Handling and Transporting Tablets within the Manufacturing Department


1. Purpose

To outline the procedure for safe and compliant handling and transportation of tablets within the manufacturing department to ensure product integrity and avoid contamination or mix-ups.

2. Scope

This SOP applies to all personnel involved in the handling and internal transportation of tablets at various stages of processing (e.g., post-compression, coating, and before packaging).

3. Responsibilities

| Role                | Responsibility                                         |

| Manufacturing Staff | Follow the SOP during all handling and transportation. |

| QA Personnel        | Monitor compliance and perform periodic checks.        |

| Supervisors         | Train staff and ensure procedure adherence.            |

 4. Definitions

* Tablets: Solid oral dosage form containing medicinal substances.

* In-process material: Material undergoing processing, not yet a finished product.

* Clean area: Area maintained under controlled environmental conditions to prevent contamination.

 5. Procedure

 5.1 General Guidelines

* Ensure hands are washed and proper gowning is in place before handling tablets.

* Only trained personnel should perform tablet handling and transport activities.

* Verify all containers, tools, and equipment are clean and labelled.

 5.2 Handling of Tablets

* Handle tablets using clean, sanitized scoops or gloved hands if applicable.

* Avoid direct contact to minimize contamination.

* Do not place tablets directly on unapproved surfaces.

* Visually inspect for broken, chipped, or contaminated tablets; report discrepancies.

 5.3 Transport Equipment

* Use only dedicated, labelled, and cleaned containers or bins for transport.

* Ensure trolleys, bins, or containers are sanitized and inspected before use.

* All containers must have a legible status label indicating:

  * Product Name

  * Batch Number

  * Quantity

  * Status (e.g., Approved, Under Test)

 5.4 Transport Procedure

* Place tablets gently into the container to prevent breakage.

* Cover containers securely to prevent contamination during transport.

* Transport tablets only through designated routes and in accordance with material movement maps.

* Avoid stacking heavy items on containers carrying tablets.

* Prevent exposure to moisture, dust, or any chemical contaminants during movement.

 5.5 Receiving at Destination

* Upon arrival at the next processing or packaging area:

  * Inspect containers for any signs of damage or contamination.

  * Cross-check batch details with documentation.

  * Ensure storage conditions are appropriate until further processing.

 6. Documentation

* Record all handling and transport activities in the batch manufacturing record (BMR).

* Complete transport logbooks and cleaning checklists.

* Document any deviations or incidents immediately and inform the supervisor.

 7. Cleaning and Maintenance

* Clean transport equipment before and after use.

* Maintain cleaning logs for containers, trolleys, and related tools.

* Verify cleaning agents are suitable and approved for product-contact surfaces.

 8. Precautions

* Avoid rough handling or unnecessary movement.

* Immediately report any mix-ups, spillages, or cross-contamination risks.

* Follow line clearance procedures before reuse of transport equipment.

 


Post a Comment

0 Comments

Table of Contents