Technical / White Paper

Supply Chain Transparency in the New Virtual World

Format: PDF file | Document type: Technical / White Paper

Supply Chain Transparency in the New Virtual World

Related categories: Vitamins & premixes

Historically, the relationship between Brand Owner and the Contract Manufacturer (CMO) involved an on-site audit of the manufacturing site. While the practical realities of Covid-19 have put a damper on that, the obligations under 21CFR Part 111 of both the Brand Owner and CMO never changed. While the FDA may have suspended on-site audits, they were still reviewing websites, literature, and issuing warning letters for non-conformities. This whitepaper from Gemini Pharmaceuticals will outline the approach the Brand Owner can take to ensure compliance with the regulations in these troubled times.

Latest content from Gemini Pharmaceuticals

Three signs you need a new contract manufacturer

Content provided by Gemini Pharmaceuticals

Three signs you need a new contract manufacturer

How does a dietary supplement brand owner know it’s time to make a change in their production partnership? Sometimes the signs are fairly clear. For example, finding the company in the middle of a product recall due to a serious manufacturing error is...

Related resources from Gemini Pharmaceuticals

Show more

Supplier info centre