Follow
Line Clearance Before Dispensing
1. Before starting dispensing operation of a new Batch, approval of line clearance shall be obtained from the QAO.
2. For giving line clearance, QAO shall check the following parameters:
3. Check the area and equipment for cleanliness.
4. Check the working area for the absence of previous batch material and documents.
5. Check that the “CLEANED/STERILIZED” status labels of Machine and BMR are signed by Production Officer.
6. Check the raw materials to be dispensed for the correct status (approved) and correct identity.
7. QA officer shall give clearance by signing on the BMR, if above criteria are met.
Line Clearance Before Manufacturing
1. On receipt of the information from Production Officer that the area/equipment are cleaned and ready for next batch, QAO shall inspect the area and equipment for cleanliness and absence of materials and documents of previous batch.
2. QAO shall ensure that the “CLEANED AND STERILIZED” label and the BMR are signed by the Production Officer.
3. QAO shall ensure that the area is clean and free from previous batch materials.
4. Only in case of change over from one product to another product, QAO shall collect rinse samples from the manufacturing and storage vessels, which are to be used and test the sample for traceability of previous batch. The vessels should not have any trace of previous batch. If any traces of previous product are noticed, than QAO shall recommend for re-cleaning.
5. QA officer shall give clearance by signing on the BMR, if above criteria are met and the rinse sample meets the requirement. The test record (Form no. PM010-01) shall be compiled with the BMR.
Line Clearance Before Filling Operations
1. Before starting the filling of a new Batch, approval of line clearance shall be obtained from the QAO.
2. For giving line clearance, QAO shall check the following parameters:
3. Check the area and equipment for cleanliness.
4. Check the working area for the absence of materials/products and documents of previous batch; specially check for cleanliness of waste (dust) bins, underneath the machine.
5. Check Information Display Board for correctness of information.
6. Check that “CLEANED/STERILIZED” status labels of Machine and BMR is signed by AEO.
7. Only in case of change over from one product to another product, QAO shall collect rinse samples from the Filling Machine, which is to be used and test the sample for traceability of previous batch. The filling line should not have any trace of previous batch. If any traces of previous product are noticed, than QAO shall recommend for re-cleaning.
8. QA officer shall give clearance by signing on the BMR, if above criteria are met and the rinse sample meets the requirement. The test record (Form no. PM019-01) shall be compiled with the BMR.
Line Clearance Before Packaging Operations
1. Before the packaging operation of a new batch, the product name, batch no., mfg. date, exp. date and M.R.P. of the product under processing shall be checked by Production Personnel and Quality Assurance Officer.
2. Approval of line clearance shall be obtained from the QAO before starting the packaging operation.
For giving line clearance, QAO shall check the following parameters:
Check the area and equipment for cleanliness.
Check the working area for the absence of materials/products and documents of previous batch, especially check for cleanliness of waste (dust) bins, underneath the machine.
Check Information Display Board for correctness of information.
Check that “CLEANED/STERILIZED” status labels of Machine and BPR are signed by Production Officer.
Check that label, leaflet, aluminium foil and PVC foil, inner carton, dropper, holographic sticker and shipping carton used for the product under packaging, are correct.
3. A printed label shall be collected to check the batch no., mfg. date and exp. date. The QAO shall give his initial and date and place the label on the area marked as “AFFIX PRINTED LABEL” in form no. QA013-01. In case of ampoules, a pre-printed ampoule shall be collected and checked for the correctness of above information.
4. Also it shall be checked that the batch no., mfg. date, exp. date and M.R.P. printed on inner carton by jet printer are correct.
5. QA officer shall give clearance by signing on the BPR, if above criteria are met.
