Line Clearance SOP


Line Clearance SOP






1.0   PURPOSE:

1.1.         To establish a procedure of line clearance before each and every stage of product manufacturing

2.0    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.

3.0   RESPONSIBILITY:


3.         Responsibility:                                                                                                  
3.1.      Section Supervisor
3.2.      QA Manager
3.3.      QA Officer


4.0    PROCEDURE:


4.         Procedure:                                                                                                                   
4.1.      QA receives “Request for Line Clearance” from Raw Material Store for dispensing of Raw Materials, makes entry in log book and dispensed the Raw Material as per SOP.
4.2.      QA receives “Request 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 log book:
4.3.1.   Date
4.3.2.   Product name,
4.3.3.   Batch number,
4.3.4.   Stage/process for which line clearance is requested,
4.3.5.   Then issue a LC number to that process/stage.
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.

5.0    QUALITY FORMS AND RECORD:

N-A





EVIDENCES OF RECORDS & REFERENCES
Log Book for Line clearance
Batch Manufacturing Records(BMRs)
FORMAL KPIs (Key Performance Indicators)
No. of Line Clearance issued per day
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN
Risks
Impact
Start of work without line clearance certificate.
Documentation of the batch record will not be verified.
Mix-ups
Contamination
Environmental hygiene issue
Ensure the presence of line clearance certificate during the whole process
If not present stop the line
Generate NCR against respective department and ask for the line clearance request










QA Officer/
QA Attendant/
All Section Supervisors
Wrong entries in line clearance log book (date/process name/LC number, etc).

Failure to find some old record in Line Clearance log book (during inspection or whenever a problem arises).

Place the line clearance log book at some visible site, so whenever a request receives make sure the proper entry for that
Removal of remnant is not done completely.

There are chances of mix-up of materials (Raw or Packaging) of two consecutive batches that have gone through the same process (optical inspection/blister/packing etc).

Assure the proper labeling on containers, shippers, trays and any other material that containing any type of raw or packaging material
Ask the section supervisor to remove the all remnant of previous product.



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