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Elena ☆ Macedonia, 2013-09-17 12:06 (4663 d 06:35 ago) Posting: # 11503 Views: 7,214 |
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Dear all, I would kindly like to ask for your advice. According to the CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** "In case of a production batch smaller than 100,000 units, a full production batch will be required." If the biobatch is < 100,000 units, is scale-up allowed according to EU regulations? Thank you, Best regards, Elena |
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Helmut ★★★   Vienna, Austria, 2013-09-17 18:36 (4663 d 00:05 ago) @ Elena Posting: # 11508 Views: 6,528 |
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Hi Elena, ❝ If the biobatch is < 100,000 units, is scale-up allowed according to EU regulations? Do I get you right – you got the approval with a production batch which is <100,000 units and want to scale up? IMHO, this is a “Major Variation of Type II” as defined in 1234/2008/EC Article 2(3), which […] means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned. If waiving criteria of the GL are not fulfilled, I would say you need another BE study.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Elena ☆ Macedonia, 2013-09-18 10:42 (4662 d 07:59 ago) @ Helmut Posting: # 11512 Views: 6,314 |
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Hi Helmut, Thank you for your reply. This really helps. We are still in developing phase and consider the size of the biobatch. Just to be sure, if the biobatch is < 100,000 units and the scale-up is up to 10 fold, a type II Variation is needed, supported by a Bioequivalence study? Kind regards, Elena |
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Dr_Dan ★★ Germany, 2013-09-18 12:01 (4662 d 06:40 ago) @ Elena Posting: # 11514 Views: 6,336 |
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Dear Elena AFAIK if you conduct the BE study with a production scale batch of less than 100.000 then you will get a marketing authorisation for your product with a production scale of less than 100.000. Afterwards you can scale up up to 10 fold with a variation. The kind of variation (type Ia/b, II) depends on the complexity of the production and scale up process. A new BE must not be mandatory. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Ohlbe ★★★ France, 2013-09-18 14:41 (4662 d 04:00 ago) @ Dr_Dan Posting: # 11517 Views: 6,269 |
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Dear all, ❝ A new BE must not be mandatory. Well... I've heard of some dossiers where the French Agency made it a clear condition when granting a marketing authorisation. Regulators are not too happy with applicants who think a little too obviously that they are stupid  . If you run your BE with a batch of 50,000 tablets and claim this will be your full industrial batch size, then come with a variation to increase the size to 500,000 without a new BE, you can expect some difficulties.— Regards Ohlbe |
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Elena ☆ Macedonia, 2013-09-18 14:55 (4662 d 03:46 ago) @ Dr_Dan Posting: # 11518 Views: 6,340 |
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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 |
Ing. Helmut Schütz