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PHARMA BROADCAST
UNIT/DEPARTMENT PRODUCTION
DOCUMENT TITLE Sop for the Line Clearance in Manufacturing area
SOP No: Supersedes: Effective date:
Document Type: Revision No.: Revision date:

1. OBJECTIVE:
To define the procedure for Line Clearance in Manufacturing area
2. SCOPE:
This procedure is applicable for Line Clearance in Pharma Broadcast Pharmaceuticals
3. RESPONSIBILITY:
Production & QA
4. ACCOUNTABILITY:
QA Head
5. PROCEDURE:
5.1. Manufacturing area is first checked by the Production Personnel
5.2. If the area is found appropriate, production personnel should inform the IPQC
personnel for Line Clearance.
5.3. After receiving the information from the production, IPQC person should check the
area, equipment and documents as per the line clearance Check List provided in BMR.
5.4. IPQC personnel should check the following points.
I. Ensure that the area and equipment is visually clean
II. Ensure the pressure difference between the areas is within the specified limit.
III. Ensure that the area is clean and no any material (raw/Intermediate) of previous
product is present in the area.
IV. Ensure the status label of the previous product is removed and new status label
is attached
V. Ensure that the analysis report of the previous stage is approved by QC.
VI. Ensure the area is free from any type of waste material.
VII.Ensure that BMR is complete up to the current stage.
VIII. Ensure that the equipment is clean and free from previous product, Ensure
the equipment is dry in case of manufacturing of tablet
IX. Ensure all the equipment and change parts are fixed accordingly to the
instruction given in the BMR.

Prepared by: Checked by: Reviewed by: Approved by:

Signature/Date: Signature/ Date: Signature/Date Signature/Date

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PHARMA BROADCAST
UNIT/DEPARTMENT PRODUCTION
DOCUMENT TITLE Sop for the Line Clearance in Manufacturing area
SOP No: Supersedes: Effective date:
Document Type: Revision No.: Revision date:

X. Ensure the temperature and spray rate is according to BMR in tablet coating
XI. Ensure proper gowning is done by the person
XII. Ensure that AHU is working properly and AHU return filter is properly cleaned.
XIII. Ensure that the floor, celling and wall is properly clean and free from
powder particles
XIV. Ensure that the Temperature and humidity is in the range as given in BMR
XV. Ensure that the weighing balance is calibrated.
XVI. Check the integrity of sieve.
5.5. If there is any material from the previous product, the cleaning procedure should be
re-performed until all the equipment and area is cleaned properly
5.6. If the visual inspection is ok then only continue the procedure.
5.7. Check for the swab/rinse report from the QC department.
5.8. If the swab/rinse report is approved and all the documentation is done properly
then IPQC personnel should give the line clearance as per BMR and simultaneously
sign in the BMR.
6.Enter the Equipment/ Equipment Log Book as appropriate
7. ANNEXURE:
Nill
8. ABBREVIATION:
SOP : Standard Operating Procedure
BMR : Batch Manufacturing Record
BPR : Batch Packing Record
IPQC : In Process Quality Control

9. REVISION HISTORY:

Prepared by: Checked by: Reviewed by: Approved by:

Signature/Date: Signature/ Date: Signature/Date Signature/Date