Supplement manufacturing facilities following Good Manufacturing Practices are expected to set, meet and document specifications for all incoming and outgoing materials. Failure to do so could lead to a regulatory action such as an injunction. GMP Specifications are needed for:
- Components
- In-process production
- Labels and Packaging
- Finished Batch of the Dietary Supplement
- Product received from a supplier
- Packaging and labeling for the finished Dietary Supplement.
Specifications ensure the identity, purity, strength and composition of the final product as well as reduce the chances of the final product becoming adulterated. In order to meet specifications, each component must be tested. The method, results and acceptable range of results need to be recorded. Other requirements for specifications include safety, handling and sampling instructions.
It is common to have different versions of specifications for the same material. Each version must be numbered and include a reason for its creation. For example, there may be a different set of specifications for a foreign market.
How InstantGMP Helps
InstantGMP MES includes an automated method for handling specifications. Since the software reinforces Good Manufacturing Practices, a specifications approval process is part of the workflow. Watch this video for information on setting specifications using InstantGMP: