Standard Operating Procedure for Packaging in Cream Manufacturing
1) Purpose
The purpose of this SOP is to outline the steps required for the packaging of creams in a pharmaceutical manufacturing setting to ensure product integrity, compliance with regulatory standards, and prevention of contamination.
2) Scope
This SOP applies to all personnel involved in the packaging of creams within the pharmaceutical production facility. It covers the preparation, operation, and maintenance of packaging equipment and materials.
3) Responsibilities
It is the responsibility of the packaging team to follow this SOP accurately and ensure that all packaging processes comply with GMP standards. The packaging supervisor is responsible for overseeing the packaging process and ensuring proper documentation.
4) Procedure
4.1 Preparation of Packaging Materials and Equipment
4.1.1 Verify that all packaging materials (tubes, containers, labels, etc.) are available and meet the required specifications.
4.1.2 Ensure that all packaging equipment is clean, calibrated, and in good working condition.
4.1.3 Set up the packaging area according to GMP guidelines and ensure it is free from any contaminants.
4.2 Filling Process
4.2.1 Adjust the filling machine settings according to the specified volume or weight for each unit of cream.
4.2.2 Perform a trial run to ensure the filling accuracy and consistency.
4.2.3 Begin the filling process, ensuring that the cream is dispensed into each container accurately and without spillage.
4.2.4 Continuously monitor the filling process and perform in-process checks to ensure uniformity and consistency.
4.3 Sealing and Labeling
4.3.1 Once the containers are filled, proceed with the sealing process using the appropriate sealing equipment (e.g., tube sealer, capper).
4.3.2 Verify the integrity of the seals to ensure they are secure and free from leaks.
4.3.3 Apply labels to the containers, ensuring they are correctly positioned and adhered properly.
4.3.4 Perform random checks to verify that the labels contain the correct information (batch number, expiry date, etc.).
4.4 Secondary Packaging
4.4.1 Place the labeled containers into secondary packaging (e.g., cartons, boxes) according to the specified packaging configuration.
4.4.2 Ensure that the secondary packaging is intact and properly sealed.
4.4.3 Label the secondary packaging with the appropriate batch information and handling instructions.
4.5 Quality Control and Documentation
4.5.1 Perform final quality control checks to ensure that all packaged products meet the required specifications.
4.5.2 Document the packaging process in the batch record, including details of the equipment used, settings, and any deviations observed.
4.5.3 Record the quantity of products packaged and any wastage.
4.6 Cleaning and Maintenance
4.6.1 Clean the packaging equipment according to the cleaning SOP to prevent cross-contamination.
4.6.2 Perform routine maintenance and calibration of the packaging equipment as per the maintenance schedule.
4.6.3 Record all cleaning and maintenance activities in the equipment logbook.
5) Abbreviations, if any
GMP: Good Manufacturing Practices
6) Documents, if any
Batch Manufacturing Record (BMR)
Packaging Logbook
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0