Product Change Over Procedure Standard Operating Procedure is for avoiding product mix-up & cross contamination.

Product Change Over Procedure of PURPOSE

To avoid product mix-up & cross-contamination as per cGMP.

SCOPE

This procedure is to be followed for change over of products for manufacturing operations.

RESPONSIBILITY 
  • Incharge Pharmacist
  • Production Manager
  • Quality Assurance Manager
PROCEDURE 

At the completion of manufacturing operations, dismantle the machine.

Remove (if any) leftover powder, bottles, vials, seals, capsules etc. from the area.

Clean and sanitize / sterilize / disinfect the machine parts and area as per relevant for next day.

Adjust / assemble the required sterilized / sanitized / disinfected machine parts & check the machine for proper assembling.

When satisfactory prepare the area / machine as per relevant SOP for next day operation.

Inform Quality Control Department to perform area monitoring test for viable and non-viable particles.

Next product will only be processed if the area is cleared by the Quality Control Department.


QUALITY FORMS AND RECORDS


Line clearance records are attached in BMR.

DISTRIBUTION

  • Head of Operation
  • Q.A Manager
  • Production Manager
  • Q.C Manager
  • Production Pharmacist