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By: ronakkpatel (106 month(s) ago)


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Slide 2: 

The procedures have been established to prevent mix-ups of products , container , component ,and labels and mistakes while preparing a product. Line clearance procedures is having three stages i.e. clearing , cleaning , checking.

Clearing:- : 

Clearing:- Remove the previous product related items from the area/line i.e. pre printed ampoules , plugs , left over solution/material , product , labels , printed cartons , batch coding , packed products , documents.

Cleaning:- : 

Cleaning:- Cleaning to be carried out only after clearing of previous products. Clean the as per current SOP. Clean the equipment as per current SOP and send the rinse water / swap to Q.C for analysis where required i.e. product change over.

Checking:- : 

Checking:- Checking to be carried out only after clearing and cleaning of previous products. Area/ line incharge ensure the clearing and cleaning. Then Q.A has to cross check the area / line. The same should be recorded in the BMR. Area / line clearance failure should be recorded in deviation format and Investigation to be carried out.

Slide 6: 

LINE CLEARANCE PROCEDURE IS APPLICABLE FOR THE FOLLOWING STAGES: 1) Dispensing 2)Decartoning 3)Washing and sterilization 4)Manufacturing and filtration 5)Filling 6)Leak test 7)Batch coding 8)Packing

Area/line clearance failure:- : 

Area/line clearance failure:- Any item , which could compromise quality , found during checking / in a subsequent batch is classified as a line clearance. The same to be informed to Q.A manager and stop the line until reasons are found and necessary action taken to avoid any mix-ups. Critical line clearance failure must be subjected to deviation report and to be investigated to identify the root cause.

Control of rejection:- : 

Control of rejection:- Rejected item should be kept in separate container with lid. Rejected status label (red color) should be described with details. Online rejected items should be kept in closed container with status label.

Slide 9: 

Line clearance to be carried out prior to commencement of same product different batch or different product. Check the effectiveness of line clearance after the restart of the operation after the break. Checking of any area line must not commence until all clearing and cleaning activities are complete and signed off. If the line is not used immediately after cleaning and clearing it must be rechecked immediately before start..

Slide 10: 

Trails , maintenance work and other activity which could hamper the clear and clear status of an line / area. The person responsible for line clearance must be informed of all such occurrences and before the area / line is cleared as suitable for production. After obtaining line clearance a status board of the activity in progress to be displayed or recorded and signed off.

Slide 11: 

The design of equipment and process areas shall be considered with respect to impact upon line clearance efficiency. Equipment design shall be assessed for potential rouge traps and these shall be designed out or minimized. Equipment shall be designed such that it is easy to dissemble and reassemble. Clear guards shall be used where possible to aid visibility.

Slide 12: 

The use of torches or flash lights , mirror can be useful to make all areas of the area / equipment as visible as possible. The process area shall have no excess furniture. Ex:- Benches , storage cupboards.

Live line clearance:- : 

Live line clearance:- ‘Live line clearance’ has been successfully used as a useful training tool for new operators or for the introduction of new equipment. It involves the placing of ‘dummy’ articles with in the area / line after the checking is completed. Operators are then asked to find the dummies. If all of the dummies are not found then this may indicate the need for further operator training or modification to the procedures or checklist.

Slide 14: 

The dummies should be placed in areas where clearing or checking are known to be a problem. If ‘Live line clearance’ is to be used then essential that strict , proceduralised control is in place. The dummies used should not be capable of being confused for the genuine article. Defaced genuine articles should not be used as dummies.

Slide 15: 

Dummies used should not be capable of being packaged or further processed. An example of an acceptable dummy is a colored plastic , magnetic. Strict , proceduralised reconciliation should be to the dummies and all dummies should be accounted for before production may resume.

Slide 16: 

Q.A personnel shall be given training for line clearance activity and evaluated for the effectiveness, also frequently twice in a year all Q.A in process personnel will be evaluated for line clearance activity effectiveness.

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Slide 18: 

Thank you

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