Managing inventory in a way that is compliant with GMP can be challenging. Regulatory measures specific to handling inventory are included in the Dietary Supplement Health and Education Act (DSHEA). The regulations apply to all incoming materials, work-in-progress materials, and all completed products.
All supplement manufacturers must obtain raw materials from trusted vendors. This means verifying a suppliers Certificate of Analysis. A Certificate of Analysis should include:
- A description of the tests done on the material.
- The actual results.
The work is not done after simply verifying the certificate though. You should also document how you qualified the vendor and periodically verify their Certificate of Analyses throughout the relationship. All documentation must be reviewed by quality personnel.
Establishing Material Specifications
For dietary supplements, specifications are required for components used in manufacturing, any step in the process where control is necessary to ensure quality, labels and packaging and, of course, the finished product. If specifications are not met at each step, the product will be rejected by quality and you will need to start over.
How InstantGMP Helps
InstantGMP software provides an automated method for creating and keeping track of material specifications. With GMP workflows built it, specifications are required for materials before they can be used in a batch. Watch this video for more information on how InstantGMP manages suppliers and materials: