For ‘classical fermentation’, the text from [ICH Q7, Section 18.14] ‘…this guide covers cell culture/fermentation from the point at which a vial of the cell bank is retrieved for use in manufacturing’ refers to ‘classical fermentation’ and not to the ‘biotechnology fermentation/cell culture’. Although the entire ICH Q7 Guideline does not apply prior to the introduction of cells into the classical fermentation process, as shown in Table 1 of [ICH Q7, Section 1.3], an appropriate level of GMP controls suitable for cell banks should be established.
For ‘biotechnology fermentation/cell culture’ [ICH Q7, Section 18.2] on ‘Cell Bank Maintenance and Record Keeping’ applies specifically to biotechnology fermentation/cell culture because ICH Q7 starts with the maintenance of the working cell bank [ICH Q7, Section 1.3, Table 1]. Although for biotech products the entire ICH Q7 Guideline does not apply prior to the maintenance of the working cell bank, an appropriate level of GMP controls suitable for cell banks should be established. See also [ICH Q5B, ICH Q5D].
