1357 A reduced frequency in of If three consecutive process simulations infrequent production may be need to be performed before every justified. Thus, if the interval batch, then this would result in more between the production of two process simulations and therefore does batches is more than six months the not make sense (i.e. 1 batch per year process simulation test can be done would results in 3 process simulations, just before the manufacturing of the whereas in normal frequency, only 2 second batch (three consecutive runs process simulations would need to be should be performed) performed per year, i.e. 1/6 months (excluding the initial validation). Propose to either remove this sentence or provide more explanation 1461 in case of very small production Please define small production’; Is … ‘very this lots/year, units/lot or otherwise defined?
1357 A reduced frequency in of infrequent production may be justified. Thus, if the interval between the production of two batches is more than six months the process simulation test can be done just before the manufacturing of the second batch (three consecutive runs should be performed) If three consecutive process simulations need to be performed before every batch, then this would result in more process simulations and therefore does not make sense (i.e. 1 batch per year would results in 3 process simulations, whereas in normal frequency, only 2 process simulations would need to be performed per year, i.e. 1/6 months (excluding the initial validation). Propose to either remove this sentence or provide more explanation 1461 … in case of very small production Please define ‘very small production’; Is this lots/year, units/lot or otherwise defined?
atmp_wg_nlbe.docx