SOP on Packaging and Labeling Operations Line clearance
1.0 Purpose: This SOP describes the guidelines for packaging and labeling line clearance for manufacture of a drug batch
2.0 Scope: This SOP applies to Production Supervisor and Operating staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: Before commencing a packaging operation it is essential to examine entire line to confirm that it is documented as having been cleaned.
5.1 That there is no visible evidence of bulk product, components or finished product from previous packaging run.
5.2 That line board notes the correct product, batch number and expiry date.
5.3 That correct materials have been delivered to line.
5.4 Results of these inspections should form part of batch records.