The Product Labeling Procedure establishes uniform guidelines for the content preparation of labels and control of labeling in compliance with company policy directives.

Products manufactured and distributed by the company must be properly labeled according to all applicable domestic and international laws and regulations. Labeling must included adequate information to describe the product, operating instructions, hazard warnings, and any other information to avoid accidental misleading or incomplete identification.

The Product Labeling Procedure applies to all labels and labeling (see definitions below) for all products manufactured and distributed by the company. Promotional material and operation manuals are covered by other specific SOP statements. (6 pages, 1,191 words)

Product Labeling Definitions:

Label – Any display of written, printed, or graphic matter upon the immediate container of the product.

Labeling – Includes labels above and other written, printed, or graphic matter on product containers, wrappings, or accompanying the product such as tags, pamphlets, direction sheets, operation manuals, promotional material, or package inserts.

Promotional Material – Advertisements, direct mail pieces, brochures, selling aids, films, or similar materials or media whereby claims concerning safety, efficacy, reliability, or other product attributes may be made or inferred to the customer.

Misbranding – A product is misbranded if:

Its labeling is false or misleading;
Its packaging does not bear a label containing the name and place of business of the manufacturer or distributor and an accurate statement of the quantity of contents;
Words, statements, or other required information are not prominent on The labeling or are not stated clearly;
It does not contain adequate directions for use including warnings against use in certain conditions;
The product’s established name, if it has one, or common or usual name is not printed prominently in type at least half as large as used for any proprietary name;
A medical device is commercially distributed without FDA concurrence on a 510(k) pre-market notification submission.

Product Labeling Procedure Activities

Labeling Preparation
Labeling Approval and Implementation
Label Control

Product Labeling Procedure References

Statutory and Regulatory Requirements-Statutes and regulations governing labeling of products vary by country, state, municipality, and the nature of the company’s products. The Company must be aware of and must be in compliance with applicable law in all locations where it conducts business. Examples of labeling regulations include:

• U.S. Code of Federal Regulations – Food Labeling (21 CFR 101); and
• Consumer Packaging and Labeling Regulations, Canada (CRC, c. 417).