cGMP for Clinical Phase Virtual Manufacturers

See my first article on this topic at https://www.outsourcedpharma.com/doc/does-a-phase-virtual-biopharma-company-need-a-cgmp-quality-system-0001

What is the scope the cGMP activities required for an IND sponsor who outsources the manufacturing and testing of their clinical supplies? Scope your system based not on opinion or previous experiences but on law, regulations, and guidance. See also FDA Ref cGMP for IND sponsor

IT System Validation

In June 2017, FDA released a Draft Q&A/Guidance on Part 11 with limited scope (investigational phase for clinical and PDMA records).  Reading between the lines, this articulates explicitly what validation experts have been saying for years in terms of taking a risk-based approach versus one-size-fits-all when validating Commercial Off the Shelf (COTS) systems.

Digital Signatures

If your staff is geographically dispersed, signs documents and sends via email or uploads to your shared storage system via the Internet, then you have what FDA terms an “Open System”. For Open Systems, you are required to have special controls including (per 21CFR Part 11.30) “digital signature standards to ensure…record authenticity, integrity, and confidentiality”. So, if your staff and contractors communicate via internal-to-your-organization email and document management systems, you can use electronic signatures; otherwise, you need Digital Signatures.  Download Digital Signatures Overview.pdf for more information.