PDA清洁验证TR主编对现行FDA以及PIC/s清洁指南修改建议

beiwei5du

附件两篇文章时Destin A. LeBlanc（PDA TR29 cleaning validation主编）对现行的FDA清洁验证指南(1993年）以及PIC/s的清洁检查指南（PIC/s PI 006-03）提到的修改建议。

共计六条，建议修改的指南原文罗列如下：
1、PIC/s PI 006-03 “The analytical methods used to detect residuals or contaminants should be specific for the substance to be assayed….” (Section 7.10.2）

2、FDA cleaning validation guidance “When the cleaning process is used only between batches of the same product (or different lots of the same intermediate in a bulk process) the firm need only meet a criteria of "visibly clean" for the equipment. Such between batch cleaning processes do not require validation.” (Section IV.)

3、FDA cleaning validation guidance “However, unlike product residues, it is expected that no (or for ultra sensitive analytical test methods -very low) detergent levels remain after cleaning.” (Section VI.b.)

4、PIC/s PI 006-03 “For certain allergenic ingredients, penicillins, cephalosporins or potent steroids and cytotoxics, the limit should be below the limit of detection by best available analytical methods. In practice this may mean that dedicated plants are used for these products.” (Section 7.11.3(d))

5、PIC/s PI 006-03 and FDA cleaning validation guidance “The period and when appropriate, conditions of storage of equipment before cleaning and the time between cleaning and equipment reuse, should form part of the validation of cleaning procedures. This is to provide confidence that routine cleaning and storage of equipment does not allow microbial proliferation.” (Section 7.7.2)
“In general, equipment should be stored dry, and under no circumstances should stagnant water be allowed to remain in equipment subsequent to cleaning operations.” (Sections 7.7.3）
（Note that this issue of stagnant water also is present in the FDA Cleaning Validation guidance.）

6、FDA cleaning validation guidance “For example, sanitary type piping without ball valves should be used. When such nonsanitary ball valves are used, as is common in the bulk drug industry, the cleaning process is more difficult.” (Section 1)

其中第二条，个人认为还应该建议将“Such between batch cleaning processes do not require validation”进行修订，不是所有的批间清洁都不需要做验证，验证需要基于风险评估以决定是否开展。

nasser

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胜利者

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预知子

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dasheng1980

谢谢分享

ff78efenn9

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小金库

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