- SOP On Product Change Over during Manufacturing
- Objective:To lay down a procedure for the product Change Over during Manufacturing.
- Scope:This SOP is applicable for the product change over during manufacturing of product in the formulation of (Pharmaceutical company name)
- Production Operator/ Technician shall be responsible for operation of the machine.
- Production/IPQA Officer/ Executive shall be responsible for the implementation of the SOP.
- Accountability:Production and QA Head shall be accountable for compliance of SOP.
- Abbreviations and Definitions
SOP : Standard Operating Procedure.
BMR : Batch Manufacturing Record.
IPQA :In process Quality Assurance.
BPR : Batch Packing Record.
- Before starting the product change over first go through the SOP of cleaning and maintenance of equipment and line clearance.
- Perform the A type cleaning as per SOP.
- Switch “OFF” the utilities supply of equipment during cleaning, dismantling and assembling of machine parts.
- Product change over shall be done by trained production Operator and supervisor.
- Use the hand gloves & nose masks while performing the changeover.
- Ensure the absence of residue/material of previous batch executed.
- Ensure the availability of tools required for dismantling and assembling of equipment change parts.
- Procedure for dismantling and cleaning of equipment change parts.
- After completion of activity affix the status label “TO BE CLEANED” on the equipment.
- Ensure that tools required for dismantling of equipment change parts are available.
- Clean the outer and inner surface of the equipment with lint free dry duster followed by wet duster.
- Dismantle the equipment change parts with the help of appropriate tools.
- Place the dismantled machine parts on pallets and wipe with dry duster.
- Keep the dismantled machine parts in polybag.
- Affix the status label “TO BE CLEANED”.
- Transfer the equipment change parts to washing area by using trolley and IPC bins.
- Clean the equipment change parts in manufacturing.
- After completion of cleaning perform the swab testing (if applicable).
- Wrap the cleaned change parts with clean cling film.
- Before transfer of change parts to respective area, ensure that area has been cleaned as per area cleaning SOP.
- Transfer the equipment change parts to respective area for assembling if required.
- Transfer the Equipment change parts to change parts storage room if not required to perform the production activities.
- Procedure for Area and Equipment Cleaning
- Follow the respective SOP for area cleaning
- Ensure that there is no residue/Material of previous product lying on the floor.
- Ensure that there is no dust particles on the floor, walls, panel and ceiling.
- Clean the riser filter of the area as per respective SOP.
- Follow the Respective equipment cleaning SOP for the equipment cleaning.
- Ensure that there is no residue/Material of previous product lying on the surface of equipment.
- Ensure that equipment has been cleaned as per respective equipment cleaning SOP.
- Affix “CLEANED” label on the equipment.
- After completion of the cleaning process, record the cleaning time of the equipment in “Equipment Operation, Cleaning & Maintenance Log Book”
- Procedure for Swab Analysis
- After completion of the cleaning, production/officer executive shall inform the IPQA for swab collection.
- IPQA officer/Executive shall collect the swab sample of equipment and send to QC for testing.
- QC personnel shall perform the analysis as per standard testing procedure and prepare a swab analysis report.
- IPQA personnel shall collect the swab analysis report from the QC and hand over to production department.
- If result of the swab analysis is passed, start the assembling of machine parts.
- If result of the swab analysis is failed, re-clean the equipment change parts.
- Procedure for Assembling of equipment change parts
- Ensue that result of swab analysis has been passed
- Ensure the sterilization report of change parts used in aseptic area.
- Ensure the availability of required tools for assembling of equipment machine parts.
- Start the assembling of equipment change parts as per sequence.
- Tighten the nut and bolts properly.
- Wipe the outer surface of the equipment with dry duster.
- Take a line clearance for area and equipment for batch processing as per SOP.
Precautions:Product Change over includes
- Dismantling of equipment change parts
- Cleaning of Equipment and equipment change parts
- Cleaning of area adjacent to equipment
- Assembling of machine change parts
- Swab analysis
- Line Clearance
- List of Annexure / Format: Not Applicable.
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production and Quality Control.
Reason for Revision
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