SOP On Product Change Over during Manufacturing

• 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)

• Responsibility
  • 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.

• Procedure
• 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.

• Distribution
  • Master copy –  Quality Assurance
  • Controlled copies –  Quality Assurance, Production and Quality Control.
• History:

Date	Revision Number	Reason for Revision
	00	New SOP

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