The description of the starting material shall include the manufacturing strategy, purification/inactivation procedures with their validation and all in-process control procedures designed to ensure the quality, safety and batch to batch consistency of the finished product.
Áireofar sa chur síos ar an ábhar tosaigh an straitéis mhonaraíochta, nósanna imeachta íonghlanta/díghníomhaithe agus a mbailíochtú agus gach nós imeachta le linn próisis chun cáilíocht, sábháilteacht agus aonchineálacht ó bhaisc go baisc den táirge críochnaithe a áirithiú.