What standards do self-adhesive coated paper need to meet when it is used for drug labels?

When self-adhesive coated paper is used for drug labeling, it needs to meet a series of strict standards to ensure the accurate communication of drug information, the safe use of patients, and the durability and compliance of drug labeling. Here are some of the main standard requirements:

First, material standards

1. Material selection:

Pharmaceutical labels often use mirror coated paper, coated paper and matte paper, and some high-end products may also use aluminum foil or gold foil paper. These materials need to have good printing effect and durability.

The self-adhesive backing paper is tightly fitted to the surface material to ensure that the label does not fall off during the pasting process.

2. Physical properties:

The paper needs to have a certain thickness and stiffness to adapt to different labeling environments and pharmaceutical packaging shapes.

It is necessary to have good tensile resistance, friction resistance and chemical corrosion resistance to meet various challenges in the process of transportation and storage.

Second, printing standards

1. Printing quality:

Printing color should be accurate, bright, full, no obvious color difference.

The text and pattern should be clear and easy to distinguish, with uniform ink, no broken lines, no leakage, etc.

The printed content must comply with the drug instructions and label management regulations, including the drug name, specifications, usage and dosage, production date, expiration date and other key information.

2. Printing process:

Letterpress printing and flexographic printing are often used to ensure the printing effect and efficiency.

The printing process needs to use environmentally friendly ink, which meets the requirements of relevant national regulations.

Third, content standards

1. Information accuracy:

All information on the label must be accurate and consistent with the drug instructions.

Text and logos that imply efficacy, misleading use and inappropriate advertising of the product shall not be printed.

2. Warnings and precautions:

The drug label should contain the necessary warnings and precautions to guide patients to use the drug correctly.

For drugs under special management (such as narcotic drugs, psychotropic drugs, etc.), the label must be printed with a sign of compliance.

Fourth, compliance standards

1. Regulatory compliance:

Drug labels must comply with the requirements of relevant regulations such as the "Provisions on Drug Instructions and Label Management" issued by the State Food and Drug Administration.

Everything on the label needs to be approved by the State Food and Drug Administration.

2. Language specification:

The drug label shall use the standardized Chinese characters published by the State Language Commission, and if other characters are added for comparison, the Chinese characters shall prevail.

The font, size and color must meet the specified requirements to ensure the salience and legibility of the information.

Fifth, other standards

1. Weather resistance:

Drug labels must have good weather resistance and can maintain stable performance under environmental conditions such as sunlight, ultraviolet light, humidity, high temperature and low temperature.

2. Adhesion:

Self-adhesive labels need to have good adhesion, can be firmly adhered to the drug packaging, not easy to fall off.

In summary, when self-adhesive coated paper is used for drug labeling, it needs to meet the standards of material, printing, content, compliance and other aspects. The formulation and implementation of these standards are of great significance to ensure the safety of drug use for patients and maintain market order.