Standard Operating Procedure for Lotion Labeling

1) Purpose

The purpose of this SOP is to outline the standardized procedure for the labeling of lotions to ensure proper identification, traceability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the labeling process of lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Labeling Operators:

• Perform the labeling process as per the SOP.
• Ensure labels are correct and free from defects.

Quality Control Personnel:

• Inspect and verify the accuracy and quality of the labels.
• Ensure compliance with labeling specifications and standards.

Labeling Supervisors:

• Oversee the labeling process to ensure adherence to the SOP and address any issues.

4) Procedure

4.1 Pre-Operational Checks:

• Ensure the labeling area is clean and sanitized.
• Verify the availability and correctness of labels, including batch numbers, expiration dates, and other required information.
• Ensure all labeling equipment is clean, calibrated, and in good working condition.

4.2 Labeling Process:

1. Label Verification:
   1. Check that the labels match the product specifications and regulatory requirements.
   2. Ensure that the labels are free from defects such as smudges or misprints.
2. Label Application:
   1. Set up the labeling machine according to the specified settings for the lotion containers.
   2. Feed the containers through the labeling machine to apply labels uniformly.
   3. Ensure that labels are applied straight and adhere firmly to the containers.
3. Inspection:
   1. Visually inspect labeled containers to ensure labels are correctly applied and readable.
   2. Remove any containers with improperly applied labels from the production line.
4. Batch Information:
   1. Verify that each labeled container includes the correct batch number, expiration date, and any other required information.
   2. Document the batch details in the batch record.
5. Cartoning:
   1. Place labeled containers into cartons or boxes as per the packaging plan.
   2. Ensure cartons are sealed properly and labeled with batch details.
6. Storage:
   1. Transfer the labeled products to the designated storage area.
   2. Store products under appropriate conditions as specified (e.g., temperature, humidity).

4.3 Post-Operational Activities:

• Document the labeling activities in the batch record.
• Clean the labeling equipment and area according to the cleaning SOP.

5) Abbreviations, if any

None.

6) Documents, if any

• Batch Labeling Record
• Equipment Logbook
• Cleaning Record

7) Reference, if any

• Good Manufacturing Practice (GMP) guidelines
• FDA Labeling Guidelines

8) SOP Version

Version 1.0