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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:761094Orig1s000 PRODUCT QUALITY REVIEW(S)Center for Drug Evaluation and Research Office of Pharmaceutical Quality Office of Biotechnology

How to fill out container-closure

How to fill out container-closure

1. To fill out a container-closure, follow these steps:
2. Remove any existing closure, such as a lid or cap, from the container.
3. Clean the container and closure thoroughly to remove any residue or contaminants.
4. Check the container and closure for any damage or defects. Replace them if necessary.
5. Place the closure on top of the container, ensuring it fits securely.
6. Apply pressure or twist the closure to seal it onto the container tightly.
7. Inspect the seal to ensure it is properly closed and there are no leaks or gaps.
8. Label the container with appropriate information, such as the contents, date, and any other relevant details.
9. Store the filled container in a suitable location according to the specific requirements of the contents.
10. Repeat the process for each container that needs to be filled out.
11. Properly dispose of any leftover or unused closures.

Who needs container-closure?

1. Container-closures are needed by various industries and individuals who require a secure and safe method of packaging or sealing containers. Some examples include:
2. - Pharmaceutical companies: They use container-closures to ensure the integrity and sterility of medications.
3. - Food and beverage manufacturers: They use container-closures to prevent contamination and maintain the freshness of their products.
4. - Chemical and hazardous material handlers: They use container-closures to prevent leaks, spills, and exposure to potentially harmful substances.
5. - Laboratory and research facilities: They use container-closures to store and transport samples or specimens while maintaining their integrity.
6. - Individuals for home storage or transportation: They use container-closures to store various items such as food, liquids, personal care products, etc.

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What is container-closure?

Container-closure is the process of sealing a container to protect its contents from air, light, moisture, or other contaminants.

Who is required to file container-closure?

Manufacturers and distributors of products that require sealed containers are required to file container-closure.

How to fill out container-closure?

Container-closure forms can typically be filled out online or submitted electronically through a regulatory agency's website.

What is the purpose of container-closure?

The purpose of container-closure is to ensure the safety and integrity of the product inside the container by preventing contamination or tampering.

What information must be reported on container-closure?

Information such as the type of container used, the sealing method, and any additional security measures must be reported on container-closure forms.