Standard Operating Procedure for Lotion Packaging

1) Purpose

The purpose of this SOP is to outline the standardized procedure for the packaging of lotions to ensure the integrity, safety, and quality of the final product.

2) Scope

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

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Packaging Operators:

• Carry out the packaging process as per the SOP.
• Ensure packaging materials are suitable and meet quality standards.

Quality Control Personnel:

• Inspect and verify the quality of the packaged product and packaging materials.
• Ensure compliance with packaging specifications and standards.

Packaging Supervisors:

• Oversee the packaging process to ensure adherence to the SOP and resolve any issues.

4) Procedure

4.1 Pre-Operational Checks:

• Ensure the packaging area is clean and sanitized.
• Verify the availability and condition of packaging materials (bottles, labels, caps, etc.).
• Ensure all packaging equipment is clean, calibrated, and in good working order.

4.2 Packaging Process:

1. Filling:
   1. Set up the filling machine according to the specified volume for the lotion.
   2. Ensure the lotion is at the correct temperature and homogeneity before filling.
   3. Fill the lotion into the containers as per the specified volume.
2. Sealing:
   1. Place caps or seals on the filled containers securely.
   2. Verify that the seals are intact and free from defects.
3. Labeling:
   1. Label each container with the appropriate product label, including batch number, expiration date, and other required information.
   2. Ensure labels are applied straight and adhere firmly to the containers.
4. Inspection:
   1. Inspect the packaged product for any defects or inconsistencies.
   2. Remove any non-conforming products from the packaging line.
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 packaged 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 packaging activities in the batch record.
• Clean the packaging equipment and area according to the cleaning SOP.

5) Abbreviations, if any

None.

6) Documents, if any

• Batch Packaging Record
• Equipment Logbook
• Cleaning Record

7) Reference, if any

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

8) SOP Version

Version 1.0