cGMP production practices
Manufacturing is organized around written procedures, trained operators, and documented batch records. Our process language follows the dietary supplement current good manufacturing practice framework in 21 CFR Part 111.
Process control you can review
Quality at Solen Nutra is a set of written practices — not a collection of badge numbers. We describe how materials are checked, how batches are made, and how lots are released.
How we approach quality
Dietary supplement production depends on consistent materials, controlled process steps, and a clear release decision. The points below describe the practices used at our City of Industry facility. They are written as operating practices rather than as claims of a numbered certificate.
Raw material identity testing
Incoming ingredients are identified before they are released to production. Identity testing is performed in-house, and materials that do not meet the agreed specification are not used.
In-process controls
Defined checkpoints during blending, compression, encapsulation, and fill help keep each lot within the process limits set in the batch record.
Finished product testing
Released lots are tested against the product specification. Typical checks include appearance, weight or fill, and assay or input confirmation as agreed for the project.
In-house laboratory
The on-site lab supports identity, quality, and microbiological testing used in routine release. Third-party laboratories are used when a method or workload calls for it.
Documentation and release
A lot is released only after the quality unit reviews the batch record and test results. A certificate of analysis is issued with the shipment.
What a typical testing plan covers
The exact plan is set with each formula. Most projects include some combination of the following.
- Identity of incoming ingredients
- Purity and quality checks appropriate to the material
- Microbiological limits as specified for the product
- Finished-product appearance, weight or fill, and potency or input confirmation
- Stability study support when a shelf-life claim needs data
21 CFR Part 111, in practice
Part 111 sets out current good manufacturing practice for dietary supplements in the United States. In our operation that means written procedures, material controls, master manufacturing records, production records, quality-unit review, and a hold-and-release decision before a lot leaves the facility.
If you need a quality questionnaire or a process overview for a vendor packet, include that request in your inquiry.
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