LOGFILE No. 43/2016 – Line Clearance

The EU GMP Guidelines Part I state in Chapter 5.45: “Before packaging operations are begun, steps should be taken to ensure that the work area, packaging lines, printing machines and other equipment are clean and free from any products, materials or documents previously used, if these are not required for the current operation. The line-clearance should be performed according to an appropriate check-list.“

Please refer to Figure 1 for an example of an appropriate check list.



Figure 1 Line clearance check list

This control procedure must be defined in properly authorised packaging instructions. This procedure is referred to as line clearance in the GMP Guidelines Part I Chapter 4.19. Line clearance is a structured procedure for ensuring that the equipment and work area are free of products, documents and materials from the previous process that are not required for the next scheduled process, and that the equipment is clean and ready for the next scheduled process.

An important element in the avoidance of cross-contamination, mix-ups and substitutions during packaging is systematic cleaning of the packaging line. This involves cleaning up remaining bulk product according to the valid cleaning instructions and removal of loose packaging materials belonging to the previous batch. The cleaning process and subsequent line inspection have to ensure that neither bulk product (e.g. loose tablets, capsules or bottles) nor packaging materials (e.g. package leaflets, folding cartons or labels) from the previous packaging process find their way into subsequent packaging processes. The procedure must be clearly defined in an SOP. The SOP must specify when and to what extent the procedure must be carried out. The machine-specific guidelines must be clearly formulated to exclude the possibility of staff interpreting them incorrectly. The machine-specific critical parts can be listed in a check list. Product transfers can only be excluded if this SOP is adhered to in detail. Not only the machine itself, but the surroundings/room where the utensils, remnants and containers are stored, must be assessed in accordance with the SOP. Samples removed during the packaging process must also be systematically removed. The process description must state who is responsible for carrying out and checking the individual steps of the cleaning process. For example, production personnel can be responsible for cleaning and dismantling, persons responsible for the in-process controls (also frequently referred to as line inspectors) can be responsible for controls and release. The completed check list is enclosed in the batch documentation of the following product as proof of implementation.

The GMP Series PDF Download GMP Compliance Basics of Packaging Materials and Processes provides you with a step-by-step guidance through all you need to know about
Packaging materials:

• packaging requirements
• different packaging materials
• storage and labelling of packaging materials
• specifications and testing of packaging materials
• protection against counterfeits

Packaging process:

• provision of packaging materials
• line clearance
• line setup and line release
• production and in-process controls
• reconciliation
• completion of a packaging process

Authors:

Ruven Brandes
Wirtschaftsgenossenschaft deutscher Tierärzte eG (WDT), Garbsen

Dr. Christian Gausepohl
Rottendorf Pharma GmbH, Ennigerloh