Standard Operating Procedure of Line Clearance in Pharmaceuticals Plant is describe in this post.
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1. Purpose:
1.1. To establish a procedure of line clearance before each and every stage of product manufacturing.
2. Scope:
2.1. This procedure is applicable to all stages of a product from dispensing of raw material to final packaging of the product being manufactured in Pharmaceuticals.
3. Responsibility:
3.1. Section Supervisor
3.2. QA Manager
3.3. QA Officer
4. Procedure:
4.1. QA receives “Verbal intimation for Line Clearance” from Raw Material Store for dispensing of Raw Materials, makes entry in BMR and dispensed the Raw Material as per SOP.
4.2. QA receives “Verbal intimation for Line Clearance” from Production Department before starting of each process of respective product from Batch Manufacturing to Final Packaging.
4.3. QA Officer documents in Line clearance which is the part of BMR.
4.4. Within 10-15 minutes of receiving request QA Officer will inspect the area for which line clearance has been requested, assures the general cleanliness, checks temperature and humidity and ensures that the batch documents are available with complete information up to respective process.
4.5. Line clearance will be issued after inspecting the area/line as per below mentioned procedure:
4.6. GENERAL:
4.6.1. Check that there must be no remnant of the previous product at place where the process is going to start.
4.6.2. Ensure that AHU is running and differential pressure is maintained in area (where applicable).
4.6.3. Check floor, walls, windows, containers, uniform and ceiling for proper cleaning.
4.6.4. Check the temperature and Relative Humidity.
4.6.5. Check product name, batch no., mfg. date, exp. Date with cross reference.
4.7. ORAL SOLID DOSAGE FORMS (OSDs): (TABLET/CAPSULE)
4.7.1. Ensure RO water/rinse water release/report of mixing tank from QC department, before line clearance issuance for batch manufacturing.
4.7.2. Ensure proper/required temperature for tray drying,
4.7.3. Verify that the batch has been completely dried before dry granulation and final mixing.
4.7.4. Issue line clearance before withdrawing a sample for tablet compression/capsule filling, and start the operation as soon as the QC department releases the samples at bulk mixing and start of compression/capsule filling; and fill the weight control sheet as attached in BMR.
4.7.5. Ensure release/report of tablets from QC department after coating, before starting of blistering stage; also perform a blister leakage test before start of blistering.
4.8. LIQUID SYRUPS/SUSPENSIONS:
4.8.1. Ensure RO water/rinse water release/report of mixing tank from QC department, before line clearance issuance for batch manufacturing.
4.8.2. Ensure Bulk mixing release/report before withdrawing sample for syrup/suspension filling.
4.8.3. Issue line clearance before taking sample for syrup/suspension filling, and start the operation as soon as the sample released by QC department; also fill volume control sheet as attached in BMR for in process volume control.
4.9. PRINTING & PACKING:
4.9.1. Ensure the batch No. Mfg Date, Expiry Date and price for overprinting of unit cartons/ blisters/labels etc, sign the sample specimen followed by signatures from production department.
4.9.2. Sign the line clearance, as attached in BMR write the previous product along with batch number and all other information written on line clearance certificate allow starting the line/process.
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