent). Les résultats.
FR RapID In container testing of raw materials application
Draft Annex 15 - V12 200115 - for PICS and EC adoption
30-Mar-2015 8. 5.17. Where a concurrent validation approach has been adopted ... viii. Proposed in-process controls with acceptance criteria and the ...
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Annex 11: Computerised Systems
11-Jan-2011 8. Printouts. 8.1 It should be possible to obtain clear printed copies of electronically stored data. 8.2 For records supporting batch ...
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Final version sent to EC
12-Oct-2015 8 The importation of active substances used in the manufacture of medicinal products for human use should comply with the requirements of ...
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