
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.
|
* 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.
* 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.
* 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.
* 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)
* 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.
* 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.
* 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.
* 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.
* 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.
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