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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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube