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如题:
Question: “Must a firm quantify the amount of residue on equipment surfaces in support of validating the cleaning procedure?”
Answer: “In validating the original cleaning procedure, a firm need not quantify the level of chemical contamination remaining after manufacturing a product and before cleaning during validation exercises. The firm must, however, ensure that they validate the proposed cleaning procedure as for routine use, and not pre-clean or otherwise attempt to make it easier for the procedure being validated to meet its cleaning objectives.”
So, the question is, are these initial steps described above a type of pre-cleaning that is not allowed under this FDA CGMP Note? If the answer is “Yes”, then we are in a lot of trouble. However, I think what the FDA is getting at is doing some kind of pre-cleaning in the validation protocols that is not ordinarily done. I think that as long as the pre-cleaning is part of the written procedure, as long as it is adequately specified/defined, and as long as it is challenged in the validation protocol, pre-cleaning should be acceptable.(只要预清洗满足一下基本要求:作为书面文件被正式规定,或者足够的说明和定义,或者在清洁验证方案中被挑战,预清洁是可以被接受的。)
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