What are approaches to validation specifications or validation acceptance criteria for particle size distributions of granulations?
Responses to this question cautioned against specifications implemented prior to determination of true process variation, i.e., a sufficient number of lots must be manufactured and characterized to determine true process variation. Also, particle size distributions may expectedly change with use of new vendors. Several approaches to specifications were proposed as follows: • Statistical difference in particle size between starting materials and the blended granulation. Average particle size was determined by summation of percentages on screens x screen pore size. • Specifications limiting the amount of course particle size and fine particle size extremes. • Defined percentage ranges for multiple particle size fractions which fully characterize the lot particle size distribution; an example with four particle size ranges was provided. Additional discussion of responses was reported in JVT 11, #4 (August 2005). Discussions in JVT and on the website will be updated as new responses are re
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