Number of Process Validation Batches Before Product Release
Does cGMP regulations require three successful process validation batches before a new active pharm…
Does cGMP regulations require three successful process validation batches before a new active pharm…
How does FDA interpret the regulations (21CFR part 211) regarding the establishment of expiry datin…
Is parametric release an appropriate control strategy for sterile drug products that are not termin…
Skip or Periodic Testing Periodic or skip testing is the performance of specified tests at release …
Technology transfer significantly impacts the pharmaceutical industry in various ways: Innovation A…