One of the key elements of quality control in pharmaceutical manufacturing is cGMP compliance. As your product moves closer to market, cGMP requirements change and become more stringent. Dalton Pharma Services has created a whitepaper to download, FDA Guidelines for GMP of API.
Featured in this whitepaper which you can download here:
- API and GMP overview
- FDA API regulations including: laboratory controls, equipment, facilities, personnel and more
- FDA guidelines including: documentation, distribution, packaging, validation, complaints, recalls and more
- API guidelines for clinical trials
- Dalton says it can support cGMP API development at any stage, by reducing costs and timelines. It has expertise in cGMP compliance and is FDA-inspected, Health Canada-approved, and MRA with EFA.