definiens: means the then - current good manufacturin g practices required by : ( a ) the provisions of 21 C.F.R., parts 210 and 211 and all applicable rules, regulations, orders and guidances ( as the same may from time to time be amended ) ; ( b ) ICH, Guidance for Industry Q7a Good Manufacturing Practice Guidance for Activ e Pharmaceutical Ingredients ( as the same may from ti me to time be amended ) ; ( c ) the provisions of Chapt er II of EC Commission Directive 91\356\EEC together with th e Guide to Good Manufacturing Practice published by the EC Commission in 1992 ( ISBN 92 - 826 - 3180 - X ) ( as the same may from time to time be amended ) ; and ( d ) any other applicable Laws, guidelines, regulati ons and industry standards, that apply to any manuf acturing or processing activities hereunder, or the facilities in which any such activities are performed