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RegisterType II Variation [Regulatives / Guidelines]
Dear Dr Dan,
Thank you for your response.
Reviewing the available literature I came across this presentation 3-2 Biobatch considerations for quality.
According the information on slide 4 "A biobatch of < 100,000 units may be accepted, but then no scale-up is allowed. This should be clearly indicated in reports for the product, as it affects allowable variations."
This information was the reason for the concern raised.
Could you please indicate a guideline/regulation which states that the scale up is possible even if the biobatch is < 100,000 units.
Kind regards,
Elena
Thank you for your response.
Reviewing the available literature I came across this presentation 3-2 Biobatch considerations for quality.
According the information on slide 4 "A biobatch of < 100,000 units may be accepted, but then no scale-up is allowed. This should be clearly indicated in reports for the product, as it affects allowable variations."
This information was the reason for the concern raised.
Could you please indicate a guideline/regulation which states that the scale up is possible even if the biobatch is < 100,000 units.
Kind regards,
Elena
Complete thread:
- biobatch size and scale up Elena 2013-09-17 10:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Type II Variation Helmut 2013-09-17 16:36
- Type II Variation Elena 2013-09-18 08:42
- Type II Variation Dr_Dan 2013-09-18 10:01
- Type II Variation Ohlbe 2013-09-18 12:41
- Type II VariationElena 2013-09-18 12:55
- Type II Variation Dr_Dan 2013-09-18 10:01
- Type II Variation Elena 2013-09-18 08:42
- Type II Variation Helmut 2013-09-17 16:36
Ing. Helmut Schütz