Case Study: Ultra Botanica achieves audit-ready GMP manufacturing with InstantGMP

Ultra Botanica turns FDA inspections into 1.5-hour traceability audits with InstantGMP

Ultra Botanica, a botanical drug and dietary supplement innovator, faced the challenge of building a fully compliant GMP manufacturing operation from the ground up to commercialize its breakthrough product. With no off-the-shelf system available for small-scale production, the company turned to InstantGMP to implement its MES and QMS software along with its core GMP SOP and policy library.

By adopting InstantGMP's built-in GMP workflows and batch record system, Ultra Botanica successfully established an in-house manufacturing operation. The results were significant, including passing FDA and third-party audits with ease. Most notably, InstantGMP enabled the company to complete a full product traceability audit for an FDA investigator in approximately 90 minutes, drastically reducing a potentially week-long inspection to just a day and a half.

Ultra Botanica