Correcting Label Mishaps: SOP for Handling Bottles with Improper Labels in Pharmaceutical Settings

• by Radhika Mohan B
• 18 Sep 2009
• Coaching

Labeling errors on filled bottles can have serious consequences in pharmaceutical manufacturing. This article presents a Standard Operating Procedure (SOP) designed to guide the proper handling of bottles labeled with inaccuracies. Explore detailed steps for identification, segregation, and corrective measures to ensure compliance, product integrity, and adherence to regulatory standards in pharmaceutical labeling processes.

Handling filled bottles labeled with improper labels is a critical process to ensure product quality and compliance with regulatory requirements. An SOP for this procedure helps ensure that such bottles are identified, properly corrected, and documented to maintain product integrity and traceability. Below is an outline for an SOP for handling filled bottles with improper labels:

Title: SOP for Handling Bottles with Improper Labels

Objective: To establish a standardized procedure for identifying, correcting, and documenting bottles filled with improper labels to ensure product quality and compliance.

Scope: This SOP applies to all personnel involved in the handling of bottles with improper labels in a pharmaceutical or manufacturing setting.

Responsibility:

• Quality Assurance: Responsible for reviewing and approving this SOP.
• Production Supervisor: Responsible for overseeing the correction process.
• Operators: Responsible for identifying and documenting bottles with improper labels and implementing corrective actions.

Equipment and Materials:

1. Bottles with improper labels
2. Correct labels
3. Scissors or label removal tools
4. Adhesive or labeling equipment (if applicable)
5. Quality control documentation
6. Replacement labels (if required)
7. Sealable plastic bags or containers
8. Labeling correction log or documentation
9. Personal protective equipment (PPE), if necessary

Procedure:

1. Identification:

   a. During the quality control inspection or packaging process, if bottles with improper labels are identified, immediately stop the process.

   b. Record the details of the bottles, including batch numbers, quantities, and the nature of the labeling issue.

2. Segregation:

   a. Segregate the bottles with improper labels from the correctly labeled ones.

   b. Place the bottles with improper labels in a designated area for correction.

3. Label Removal:

   a. Carefully remove the improper labels from the bottles using scissors or label removal tools.

   b. Ensure that no adhesive residue or remnants of the improper labels remain on the bottles.

4. Label Replacement:

   a. Apply the correct labels to the bottles following the approved labeling procedure.

   b. Ensure that the correct labels are accurately applied, properly aligned, and securely adhered.

5. Quality Control Check:

   a. Conduct a quality control check on the bottles with the replaced labels to ensure that the labeling issue has been resolved.

   b. Verify that all bottles now have the correct labels and meet quality standards.

6. Documentation:

   a. Record the details of the labeling correction process, including the date, batch numbers, quantities, and the names of personnel involved.

   b. Maintain records of the bottles with improper labels and the corrective actions taken.

7. Reverification:

   a. After the labeling correction, reverify the bottles to ensure that they meet all quality and compliance requirements.

8. Release for Distribution:

   a. If bottles with improper labels are successfully corrected and meet all quality standards, they can be released for distribution or further processing.

9. Non-Conforming Material Handling (if applicable):

   a. If bottles cannot be corrected or if they fail quality control checks, follow the established procedure for handling non-conforming materials, which may include disposal or rework.

Training and Records:

1. Ensure that all personnel involved in handling bottles with improper labels are adequately trained and have access to this SOP.

2. Maintain records of training and any deviations from this procedure.

References:

List any relevant documents, such as quality control standards, labeling procedures, or other SOPs that apply to this process.

Revision History:

Document any revisions made to this SOP, including dates and descriptions of changes.

This SOP for Handling Bottles with Improper Labels provides a systematic and standardized approach to address labeling issues, ensuring product quality and regulatory compliance. Regular training and periodic review of this SOP are essential to maintain its effectiveness and relevance.