原料管制作業說明，是由製造業者提出該廠之動物原料控管及處理程序，可充分顯示原料未受病原污染，以及製程中病毒去活化、滅菌等程序之說明。動物原料來源證明[certificate of origin]，是由製造業者之動物原料供應商提出，應顯示該畜場非屬農委會公告之疫區範圍。前述文件要求及相關驗證建議可參考以下標準：
1. ISO 22442-1「Medical devices utilizing animal tissues and their derivatives
—Part 1: Application of risk management」
2. ISO 22442-2「Medical devices utilizing animal tissues and their derivatives
— Part 2: Controls on sourcing, collection and handling」
3. ISO 22442-3「Medical devices utilizing animal tissues and their derivatives
— Part 3: Validation of the elimination and/or inactivation of viruses and
transmissible spongiform encephalopathy (TSE) agents」。