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To provide written instructions for creating and revising finished product and label specifications.
Quality Control is responsible for the creation and revision of finished product and label specifications. Only relevant for internal manufacturing of dietary supplements - however, SOP can be used to validate partner manufactuerers
Use Form F-005 – Finished Product and Label Specifications as a template.Fill in the product name. Fill in the specification revision. For new specifications, the specification revision will always be assigned as “01”. Subsequent revisions will follow as “02”, “03”, “04”, and so on. Fill in the physical parameter method/instrument sections, along with acceptance criteria sections. Physical parameters and acceptance criteria will be primarily determined by the purchasing specifications. Visual and physical counting methods will be acceptable.Fill in the analytic parameter method/instrument sections, along with acceptance criteria sections. Analytical parameters will include those analytes that qualified laboratories have methods for, and laboratory testing abilities will determine whether or not the testing methods will be quantitative or qualitative.Acceptance criteria for quantitative methods will generally be set at not less than 95% of label claims to allow for testing variability.Acceptance criteria for qualitative methods will be set as “present”. Fill in the “Per:” amount at the top of the acceptance criteria column in the analytical section. The “Per:” amount will be equal to the Serving Size of the dietary supplement. Fill in the microbial parameter method/instrument sections, along with acceptance criteria sections. Microbial parameters will generally be set with respect to USP’s recommendations at . Fill in the heavy metals parameter method/instrument sections, along with acceptance criteria sections. The acceptance criteria sections are pre-filled with California Proposition 65 limits, but can be changed on a product-by-product basis if needed.Methods used to evaluate heavy metal parameters will be determined by qualified laboratories. Under the label specification section, insert an image of the current approved revision of the label for the product. In the history of revision section, revision will always begin at 01, and the changes section should indicate that the specifications are new. The Quality Control person creating the specifications will mark their initials in the revised by section. Quality Control will review and approve the specifications, along with a signature and date.Fill in the approved date section at the top to match that of the Quality Control approval signature.
Increase the specification revision by one whole number (e.g., 01 becomes 02, 02 becomes 03, and so on). Update any portion(s) of the finished product and label specifications document as needed. In the history of revision section, again increase the revision by one whole number, make note of all changes made, mark initials in the Revised by section, and Quality Control must provide an approval signature and date to make the revisions effective. Change the approved date at the top to match that of the newest Quality Control approval signature.
PURPOSE
RESPONSIBILITY
REFERENCES
F-005 - Finished Product and Label Specificactions.docx
31.7 KB
PROCEDURES
Creating a Finished Product Specification
Revising a Finished Product Specification
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