definiens: or means the document, proposed by AMT and subsequently approved in writing by Institut Pasteur . The AMT proposed document, or revisions thereto, will be approved by signature and dating by at least one representative of AMT 's quality unit and will be prepared in accordance with Section 6.41 of Volume 4 of the " EU Guidelines to Good Manufacturing Practice, Medicina l Products for Human and Veterinary Use, Part n, Basic Requirements for Active Substances used as Starting Materials ", and which specifies : 6 ActivcUS I j 7431250v.1 ( a ) The name of the Product being manufactur ed and an identifying document reference code ; and ( b ) A complete list of raw materials and intermediates designated by names or codes sufficientl y specific to identify any special quality characteri stics ; and ( c ) A complete set ofraw material specification s listing specific methods used for confirming compliance with specification ; and ( d ) A complete list of resin, filtration membranes, filter cartridges etc ., designated by names or codes sufficiently specific to identify manufacturer, type and/or model, as appropriate ; and ( e ) An accurate statement of the quantity or ratio of each raw material or intermediate to be used, including the unit of measure . Where the quantity is not fixed, the calculation for each batch size or rate of production should be included . Variation s to quantities will be included where justified ; and ( f ) The production location(s ) and production equipment to be used, including the ; ( i ) The unique identification number of the production location(s ) ( for example -suite / room numbers, laminar flow cabinets etc . ) ; and ( ii ) The unique identification number of each production piece of equipment to be used ; and ( iii ) Confirmation of the production equipment 's approved calibration status ; and ( g ) Detailed production instructions, including the : ( i ) Sequences to be followed ; and ( ii ) Initial process set - point and acceptable operating ranges of all processing parameters to be used ; and ( iii ) Sampling instructions for in - process control samples, in - process control methods with their acceptance criteria where appropriate ; and ( iv ) Time limits for completion of individual processing steps, hold times andlor the total process time limit, where appropriate ; and ( h ) Detailed finished Product Release Specification testing instructions, including the : 7 ActivcUS 117431250v.1 ( i ) Sampling instructions and Release Testing Specifications indicating the release acceptance criteria ; and ( ii ) Release Testing methods ; and ( i ) Where appropriate, special notations and precautions to be followed, or cross references to these ; and G ) Instructions for the storage of the Product and isolated intermediate products ( for example -Inclusion Bodies ) to assure their suitability for use, including the labelling and packaging materials and special storage conditions with time limits and hold times, where appropriate