RE:RE:RE:RE:RE:RE:RE:Start of new week recapenemenemynemoron,
when a company has a production capability of producing 40 litre batches and then ramps up to a 200 litre batch, that would be considered a major change. that requires fda approval.
A major change is a change that has a substantial potential to have an adverse effect on the
identity, strength, quality, purity, or potency of a drug product as these factors may relate to the
safety or effectiveness of the drug product. A major change requires the submission of a
supplement and approval by FDA prior to distribution of the drug product made using the change.
dd holds up better than fud