Standard Operating Procedure (SOP)

Here is a detailed Standard Operating Procedure (SOP) for Line Clearance in the Manufacturing Area, which is critical for preventing cross-contamination, ensuring product integrity, and complying with cGMP guidelines.

1. Purpose

To establish a standardized procedure for line clearance before starting any new manufacturing activity to ensure that the area, equipment, and materials are free from remnants of previous batches and potential contaminants.

2. Scope

This SOP is applicable to all manufacturing areas, including granulation, blending, compression, coating, and packing areas in the facility.

3. Responsibility

• Production Officer/Executive: Perform initial line clearance and inform QA.

• Quality Assurance (QA): Verify and approve the line clearance before commencement of operations.

• Area Supervisor: Ensure compliance and documentation.

4. Definitions

• Line Clearance: The process of ensuring that all materials, documents, and residues from the previous batch/product have been removed before starting a new activity.

• Batch Record: Document that records all production and quality control data for each batch.

5. Materials and Tools Required

• Line clearance checklist/form

• Clean status labels

• Personal Protective Equipment (PPE)

• Cleaning tools and materials

• Torch/inspection light (if required)

6. Procedure

6.1 When Line Clearance is Required

• Before starting a new batch

• Changeover of product or strength

• After major maintenance or equipment breakdown

• After any cleaning activity

6.2 Steps for Line Clearance

1. Initial Preparation (Production):

   • Clean and sanitize all equipment and area surfaces as per the cleaning SOP.

   • Remove all materials, labels, documents, and waste from the previous batch.

   • Ensure that equipment is labeled as “Cleaned.”

   • Fill out the preliminary section of the Line Clearance Checklist.

2. Visual Inspection (Production):

   • Verify absence of previous product residue, unused labels, documents, and tools.

   • Check cleanliness of walls, floors, and ceilings.

3. Request QA Clearance:

   • Notify QA department after completing the initial checks.

   • QA performs independent verification using the Line Clearance Checklist.

4. QA Verification (QA Officer):

   • Inspect equipment, accessories, and area for cleanliness.

   • Confirm the removal of previous product materials and documents.

   • Verify cleaning records and “Cleaned” status labels.

   • Review environmental conditions if applicable.

5. Approval and Documentation:

   • If satisfactory, QA signs off the Line Clearance Checklist.

   • Attach the approved checklist to the Batch Manufacturing Record (BMR).

   • Production may begin operations only after QA clearance.

7. Precautions

• Do not start any process without QA-approved line clearance.

• Avoid mixing materials or documents from different batches.

• Use designated bins for rejected or leftover materials.

• Follow unidirectional flow of personnel and materials to avoid contamination.

8. Documentation

• Line Clearance Checklist/Form

• Batch Manufacturing Record (BMR)

• Equipment Cleaning Record

• QA Logbook (Line Clearance entry)

9. Abbreviations

• SOP – Standard Operating Procedure

• QA – Quality Assurance

• BMR – Batch Manufacturing Record

• PPE – Personal Protective Equipment

• cGMP – Current Good Manufacturing Practice

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