Sr. No. |
Test Parameters |
Sample Quantity |
Procedure |
Sample Frequency |
1. |
Appearance /Description for
tablets |
5 tablets from each
batch |
Check for defects like surface finish,
lamination, mottling, chipping and swelling powder on the tablets embossing
(if any), picking, capping and sticking. The appearance of the tablets should
comply with that mentioned in the individual specification. |
Initial, every 2
hours and at the end of the batch. |
2. |
Appearance / Description for capsules |
20 capsules |
Take about 20 capsules at random check for defects
like dented capsules, telescopic capsules, empty capsules, capsules with
notch, printing quality, crust / lump formation in the blend, improper colour
distribution of the blend, powder leaking from the locking end and powder on
capsules. The appearance of the capsules should comply with that mentioned in
the individual Specification. |
Initial, every 2 hours and at the end
of the batch |
3. |
Appearance /
Description for dry syrup |
1 bottle |
Examine for lump formation, caking,
quality of suspension odour. The appearance should comply with that mentioned
in the individual specification. |
Initial, every 2
hours and at the end of the batch |
4. |
Appearance / Description for blend |
Visual inspection of sample collected
for QC analysis |
Examine for colour, lumps formation. The appearance
should comply with that mentioned in the individual specification. |
Final blending or as per specification |
5. |
Disintegration time
testing for tablets |
6 tablets |
Operate the disintegration tester as per SOP. Place 1 dosage unit in each of the
six tubes of the basket and, if prescribed add a disk. Operate the apparatus,
using water or the specified medium as the immersion fluid, and maintain the
temperature at 37±2ºC or given in the specification. At the end of the time
limit specified, lift the basket from the fluid, and observed the tablets.
All of the tablets have disintegrated completely. If 1 or 2 tablets fail to
disintegrate completely, repeat the test on 12 additional tablets. The
requirement is met if not less than 16 of the total of 18 tablets are
disintegrated. The displayed disintegration time shall be reported in terms
of minutes by converting the seconds in to minutes For Example: Suppose the display shows
the time of 4:32 this indicates the disintegration time is 4 minutes and 32
seconds while reporting 32 seconds shall be converted to minutes by dividing
32 by 60. So the reported time shall be 4.53 minutes. |
Initial, every 2
hours and at the end of the batch |
6. |
Disintegration time testing for
capsules |
6 capsules |
Introduce 1 capsule into each tube and operate the
disintegration tester as per the respective SOP. Insert disk over each
capsule. Operate the apparatus, using water or the specified medium as the
immersion fluid, and maintain it at 37±2ºC. At the end of the time
limit, specified Capsules pass the test if all of them
disintegrate completely. Result reporting is the same as for tablets. |
Initial, every 2 hours and at the end of the batch |
7. |
Friability test |
For tablets with a
unit mass equal to or less than 650 mg, take a sample of Whole Tablets
Corresponding to 6.5 g. For Tablets with a Unit mass of More Than 650 mg,
take a sample of 10 Whole Tablets. |
The tablets should be Carefully
de-dusted prior to testing. Accurately weigh the tablets sample, and place
the tablets in the drum. Rotate the drum 100 times, and remove the tablets.
Remove any loose dust from the tablets and accurately weigh them. Operate friability test apparatus as per respective SOP. |
Initial, every 2
hours and at the end of the Batch. |
8. |
Hardness Testing |
6 tablets |
Hardness test shall be performed with the help of
tablet hardness tester as per respective SOP. |
Initial, every 2 hours and at the end
of the batch. |
9. |
Thickness testing
for compressed/ coated tablets |
6 tablets |
Thickness shall be determined using an
vernier caliper/ digital tablet hardness tester as per respective SOP |
Initial, every 2
hours and at the end of compression/ At the end of each coating lot |
10. |
Weight variation (For uncoated tablets) |
1 tablet from each station of the
compression machine |
Weigh individually all tablets, and calculate the
average weight. Using analytical balance as per respective. |
Initial, every 2 hours and at the end
of the batch |
11. |
Weight gain of
coated tablets |
100 tablets |
Take the weight of 100 pre-warmed
tablets and weigh the 100 coated tablets. Calculate the weight gain. |
At the end of each
coating lot |
12. |
Weight variation (For capsules) |
20 capsules |
Weigh 20 intact capsules individually and determine
the average weight. Remove the contents of each capsule with the aid of
a small brush or plug of cotton. Weigh the emptied shells individually and
calculate for each capsule the net weight of its content by subtracting the
weight of the shell from the respective gross weight, and determining the
average net content from the sum of the individual net weights. |
Initial, every 2 hours and at the end
of the Batch. |
13. |
Lock length of the
capsules |
6 capsules |
Lock length of the capsules shall be
determined using a vernier caliper as per respective SOP. |
Initial, every 2
hours and at the end of the batch |
14. |
Loss on drying (Powders / Granules) |
Approximately 2 g or as per
specification |
Determine the loss on drying with the help of IR
moisture analyzer as per SOP
on Operation of Moisture Analyzer |
End of drying or as per the
specification |
15. |
Fill weight of dry
syrups |
No. of bottles
filled while single rotation of dosing wheel |
Take Bottles directly from the dry
syrup filling machine and check the fill weight of powder. |
Initial, every 2
hours and at the end of the batch |
16. |
Leak Test |
Strips from 1 rotation of CSR/ Blisters from sealing plate sealed per stroke/2 bottles (in case of induction sealing)/ Bottles equal to no. of sealing head. |
A leak test shall be performed as per the respective SOP. |
Initially and every 2 hours. |
17. |
Non-Fill Detection |
One tablet/ capsule
from each position of sensor track |
Remove one tablet/ capsule each from
the pockets from each position of the sensor track. Check the blisters
whether they are rejected |
Initial and After
every 2 hrs. |
18. |
Overprinting details |
Random sampling |
Visually check the blister, strips, carton, label
for batch details, wrinkles, proper pasting, appearance, etc. |
Initial and every two hour |
19. |
Bottle / Jar
Cleanliness |
Two bottles/Jar |
Visually check the bottles/Jar for
their cleanliness |
Initial and every 2
hrs. |
20. |
Tablet Count |
Random sampling |
Visually check the counts of the tablets as per the
pack size mentioned in the BPR. |
Initial and every 2 hrs. |
21. |
Desiccant insertion |
Two Jars |
Visually check the number of the
desiccants and insertion of as mentioned in the BPR. |
Initial and every 2
hrs. |
22. |
Induction sealing |
Two bottles/jars |
Visually check for the induction sealing and ensure
that it is okay. |
Initial and every 2 hrs. |
23. |
Labeling |
Random sampling |
Visually check the labeling for any
defects like Wrinkles /crumpled/ slanted/ stained or any other abnormal
observations. |
Initial and every 2
hrs. |
24. |
Leaflet Placement |
Two bottles/jars |
Visually check whether the leaflet is placed
correctly on the bottle cap/ inside the cartons. (as applicable) |
Initial and every 2 hrs. |
25. |
Measuring Cup
Placement |
Two bottles |
Visually check whether the Measuring
Cup is placed correctly on the bottle. |
Initial and every 2
hrs. |
26. |
Tests to be conducted during blister
and strip packing |
Random sampling |
Visually check for any punctures, empty pocket,
overprinting details, sealing quality, knurling quality, forming quality,
sealing and forming plate and roller temperature. |
Initial and every 2 hrs. |
27. |
Carton packing |
Random sampling |
Visually check for the correct coding,
Product details, and weight of the Carton. |
Initial and every 2
hrs |
28. |
Tests to be conducted during shipper
packing |
Random sampling |
Visually check for the correct coding, a number of
unit packed, proper BOPP taping, shipper number, and weight of the shipper. |
Initial, every 2 hrs and at the end of
the batch. |
29. |
Wad sensor for
Induction caps |
1 bottle and cap |
Remove the aluminum wad of the cap mark
it and pass the Bottle and cap through the wad sensor. Check the bottle
whether it is rejected. |
Initial |
30. |
Metal detector challenge test |
Ferrous non-ferrous and S.S. blocks. |
Pass ferrous non-ferrous and S.S. blocks through a
metal detector. Check the blocks whether it is rejected. |
initial |
31. |
Uniformity of
Dispersion |
Two tablets |
Place two tablets in 100ml of water and stir gently until completely dispersed. A smooth dispersion is obtained which passes through a sieve screen with a nominal mesh aperture of 710μm (sieve no.22). |
Initial and every 2
hrs |
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