Procedure for Line Clearance Before Commencing any Manufacturing Operation

Know the procedure for the line clearance checklist in different manufacturing departments before starting the manufacturing operation as per GMP.

1.0 Line clearance prior to dispensing

1.1 Check the dispensing area for the following:
1.2 All materials from previous operations have been removed.
1.3 Equipment and accessories from previous operations have been removed.
1.4 Paperwork from previous operations has been removed.

1.5 Status labels from previous operations have been removed.
1.6 The reverse laminar flow booths and surrounding are clean and status is displayed.
1.7 All the equipment and accessories required for dispensing are clean and labeled as such.



2.0 Line clearance prior to sifting / granulation / blending / compression / capsule Filling/ tablet inspection/ tablet coating / capsule Inspection and polishing

2.1 Check the areas for the following:
2.2 All materials and residues from previous operations have been removed.
2.3 Utensils and accessories from previous operations have been removed.
2.4 Containers used for previous operations have been removed.
2.5 Paperwork from previous operations has been removed.
2.6 Status labels from previous operations have been removed.
2.7 All equipment is clean and labeled as such.
2.8 Areas are clean and status is displayed.

3.0 Line clearance prior to overprinting

3.1 Check the area for the following:
3.2 All materials from previous operations have been removed.
3.3 All stereos from previous operations have been removed.
3.4 Paperwork from previous operations has been removed.
Related: SOP for Line Clearance in Manufacturing Area

4.0 Line clearance prior to primary and secondary packaging

4.1 Check the area for the following:
4.2 All materials and residues from previous operations have been removed.
4.3 Containers used for previous operations have been removed
4.4 Paperwork from previous operations has been removed.
4.5 Status labels from previous operations have been removed.
4.6 All stereos from previous operations have been removed.
4.7 All equipment is clean and labeled as such.
4.8 Areas are clean and status is displayed.





is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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