Standard Operating Procedure for Powder Packaging

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the packaging of powders in the pharmaceutical manufacturing process to ensure product integrity, quality, and compliance with regulatory requirements.

2) Scope

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

3) Responsibilities

Packaging Operators: Responsible for following the SOP and ensuring all packaging steps are accurately performed.
Packaging Supervisors: Responsible for overseeing the packaging process and ensuring compliance with the SOP.
Quality Control: Responsible for verifying that the packaged products meet the required specifications.

4) Procedure

1. Preparation:
   1. Ensure all packaging equipment is clean, calibrated, and ready for use.
   2. Verify the availability and quality of packaging materials (e.g., containers, seals, labels).
2. Weighing and Filling:
   1. Weigh the powder to be packaged using a calibrated balance.
   2. Fill the containers with the weighed powder using the appropriate filling equipment.
   3. Ensure uniform filling to avoid any discrepancies in quantity.
3. Sealing:
   1. Seal the containers using the appropriate sealing method (e.g., heat sealing, induction sealing).
   2. Ensure that the seals are intact and secure.
4. Labeling:
   1. Label each container with the necessary information, including batch number, expiration date, and any other required details.
   2. Verify that the labels are correctly placed and legible.
5. Quality Control Checks:
   1. Perform quality control checks on a sample of the packaged products to ensure they meet the specified standards.
   2. Check for uniformity in weight, sealing integrity, and labeling accuracy.
   3. Document the results of the quality control checks.
6. Storage and Handling:
   1. Store the packaged powders in a designated area with appropriate environmental controls (e.g., temperature, humidity).
   2. Ensure proper handling to avoid any damage to the packaged products.
7. Documentation:
   1. Complete all necessary documentation, including the batch packaging record.
   2. Ensure that all records are accurate and complete.
8. Cleaning:
   1. Clean the packaging equipment and area according to the cleaning SOP.
   2. Ensure that all residues are removed to prevent cross-contamination.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Batch Packaging Record

7) Reference, if any

Regulatory guidelines as per FDA, EMA, and other relevant authorities.

8) SOP Version

Version 1.0