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
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