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.





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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