PICGMP附件8原.docVIP

ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS 附则 8 原料及包装材料的抽样 PRINCIPLE 原则 Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on non-representative samples. Correct sampling is thus an essential part of a system of Quality Assurance. 抽样是一个重要的作业。抽样系指抽取一个批次中的一小部分。整个批次之有效结论不能以在无代表性之样品上所从事的试验为基础。因此，正确的抽样是质量保证系统的一个必要的部分。 Note: Sampling is dealt with in Chapter 6 of the Guide to GMP, items 6.11 to 6.14. These supplementary guidelines give additional guidance on the sampli