3. 1 Clearing
Remove all the previous work related items from
area / line like printing carton , foil, tablet
capsule packed product , documents
Responsibility supervisors to make all sure of the
previous work related product ,documents etc.
Officer and senior to cross check
4. Clean area / line up to the maximum possible
extent
Cleaning to be done only after Clearing
Responsibility :
supervisors ,officer & team leaders
5. Two type of cleaning.
A Type cleaning
Batch to Batch
Example:. Ridmox – 500
B.No. RID-1801 and next batch RID-1802
B Type cleaning
Product to Product
Example:. Ridmox -500 after next product
Nimucold
In case continue 5 batch running same product next batch B Type cleaning
6. Check and fill Line clearance document Like
BMR ,BPR, Logbook
Checking to be carried out only after clearing and
cleaning of previous product.
QA Person check and insure all check point
Then line clearance
Area line clearance failure should be recorded in
the same line clearance from after stopping
/closing line the line and inform to immediate
team leader
7. Check all dispensed area and equipment clean
Check Dispensing booth properly cleaned
Check that the documents of previous batch are removed.
Check RALF cleaned and check all filter clean riser clean
Check RALF dispensing start before for 15 minute
Check and ensure that the return air filter of the AHU is clean and fitted properly.
Check all status updated
Check the type of cleaning
A type cleaning = Batch to Batch
B type cleaning = Product to Product
Check after continue five batch and hold area 72 hour after B type cleaning
Temperature and humidity maintained according Temperature 25 ± 2 °C. And Humidity 50 ± 5 %.
Check all material Release to QC dept.
Check AR. NO. B.NO. Material Name and QC Release status label
Check and ensure that all the employees of the respective area are in proper gowning
Check and ensure that the waste bin is cleaned
Check and ensure that Scoops/Spoons, gloves, poly bags and containers are available in clean and dry
condition.
Check balance verification and calibrated
Check before cleaning TO BE CLEANED Label and after cleaning CLEANED label updated
Check all logbook updated.
After ensuring the above check points and other points (if any) as per the respective product, the IPQA
Chemist/ Officer shall give the line clearance for the Dispensing area.
8. Check all area cleaned
Check all status board updated
Temperature and humidity maintained according Temperature 25 ± 2 °C. And Humidity 50 ± 5 %.
Check all material verified material name and weight
Check the cleanliness of the Granulation area.
Check the type of cleaning
A type cleaning = Batch to Batch
B type cleaning = Product to Product
Check after continue five batch and hold area 72 hour after B type cleaning
Check before cleaning TO BE CLEANED Label and after cleaning CLEANED label updated
Check all previous product document removed
Check all equipment’s and utensils of the granulation area are clean.
Check and ensure the identification of the area and equipment with status labels.
Check and ensure that suitable poly bags and containers are available in clean and dry condition.
Check weights of the raw materials and verify in the respective product BMR.
Check all logbook updated
After ensuring the above check points and other points (if any) as per the respective product, the IPQA Chemist/
Officer shall give the line clearance for the granulation area.
9. Check all status board updated
Temperature and humidity maintained according Temperature 25 ± 2 °C. And Humidity
50 ± 5 %.
Check the cleanliness of the manufacturing area.
Check that the material and documents of the previous batch/ product are removed
Check the type of cleaning
A type cleaning = Batch to Batch
B type cleaning = Product to Product
Check after continue five batch and hold area 72 hour after B type cleaning
Check that the granulated material of the respective batch is released by QC department
and bears the release labels inside and outside of the container.
Check before cleaning TO BE CLEANED Label and after cleaning CLEANED label
updated
Check and ensure the identification of the area and equipment with status labels.
Check and ensure that all the employees of the respective area are in proper gowning.
Check weights of the granulated material and verify in the respective product BMR.
Check and ensure fill all logbook and updated status board
After ensuring the above check points and other points (if any) as per the respective
product The IPQA Chemist/ Officer shall give the line clearance for compression by
signing the section “Line clearance for compression” of the BMR.
10. Check all status board updated
Temperature and humidity maintained according Temperature 25 ± 2 °C. And Humidity 50 ± 5 %.
Check the cleanliness of the manufacturing area.
Check that the material and documents of the previous batch/ product are removed.
Check uncoated tablets of the respective batch is released by QC department and bears the release
labels inside and outside of the container.
Check the type of cleaning
A type cleaning = Batch to Batch
B type cleaning = Product to Product
Check after continue five batch and hold area 72 hour after B type cleaning
Check that all the equipments and spray gun set of the coating area are clean
Check and ensure that the return air filter of the AHU is clean and fitted properly.
Check and ensure the identification of the area and equipment with status labels.
Check and ensure suitable poly bags and containers are available in clean and dry condition.
Check and ensure waste bin is cleaned.
Check before cleaning TO BE CLEANED Label and after cleaning CLEANED label updated
Check and ensure that all the employees of the respective area are in proper gowning.
Check weights of the tablets and verify in the respective product BMR.
Check and ensure fill all logbook and updated status board
After ensuring the above check points and other points (if any) as per the respective product BMR, the IPQA
Chemist/ Officer shall give the line clearance for the coating Area.
11. Check and ensure all required raw materials are available in the liquid oral day store as per the RM
requisition sheet. Check material and documents of the previous batch/ product are removed.
Check the cleanliness of the manufacturing area.
Check and ensure that the return air filter of the AHU is clean and fitted properly.
Check and ensure the identification of the area and equipment with status labels.
Check the type of cleaning
A type cleaning = Batch to Batch
B type cleaning = Product to Product
Check after continue five batch and hold area 72 hour after B type cleaning
Check and ensure the availability of the cleaned and intact nylon cloth, filter pads and screens of required
measures are available.
Check and ensure fill all logbook and updated status board
Check and ensure suitable poly bags and containers are available in clean and dry condition.
Check and ensure waste bin is cleaned.
Check and ensure employees of the respective area are in proper gowning. Check and ensure that the
temperature, and relative humidity of the compression room is within the limits. The temperature should be
NMT 25 °C. Relative Humidity should be 50 ± 5 %.
Check and ensure weighing balance(s) of day store is qualified.
Check before cleaning TO BE CLEANED Label and after cleaning CLEANED label updated
Check weights of the raw materials and verify in the respective product BMR.
After ensuring the above check points and other points (if any) as per the respective product, the IPQA
Chemist/ Officer shall give the line clearance for the granulation area
12. Line Clearance for Tablet packing/ Capsule
Packing Liquid Oral Packing/Ointment & Dry
Syrup Packing
Check material documents and stereos of the previous batch/ product are removed from the packing area.
Check the cleanliness of the packing area.
Check all the equipment’s of the packing area are clean.
Check the type of cleaning
A type cleaning = Batch to Batch
B type cleaning = Product to Product
Check after continue five batch and hold area 72 hour after B type cleaning
Check before cleaning TO BE CLEANED Label and after cleaning CLEANED label updated
Check and ensure that the return air filter of the AHU is clean and fitted properly.
Check and ensure the identification of the area and equipment with status labels.
Check and ensure that the tablets/ capsules/Liquid/Dry Syrup/Ointment of the respective batch are released by QC
for packing and bears release labels inside and outside of the container.
Check and ensure that the waste bin is cleaned.
Check and ensure that all the employees of the respective area are in proper gowning.
Check and ensure that the temperature and relative humidity of the coating area rooms is within the limits. The
temperature should be NMT 25 °C. Relative Humidity should be 50 ± 5 %.
Check that all the required packing materials are issued and available at the packing area and the PM requisition is
available.
Check and ensure that the weighing balance(s) of hold area of tablets/ capsules is qualified.
Check weights of the tablets/capsules and verify in the respective product BMR.
Check and ensure that the Leak Test Apparatus of packing area of is calibrated and working properly.
Check and ensure fill all logbook and updated status board
After ensuring the above check points and other points (if any) as per the respective product BPR, the IPQA
Chemist/ Officer shall give the line clearance for the packing area
