In-process Quality Control Procedure : Pharmaceutical Guidelines

In-process Quality Control Procedure

Procedure for in process quality control in manufacturing of liquid and tablet. Checklist for all activities to be done during manufacturing of pharmaceutical products.

A. In-process Activities in Liquid Manufacturing

1. Volume: Check the volume of all filling nozzles. The volume withdraws should not be less than labels claim. Volume should be measured at the start of filling & after every two hrs. Use calibrated measuring Cylinder.
2. Clarity of Solution: Clarity should be checked every 2 hrs. In clear liquid. Note down the observation.
3. Vacuum Leak Test & Test Seal Integrity: Bottles from all sealing heads should be tested for the vacuum leak as per test seal integrity procedure. Screwing & unscrewing to be checked every two hrs. Record the observation.

4. Coding: Coding detail of label & carton is to be checked in the beginning & at frequent intervals besides above type of PP caps. measuring cups, BOPP tapes & quality of bottles in shippers are to be checked prior to the start of the filling/ packing line. Line clearance should be given afrer proper checking of left of previous product / Batch.

B. In-process Activities in Tablet Manufacturing Area

1. Uniformity of Weight (by weight variation): Take the weight of 20 compressed tablet & calculate average weight. Take the individual weight of all 20 tablets & note the minimum wt. & maximum weight of the tablet. The limit for individual table weight variation is up to 80 mg. ± 10% above 80 mg to 250 mg ± 7.5% above 250mg. ± 5% of average weight as per specifications.
2. Disintegration Time: Determine the DT of coated/ uncoated tablets, it should comply with pharmacopoeia / in-house limit.
3. Friability: Carry out friability test as per SOP. The result should comply in house specification limits. Also, measure the thickness. Hardness of the tablets very 2 hrs. & note the result in Q.A Format. The following in process checks should out in tablets.
4. Leak Test of Blister/ Strips: Carry out the test as per SOP all strips blister should pass the leak test.
5. Roller Temperature: Note down & monitor the temp of the blister forming & sealing rollers of the blister strip machine.
6. Over Print Strop: Check th content of overprint on aluminum foil in the beginning & after every two hours.
7. Cutting Quality of Strips: Check that cutting of strips is proper & cutting should not be very near to packet otherwise strip may fail in leak test.
8. Quantity of Strips in Show Box: Check the quality of blister/ strips in the show box randomly it should never be less than printed quantity.

9. Coding Details on Show Box: Check the coding detail of show box. Lic. No. MFG date. EXP. Date & Retail price & manufacturing licence No.
10. Packing Inserts (if any): See that inserts are present in the show box along with strip whereever required.
11. Fill Quantity of Show Box in Shipper: Check that the quantity of show box is not less than mentioned on shipper label.
12. Coding Details on Shipper: Check that coding detail are correctly mentioned and record all the above in process checks on the formats.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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