Standard Operating Procedure of In-process Checks During the Manufacturing of all Products in Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. To establish a procedure for the In-process checks during the manufacturing of all products.
2. Scope:
2.1. It is applicable to all the products being manufactured or Packed at Pharmaceuticals
3. Responsibilities:
3.1. QA Manager
3.2. QC Officer
3.3. Production Pharmacist
3.4. Q.A Officer
4.0 In-process Checks For Tablets Procedure:
4.8. Diameter:
4.8.1. Measure the side length of the tablet by Vernier caliper ,put the tablet between the jaws of Vernier caliper and note the length of the tab according to the specification, first check the zero setting if there is any loosen then turn the bezel to the set ,0 , point of dial to the pointer.
Frequency: Before Start of Compression
4.9. Thickness:
4.9.1. Measure the thickness of the tablet by Vernier caliper ,put the tablet between the jaws of Vernier caliper and note the thickness of the tab according to the specification, first check the zero setting if there is any loosen then turn the bezel to the set ,0 , point of dial to the pointer.
Frequency: Before Start of Production and after each 30 minutes
4.10. Friability Test:
4.10.2. Ensure that the instrument is clean and free from dust
4.10.3. Weight accurately the tablets
4.10.4. Open the apparatus from one removable side of the drum Transfer the tablet and close the drum tightly.
4.10.5. Switch “ON” the apparatus and count the resolutions as specified in the monogram.
4.10.6. Rotate the drum 100 times and remove the tablets
4.10.7. Remove any loose dust or broken tablets and weigh
4.10.8. Switch “OFF” the instrument when not required
Frequency: Before Start of Production
4.11. Hardness:
4.11.1. Ensure that the instrument is clean and free from any residue of dust and tablet
4.11.2. Particle. Hold the tab in the jaw and nozzle in edgewise position.
4.11.3. Adjust the scale, so that the zero on the scale coincides with the pointer
4.11.4. Turn the screw knob till the tablet breaks. the pressure indicated on the dial is in kilogram per sq.cm.
4.10. Disintegration:
4.10.1. Perform the Disintegration test of the required product as mentioned in the individual monograph and calculate the results accordingly.
Frequency: At Start
4.11. Dissolution:
4.11.1. Perform the Dissolution test of the required product as mentioned in the individual monograph and calculate the results accordingly.
Frequency: At Start
4.12. Average Weight:
4.12.1. Take 20 tablets and weight them, then note the weight of a single tablet according to the specification
Frequency: At Start and after each 30 minutes
4.13. Weight Variation:
4.13.1. According to the specification the average weight of the tablets can vary 5 % above or below the average weight.
Frequency: At Start and after each 30 minutes
In-process checks for Capsules:
4.14. Disintegration:
4.14.1. Perform the Disintegration test of the required product as mentioned in the individual monograph and calculate the results accordingly.
Frequency: At Start
4.15. Dissolution:
4.15.1. Perform the Dissolution test of the required product as mentioned in the individual monograph and calculate the results accordingly.
Frequency: At Start
4.16. Average Weight:
4.16.1. Take 20 tablets and weight them, then note the weight of a single tablet according to the specification
Frequency: At Start and after each 30 minutes
4.17. Weight Variation:
4.17.1. According to the specification the average weight of the tablets can vary 5 % above or below the average weight.
Frequency: At Start and after each 30 minutes
4.18. Blister Leakage Test:
4.18.1. Perform the Disintegration test of the required product as mentioned in the individual monograph.
Frequency: At Start
4.18.2. Also Check the B. No. Expiry from BMR.
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