What is Line Clearance in Pharmaceutical Industries?

Line clearance is a crucial process in the pharmaceutical industry that ensures the safety and quality of products being manufactured. It involves a thorough inspection and verification of equipment, facilities, and materials before starting a new batch production or after completing a batch. The line ...

SOP for Line Clearance by Production

1.0 OBJECTIVE To describe the procedure for line sign-off and material verification prior to a production operation 2.0 SCOPE This procedure applies to all production operations including packaging and labeling to ensure that the correct materials, documents, and other requirements are in place prior ...

Line Clearance Checklist for Compression

– All extraneous materials & equipments/accessories except relevant to this batch are removed – Correct tooling is set in machine – Check and ensure that right IBC has been set up to right compression machine – Waste Bin is cleaned – All the equipment inside the room ...

Line Clearance Checklist for Coating

– All extraneous materials & equipments/accessories except relevant to this batch are removed – Waste Bin is cleaned – All the equipment inside the room including SS table utensils and scoops are cleaned – All materials/ equipments are labeled properly – All protective ...

Line Clearance Checklist for Primary Packing Area

– Quantity of inner carton for over printing to be determined on the basis of actual number of coated tablets received for blistering after coating – All protective clothing of printing personnel i.e. dress, shoes and caps are properly cleaned – All extraneous materials & equipment’s/accessories ...

Line Clearance Checklist for Granulation

All extraneous materials & equipments/accessories except relevant to this batch are removed Waste Bin is cleaned All the equipment inside the room including SS table utensils and scoops arecleaned All materials/ equipments are labeled properly All protective clothing of processing personnel i.e. ...

Line Clearance Checklist for Secondary Packaging Area

1 Ensure that product containers, materials, status labels, BPR of previous process operation are removed. 2 Ensure that area is cleaned as per the cleaning procedure and records are updated. 3 Ensure that temperature, relative humidity and differential pressure of the area is suitable for dispensing. 4 Ensure ...

Line Clearance

To ensure that the area and equipment to be used for dispensing of raw and packing materials, manufacturing and packaging of finished products are free from leftovers of previous product/ batch/ material. This procedure is applicable for conducting the line clearance at the dispensing, manufacturing, ...

Line Clearance Checklist for Packing (Liquid)

1. Check and ensure that the area/ equipment/ belt are visually clean. 2. Check the area is free from previous product and unwanted materials 3. Check the proper gowning of personnel. 4. Check the present status label which shows the details. 5. Verify the issued secondary packaging material with respect ...

Line Clearance Checklist for Coating

1. Ensure that product containers, materials, status labels, BMR of previous process operation and relevant documents are removed. Ensure that area along with respective equipments is cleaned as per the cleaning procedure and records are updated and within validity period as per production SOP. 2. Ensure ...
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