SOP for Line clearance

Objective To ensure that the area and equipment to be used for the dispensing, manufacturing and packing of products are free from remnants of previous product/batch.

Scope This procedure is applicable for clearance of dispensing, manufacturing, packing area & equipments.

Responsibility
=>> IPQA Officer / Production Officer / Dispensing Officer.

Procedure
=>> For change over from one batch to another batch of same product or ascending strength of same product provided colour is same.
=>> On receipt of the information from Production officer that the area/equipment are cleaned and ready for next batch, inspect the area and equipment for cleanliness and presence of previous batch materials like stage labels, rejections, empty bulk containers etc. The area and equipment shall have not more than traces of previous batch.
=>> Ensure that on “Cleaned” labels & Batch production record (BMR & BPR) is signed by Production / Dispensing Officer.
=>> Ensure that the area is clean and free from previous batch materials especially check for cleanliness of waste (dust) bins, underneath the machine, dust collectors, vacuum pumps & FBP/FBD bags etc.
=>> Check the equipment and related assembly line thoroughly for cleanliness and presence of previous batch material. Equipment shall have not more than traces of previous batch. Give special attention to parts where there is possibility of retaining previous material.
=>> IPQA officer shall give clearance by signing on the “CLEANED” label & Batch production record (BMR & BPR), if above criteria are met.
=>> Incase lack of cleanliness is observed do not certify the area/equipment unless the same is properly cleaned.
=>> For change over from one product to another product or same product with descending strength or different colour
=>> On receipt of information from Production officer that the area/equipment are cleaned and ready for the start of next production run, inspect the area and equipment for cleanliness. The area and equipment should be free from any traces of previous run.
=>> Ensure that on “Cleaned” labels & Batch production record (BMR & BPR) is signed by Officer Production / dispensing.
=>> Ensure that the area is clean and free from previous batch material especially check for cleanliness of waste (dust) bins, stage labels, rejections, empty bulk containers and area where material accumulation can take place like underneath the machine, dust collector, vacuum pumps etc.
=>> Inspect the equipment and its parts thoroughly including related assembly line for cleanliness. Equipment should be free from any traces of previous product. Give special attention to all the contact parts, which are difficult to clean.
=>> Ensure filter in return duct of AHU is cleaned & check filter cleaning record.
=>> IPQA Officer shall collect swab or rinse sample from respective equipment, which are to be used and forward the sample to QC for testing.
=>> After release from QC, IPQA officer shall give the clearance by signing on the “CLEANED” label & Batch production record (BMR & BPR), if above criteria are met.
=>> Recommend for re-cleaning if any traces of previous product are noticed.

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