MAN-055 Procedures for Line Clearance, Line Opening and Line Cleaning

Appropriate protective equipment must be worn when cleaning with 70% IPA.

1. General

1.1.             A Line Clearance, Line Opening and Line Cleaning is required with a change of batch production.

1.2.             A Line Clearance is done BEFORE a batch starts.  This is followed by a Line Opening.  Line Cleaning is carried out after the batch is completed – it is the last step in the process.

1.3.             Line Clearance, Line Opening and Line Cleaning checklists are on one Form.

1.4.             Each Process will have a specific checklist / form for each line or area.  The layout and sequence of these forms will be the same.

1.5.             If for any reason this procedure cannot be followed a DR is to be raised (see SOP QMS-035) and Management approval is to be sought prior to continuation of the line.

1.6.             Controlled Stoppages

1.6.1.       At the stoppage of a process, e.g. overnight or the weekend, the area must be made tidy and clean.  A Line Clearance is not required on re-commencement of the BPN.

1.6.2.       Narcotic manufacture
If product must be stored in the safe overnight or on weekends a cleaning procedure and checklist is completed to ensure all product is placed into the safe.

A count of product is to be recorded on a Work in Progress Transport Checklist.  When the product is returned to the packing area a Line Clearance product check against the WIP Transport sheet and Line Opening is to be completed before commencement of BPN.

1.6.3.       Incomplete batch
When an incomplete batch is removed from the line to another area for storage, the batch components must be counted and recorded.  When the product is returned to the Packing area, the count is checked and a Line Clearance and a Line Opening performed.

1.6.4.       Maintenance
Any Engineering/Electrical/Maintenance staff must request/notify the Production Manager if work maintenance is to be carried out during a controlled stop.  The Line Clearance, Line Opening and Line Cleaning must be carried out after completion of maintenance unless the Area Manager does not feel it is warranted as the work carried out presented no risk and all involved are aware of GMP.

1.7.             Generation of Checklists

1.7.1.       The current version of checklist forms (Form-160) are controlled and maintained as per SOP QMS-015.

1.7.2.       Checklists are not to be stored or photocopied and are to be generated on a needs basis, i.e. a copy to be printed off just before it is needed.

2. Line Clearance

2.1.             A Line Clearance must be done in areas where there is a risk that product and materials can be left on the line.  The responsibility of deciding where a Line Clearance is needed remains with Quality Manager.

2.2.             A “Line Clearance in Progress” Sign (VD-010) must be obtained from the area Managers’ Office and placed in a clearly visible position, before beginning the Line Clearance.

2.3.             A Line Clearance is done prior to an operation start-up or after a controlled stoppage.

2.4.             The Line Clearance form must be filled out as the check is carried out.  It is to be signed by two authorised persons.  The second check must be done after the first check.

2.5.             If the checklist is half done, and another operator takes over, they must redo the whole procedure before signing.

2.6.             Components must be removed from the Production Line.  (See section 6, ‘Exceptions’.)

2.7.             Batch documentation can only be signed off after the line clearance has been completed and signed.

2.8.             If there are any non-compliances found during the Line Clearance check then these MUST be completed:

a. Record in the Non-Compliance Table on the checklist

b. Record in the Non-Compliance Logbook; and

c. Report to and give non-compliance to the area Manager; and

d Communicate to the Team.

NOTE:
A Non-Compliance found, other than from the BPN just completed, must be recorded as above and a DR must be raised immediately as per SOP QMS-035 and the Area/Production Manager notified immediately.

2.8    If a foreign product/material is found during a production run then these MUST be completed:

a. Stop the line immediately,

b. Record in the Non-Compliance Logbook;

c. Report to and give to the area Manager immediately.

d. Raise a DR

e. Communicate to the Team.

3. Line Opening

3.1.             A Line Opening is carried out after a Line Clearance has been completed and signed to ensure that all related components, machine settings, BPN, Expiry Date, Date of Manufacture (if required) and information boards are all correct and complete before Production starts.

3.2.             Layout of Line Opening checklist must be used in conjunction with Batch Documents (MI sheet Phases).  It will ensure that the components are correct.  A sample of each component is to be taken and attached to appropriate sample sheet (Form-120).  Each sample is to be entered in relevant section of MI Sheet and, upon confirmation of correct details, the sample is ticked, signed and dated by each person carrying out Line Opening.  Each and every Laboratory Batch No. must be sampled and checked in the same manner.

3.3.             The Line Opening form must be completed and signed by two Authorised Persons as the process is carried out.  The Line Opening checklist and other batch documentation must be completed before production starts.  All components must be checked according to SOP MAN-045.  All printed materials must be sampled.

3.4.             NOTE:
If an additional issue of components is brought into the area during a process run, the components MUST be checked correct against the batch documentation and entered into the MI sheet.  A sample must be taken of all printed materials, signed, and attached to Sample sheet (Form-120).

3.5.             Product must be checked for correct details (Batch, Expiry, embossing and product details) during a Line Opening.

4. Line Cleaning

4.1.             The Line Cleaning form must be signed by an Authorised Person.  More than one Team member may clean and clear the line, but it is the responsibility of the Operator trained and assessed in Line Cleaning to ensure that the tasks have been performed and the Line Cleaning Checklist signed.  Some guards and parts may be removed and left open, or off, so that the Line Clearance for the next operation can be completed.

4.2.             Following the completion of an operation the product and process documents must be removed from the area, together with any remaining materials from that operation.  (See section ‘Exceptions’ below.)

4.3.             The line and /or the machine must be cleaned in accordance with the relevant SOP for the process.

4.4.             Components may be left on the Line.  (See section ‘Exceptions’ below.)

4.5.             The cleaning checklist should not be signed until the cleaning and housekeeping standards are met as documented in relevant SOPs for each piece of equipment.

5. Training and Assessment

5.1.             To sign a Line Clearance, Line Opening and Line Cleaning checklist, the operator must undertake theory training run by an accredited trainer and be assessed on the required line prior to signing a Line Clearance, and/or Line Opening and/or Line Cleaning checklist for a specific line.

5.2.             Following the successful completion of the training, employee must complete a supervised assessment using the actual Line Clearance, Line Opening and Line Cleaning checklist.  A separate assessment must be done for each function.
All training and assessment records must be sent to file in employee’s training file.

6. Exceptions

6.1.             Components can remain on the equipment providing usage can be calculated for Process Orders and providing removal of components is not part of the documented procedure.

6.2.             Exceptions as listed on the Line Clearance, Line Opening and Line Cleaning forms.

7. Summary of Changes