SOP Guide for Pharma

SOP for Labeling of Lotions

SOP for Labeling of Lotions

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:

Quality Control Personnel:

Labeling Supervisors:

4) Procedure

4.1 Pre-Operational Checks:

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:

5) Abbreviations, if any

None.

6) Documents, if any

7) Reference, if any

8) SOP Version

Version 1.0

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