Labeling and Identification Requirements for Raw Materials as per Schedule M

Schedule M of the Drugs and Cosmetics Rules in India sets forth specific requirements for the labeling and identification of raw materials used in pharmaceutical manufacturing. The purpose of these requirements is to ensure that raw materials are correctly identified, traceable, and used appropriately in the production process. Here are the key requirements for labeling and identification of raw materials under Schedule M:

1. Raw Material Name

Each container of raw material should be clearly labeled with its name or proper identification. The name used should match the official name of the

material as specified in pharmacopeial monographs or other recognized references.

2. Batch or Lot Number

A unique batch or lot number should be assigned to each batch or lot of raw material. This number helps in traceability and facilitates tracking of the material throughout its lifecycle, from receipt to usage in production.

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3. Expiry Date

For materials with limited shelf life, the expiry date should be indicated on the label. This date is based on stability studies and ensures that materials are used before their quality may deteriorate.

4. Storage Conditions

The label should specify the recommended storage conditions for the raw material, such as temperature and humidity requirements. Proper storage conditions help maintain the material’s quality and prevent degradation.

5. Manufacturer’s Name and Address

The label should include the name and address of the manufacturer or supplier of the raw material. This information helps in identifying the source of the material and ensures accountability.

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6. Material Grade or Specification

In cases where different grades or specifications of the same material are available, the label should indicate the specific grade or specification being supplied. This is important to ensure that the correct material is used in production.

7. Hazard Warning and Safety Information (if applicable)

If the raw material poses any health or safety hazards, such as being toxic, flammable, or reactive, appropriate hazard warning symbols, precautionary statements, or safety information should be included on the label.

8. Barcoding (Optional)

Barcoding of raw material containers can be used to facilitate efficient tracking and inventory management. While not mandated by Schedule M, barcoding can enhance process efficiency and accuracy.

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9. Legibility and Durability

The label information should be legible, clear, and durable, ensuring that it remains readable throughout the material’s shelf life. Proper labeling helps prevent mix-ups and potential errors during storage and handling.

Conclusion

Adhering to the labeling and identification requirements specified in Schedule M is essential to ensure proper handling, traceability, and correct use of raw materials in pharmaceutical manufacturing. By providing clear and accurate labels with essential information, pharmaceutical manufacturers can maintain the quality and safety of their products and comply with regulatory standards.