Too many virtual biotech companies are working with disjoined systems trying to manage a variety…
Next Tuesday, InstantGMP and EAS Consulting Group present SOPs: The Foundation of a Quality System. There’s still time to sign up! We will be sharing helpful information on SOPs including the outline of an SOP and examples of how SOPs are applied throughout the manufacturing process.
Webinar Preview: Implementation
While the overall purpose of implementing Standard Operating Procedures using Good Manufacturing Practices is fairly straightforward, implementation another beast entirely.
FDA regulations are written in general terms so the first step in establishing policies and SOPs involves interpreting regulations in a way that applies to your specific manufacturing process. Procedures should outline the different parts of the manufacturing process including:
- Facility operations
- Material controls
The quality team will often work with regulatory consultants and individuals familiar with the manufacturing processes to write policies and the subsequent SOPs. Upon successful testing of the procedures, the operations team will be trained accordingly. Should revisions need to be made in the future, they will be reviewed and documented by the quality team.
By following well-written SOPs, you create consistent, high-quality products that consumers trust.
Want to learn more? We hope you’ll join us Tuesday, February 24th!