612 Adjacent rooms of different grades According to 1 these are guidance should have a pressure differential of values. Suggestion to add’(guidance 10 15 Pa values)’ in the text, similar to Annex 1 – 614 Negative pressure when infectious Would this then apply to materials that materials are used. are known to be (routinely) infected? For exceptional infections it’s not practicable to invert the pressure cascades. 765 For autologous products, each unit If autologous products are used after should be considered a distinct reconstitution as described in section batch. 16 of this document, then why couldn’t a batch consist of several (frozen) units? 798 A copy of the manufacturing order.. Please define manufacturing order 887 This Section develops… This section describes…? 892 identification code (x3) Error: should be ‘donation 899 identification code’ (x3) 901
612 Adjacent rooms of different grades should have a pressure differential of 10 – 15 Pa According to 1 these are guidance values. Suggestion to add’(guidance values)’ in the text, similar to Annex 1 614 Negative pressure when infectious materials are used. Would this then apply to materials that are known to be (routinely) infected? For exceptional infections it’s not practicable to invert the pressure cascades. 765 For autologous products, each unit should be considered a distinct batch. If autologous products are used after reconstitution as described in section 16 of this document, then why couldn’t a batch consist of several (frozen) units? 798 A copy of the manufacturing order.. Please define manufacturing order 887 This Section develops… This section describes…? 892 899 901 identification code (x3) Error: should be ‘donation identification code’ (x3)
atmp_wg_nlbe.docx