Follow
1.0 OBJECTIVE To describe the procedure for line sign-off and material verification prior to a production operation
2.0 SCOPE This procedure applies to all production operations including packaging and labeling to ensure that the correct materials, documents, and other requirements are in place prior to starting the operation.
A line clearance is performed for each production operation and on each day in the event the operation goes beyond one day.
3.0 RESPONSIBILITY
3.1 All personnel engaged in production operations are responsible for preparing the production area for line clearance inspection.
3.2 Quality Control personnel are responsible for performing a line clearance according to this procedure as requested by production personnel.
4.0 ACCOUNTABILITY
4.1 Manager Production or his nominee.
5.0 PROCEDURE
5.1 General Instruction
5.1.1 A line clearance is performed for each production operation and on each day in the event the operation goes beyond one day.
5.1.2 Prior to the production operation, determine the suitability of the gowning, environmental controls, processing line, equipment, and materials.
5.2 Line clearance preparation procedure
5.2.1 Remove all documentation, materials, and equipment from the previous production operation.
5.2.2 Clean the line and associated equipment according to established procedures.
5.2.3 Complete all appropriate entries into logs (Form No. PR008-00 and PR009-00) for area and equipment maintenance and also calibration record.
5.2.4 Enter data in room logbook (Form No. PR008-00) and get it checked by Quality Assurance.
5.2.5 Place only documentation, materials, and equipment designated for the scheduled production operation in the area.
5.2.6 Check gowning supplies and proper gowning of personnel.
5.2.7 Verify environmental controls are operational and within established limits.
5.2.8 Notify Quality Assurance and request a line clearance check for the area.
5.2.9 Obtain a Line Clearance Checklist (Annexure – I for manufacturing area, Annexure – II for weight checking and Annexure – III for packaging area) and complete the top section for operation name, date, Batch number.
5.2.10 Review each of the requirements listed on the form.
5.2.11 Initial the “yes” column if the requirement is met.
5.2.12 Initial the “No” column if the requirement is not met and describe the specific condition in the comment section. Notify the Manufacturing Supervisor, or designate, to correct the condition or resolve the discrepancy.
5.2.13 If the discrepancy cannot be resolved, complete a Discrepancy Report.
5.2.14 At the completion of the inspection, sign and date the form. Attach the form to the history record for the production lot.
