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1.0 OBJECTIVE:
To lay down the Procedure for Changeovers carried out in Manufacturing and Packing area.
2.0 SCOPE:
This SOP shall be applicable to the Batch to Batch and Product to Product Changeovers carried out for
area and equipments in manufacturing & Packing area at Production department.
3.0 RESPONSIBILITY:
3.1 Execution :Operator
3.2 Checking :Production Pharmacist & Above
4.0 ACCOUNTABILITY:
HOD-Production / Assigned Designee
5.0 PROCEDURE:
5.1 BATCH TO BATCH CHANGEOVERS
5.1.1 Batch to batch change over is change over from one batch of a product to another batch (next
batch) of the same product in granulation, Compression, Coating & packing section.
5.1.2 For individual equipment, first ensure that the process of that batch on that particular equipment
or area is complete, and the product is removed or has proceeded further for the next stage.
5.1.3 Remove the entire residual product like Granules, Fines, Tablets, and Strips etc. from the
equipment and the area.
5.1.4 Remove the status label of the previous batch.
5.1.5 Clean the equipment with the dry clean lint free cloth, nylon brush and use vacuum as per the
requirement.
5.1.6 Clean the accessory equipments like dust extractors and dehumidifiers in the area as per their
respective SCPs.
5.1.7 Affix the status label for the next batch. Get the area and the equipment certified by Q.A. person
and record it on the batch document of the new batch to be processed.
5.1.8 Start the processing of the new batch.
NOTE
At the start of the shift ensure the cleaning of in process equipments, if the batch is continued for
more than one shift.
If same product is continued for more than 3 days then cleaning of equipments & area as per
respective SCP & take line clearance from Q.A. Department.
Complete cleaning of the area & equipments after three batches (For Batch to Batch) & after every
batch (For Product to Product). Take Clearance of Q. A. department before work start.
Mentioned the type of cleaning as:
Type A : Product to Product change over.
Type B : Batch to Batch change over.
Type C : Shift end cleaning.
6.0 ABBREVIATIONS:
6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department