SOP on Mix-ups & Cross Contamination during Packaging and Labeling Operations
1.0 Purpose: This SOP describes the guidelines to prevent mix-ups and cross contamination during packaging and labeling operations for manufacture of a drug batch
2.0 Scope: This SOP applies to Production operating and packaging staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: The potential for mix-ups and cross contamination may be reduced by following these instructions –
5.1 A physical barrier between adjacent lines.
5.2 Adequate space and physical segregation to assemble bulk product and packaging components.
5.3 Adequate space for assembly of finished packaged stock prior to transfer to warehouse.
5.4 Accumulation tables or other space to accommodate part packaged product in the event of temporary breakdown of part of packaging line.
5.5 Dust extraction over bulk table hoppers.
5.6 Cover over open hoppers, open empty containers, and filled but uncapped containers.
5.7 Avoidance of running different, but similar looking, products or packs on adjacent lines.
5.8 Delay start – up until all packaging components are available.
5.9 During extended stoppages, such as lunch breaks, and shift changes, ensure that all filled units are capped, especially for liquid products.