1.0 OBJECTIVE
This classifies the defects obtained in uncoated / coated tablets and filled capsule by visual inspection of samples as per AQL (Acceptable Quality Level) to decide the suitability of the lot/batch for next stage of the process.2.0 SCOPE
Applicable to all compressed / coated tablets and filled capsule being manufactured.3.0 RESPONSIBILITY
QA Executive4.0 ACCOUNTABILITY
5.0 PROCEDURE
5.1 AQL sampling and inspection should be done as per the requirement of product at different stages of manufacturing viz. initial parameter checks of compression, parameter checks during compression and parameter checks after coating, inspection of tablets or after filling/sorting of capsules.5.2 The AQL sampling and ‘accept / reject’ criteria should be decided according to the lot size / batch size and it should be given in respective BMR.
5.3 Samples should be withdrawn from the container or coating pan as per sampling plan.
5.4 If all observations are within limit, the lot/batch can be released for the next stage of process.
5.5 If the observations are not complied, inform to QA management for appropriate disposition or do 100% visual inspection of respective lot / batch in following condition
5.5.1 If the no. of major /minor reject is at higher side.
5.5.2 If the results of AQL does not comply with the accept level.
5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure.
5.7 Rejects of AQL analysis should be disposed as per SOP, while good tablets after AQL inspection should be added in respective lot / batch.
5.8 If the AQL sampling is done in the area other than processing area, good tablets from the AQL samples should be disposed as per SOP.
5.9 INITIAL PARAMETER CHECKS
5.9.1 In initial checks, inspection level should be S-4 with AQL criterion of 0.065, 1.5 & 4.0 for critical, major and minor defects respectively at ‘Normal’ level (Level of severity of inspection) with ‘Single Sampling Plan’.
5.9.2 Depending upon this AQL criteria the sample size & ‘accept / reject’ of defective sample will be set according to lot/batch size, by referring the AQL inspectors rule or as per Annexure - I.
5.9.3 After initial setup, collect the samples of tablets from both the sides of machine (whenever applicable) and inspect visually for the defect as mentioned in point No. 5.10.
5.9.4 Note down the number of defective tablets in the BMR for the respective level and decide for acceptance / rejection of the sample.
Example for referring of AQL chart (available with the departments) for initial checks:
i) Consider that the batch size is 50,000 Nos and select the same in batch or lot size window of AQL chart. For this batch size, select ‘S-4’ as inspection level among seven inspection levels (I, II, III, S1, S2, S3 & S4).
ii) As the batch size and inspection level are fixed, check the sample size code letter in the window of AQL chart, which comes to be ‘J’.
iii) Check the sample size (which comes to be 80) against the code (J) for individual type of reject along with a number of defective samples for acceptance or rejection of AQL which will be as per the following table.
NOTE:
ACCEPT: Number of Maximum defective samples allowed to pass the AQL criteria.
REJECT: Number of Maximum defective samples allowed to fail the AQL criteria.
5.10 Classification of defects should be done as follows:
For Compressed Tablets
5.10.1 In ‘Critical’ defects, check for
5.10.1.1 Incorrect debossing / color
5.10.1.2 Non uniform size/ shape
5.10.1.3 Foreign particulate matter
5.10.1.4 Capped tablets
5.10.1.5 Missing Imprints
5.10.1.6 Soft tablets
5.5.2 If the results of AQL does not comply with the accept level.
5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure.
5.7 Rejects of AQL analysis should be disposed as per SOP, while good tablets after AQL inspection should be added in respective lot / batch.
5.8 If the AQL sampling is done in the area other than processing area, good tablets from the AQL samples should be disposed as per SOP.
5.9 INITIAL PARAMETER CHECKS
5.9.1 In initial checks, inspection level should be S-4 with AQL criterion of 0.065, 1.5 & 4.0 for critical, major and minor defects respectively at ‘Normal’ level (Level of severity of inspection) with ‘Single Sampling Plan’.
5.9.2 Depending upon this AQL criteria the sample size & ‘accept / reject’ of defective sample will be set according to lot/batch size, by referring the AQL inspectors rule or as per Annexure - I.
5.9.3 After initial setup, collect the samples of tablets from both the sides of machine (whenever applicable) and inspect visually for the defect as mentioned in point No. 5.10.
5.9.4 Note down the number of defective tablets in the BMR for the respective level and decide for acceptance / rejection of the sample.
Example for referring of AQL chart (available with the departments) for initial checks:
i) Consider that the batch size is 50,000 Nos and select the same in batch or lot size window of AQL chart. For this batch size, select ‘S-4’ as inspection level among seven inspection levels (I, II, III, S1, S2, S3 & S4).
ii) As the batch size and inspection level are fixed, check the sample size code letter in the window of AQL chart, which comes to be ‘J’.
iii) Check the sample size (which comes to be 80) against the code (J) for individual type of reject along with a number of defective samples for acceptance or rejection of AQL which will be as per the following table.
AQLS
|
SAMPLE SIZE
|
ACCEPT
|
REJECT
|
Critical
0.065
|
80
|
0
|
1
|
Major
1.5
|
3
|
4
|
|
Minor
4.0
|
7
|
8
|
ACCEPT: Number of Maximum defective samples allowed to pass the AQL criteria.
REJECT: Number of Maximum defective samples allowed to fail the AQL criteria.
5.10 Classification of defects should be done as follows:
For Compressed Tablets
5.10.1 In ‘Critical’ defects, check for
5.10.1.1 Incorrect debossing / color
5.10.1.2 Non uniform size/ shape
5.10.1.3 Foreign particulate matter
5.10.1.4 Capped tablets
5.10.1.5 Missing Imprints
5.10.1.6 Soft tablets
5.10.2 In ‘Major’ defects, check for
5.10.2.1 Mottled tablets
5.10.2.2 Broken tablets
5.10.3 In ‘Minor’ defects, check for
5.10.3.1 Spots
5.10.3.2 Chipping
5.10.3.3 Pitting
5.10.3.4 Sticking
5.11 IN PROCESS CHECKS (DURING COMPRESSION)
5.11.1 During in-process checks, inspection level should be ‘I’ with AQL criterion of 0.065, 1.5 & 4.0 for Critical, Major & Minor at ‘Normal level’ (Level of severity of inspection) with ‘Single Sampling Plan’.
5.11.2 During compression run, take the sample for AQL analysis.
5.11.3 Frequency should be decided as per respective BMR considering the machine speed and total operation time of process.
5.11.4 Calculation of quantity of units for in-process sampling should be done as follows :
a
X = ----- x c
b
Where,
X = Number of units
a = Total cumulative samples as per Annexure - II
b = Total production time in min
c = frequency in min
5.11.5 In case of double rotary machine, half quantity of samples to be withdrawn from each side of the machine.
5.11.6 The calculated quantity should be rounded off, towards higher side.
5.11.7 Visually inspect the samples for the defects as mentioned in point No. 5.10.
5.12.1 After coating (for each lot), inspection level should be ‘I’ with AQL criterion of 0.065, 1.5 & 4.0 for critical, Major & Minor at ‘Normal level’ (Level of severity of inspection) with ‘Single Sampling Plan’.
5.12.2 Follow the AQL inspector’s rule as per Annexure - II to decide the sample size and number of tablets to be accepted and rejected.
5.12.3 Note down the number of defective tablets in the BMR for the respective level and decide for acceptance or rejection of the sample.
5.13 Classification of defects in coated tablets should be done as follows:
5.13.1 In ‘Critical’ defects check for
5.13.1.1 Incorrect Color / imprint
5.13.1.2 Foreign tablet
5.13.1.3 Broken tablet
5.13.1.4 Illegible imprints
5.13.2 In ‘Major’ defects check for
5.13.2.1 Core exposed
5.13.2.2 Mottled coating color
5.13.2.3 Non uniform size / shape
5.13.2.4 Coated chips
5.13.2.5 Sticky tablets
5.13.2.6 Tablets not polished
5.13.2.7 Obscure imprints
5.13.3 In ‘Minor’ defects check for
5.13.3.1 Spots
5.13.3.2 Tablet not smooth
5.13.3.3 Surface blemishes
5.13.3.4 Coated tablets pitted
5.13.3.5 Smudged imprints
5.13.3.6 Minor chips
5.14 AFTER FILLING / SORTING OF CAPSULES
5.14.1 After filling (for each lot), inspection level should be ‘I’ with AQL criterion of 0.065, 1.5 & 4.0 for critical, Major & Minor at ‘Normal level’ (Level of severity of inspection) with ‘Single Sampling Plan’.
5.14.2 Follow the AQL inspector’s rule as per Annexure - III to decide the sample size and number of capsules to be accepted and rejected.
5.14.3 Note down the number of defective capsules in the BMR for the respective level and decide for acceptance or rejection of the sample.
5.15 Classification of defects in a filled capsule should be done as follows:
5.15.1 In ‘Critical’ defects check for
5.15.1.1 Higher weight / Lower weight
5.15.1.2 Empty capsule
5.15.1.3 Foreign particle / Black particle
5.15.1.4 Foreign Capsule
5.15.1.5 Wrong printing
5.15.2 Major Defects:
5.15.2.1 Telescopic defects
5.15.2.2 Denting
5.15.2.3 Misprinting / Printing Problem
5.15.2.4 Open Cap body
5.15.2.5 Double Capping
5.15.2.6 Broken Capsule
5.15.2.7 Improper lock length
5.15.2.8 V notch/notch
5.15.3 Minor Defect:
5.15.3.1 Colour Variation
5.15.3.2 Shade Variation
5.15.3.3 Reverse Printing/smudging
5.16 After checking the AQL samples, take appropriate decision for a lot / batch before proceeding to the next step as per instruction 5.5 & 5.6.
6.2 AQL: Acceptable Quality Level
6.3 QA: Quality Assurance
6.4 No.: Number
6.5 Nos.: Numbers
6.6 ANDA: Abbreviated New Drug Application
6.7 BMR: Batch Manufacturing Record
6.8 %: Percentage
6.9 min: Minute
6.10 mins: Minutes
5.10.2.1 Mottled tablets
5.10.2.2 Broken tablets
5.10.3 In ‘Minor’ defects, check for
5.10.3.1 Spots
5.10.3.2 Chipping
5.10.3.3 Pitting
5.10.3.4 Sticking
5.11 IN PROCESS CHECKS (DURING COMPRESSION)
5.11.1 During in-process checks, inspection level should be ‘I’ with AQL criterion of 0.065, 1.5 & 4.0 for Critical, Major & Minor at ‘Normal level’ (Level of severity of inspection) with ‘Single Sampling Plan’.
5.11.2 During compression run, take the sample for AQL analysis.
5.11.3 Frequency should be decided as per respective BMR considering the machine speed and total operation time of process.
5.11.4 Calculation of quantity of units for in-process sampling should be done as follows :
a
X = ----- x c
b
Where,
X = Number of units
a = Total cumulative samples as per Annexure - II
b = Total production time in min
c = frequency in min
5.11.5 In case of double rotary machine, half quantity of samples to be withdrawn from each side of the machine.
5.11.6 The calculated quantity should be rounded off, towards higher side.
5.11.7 Visually inspect the samples for the defects as mentioned in point No. 5.10.
5.12.1 After coating (for each lot), inspection level should be ‘I’ with AQL criterion of 0.065, 1.5 & 4.0 for critical, Major & Minor at ‘Normal level’ (Level of severity of inspection) with ‘Single Sampling Plan’.
5.12.2 Follow the AQL inspector’s rule as per Annexure - II to decide the sample size and number of tablets to be accepted and rejected.
5.12.3 Note down the number of defective tablets in the BMR for the respective level and decide for acceptance or rejection of the sample.
5.13 Classification of defects in coated tablets should be done as follows:
5.13.1 In ‘Critical’ defects check for
5.13.1.1 Incorrect Color / imprint
5.13.1.2 Foreign tablet
5.13.1.3 Broken tablet
5.13.1.4 Illegible imprints
5.13.2 In ‘Major’ defects check for
5.13.2.1 Core exposed
5.13.2.2 Mottled coating color
5.13.2.3 Non uniform size / shape
5.13.2.4 Coated chips
5.13.2.5 Sticky tablets
5.13.2.6 Tablets not polished
5.13.2.7 Obscure imprints
5.13.3 In ‘Minor’ defects check for
5.13.3.1 Spots
5.13.3.2 Tablet not smooth
5.13.3.3 Surface blemishes
5.13.3.4 Coated tablets pitted
5.13.3.5 Smudged imprints
5.13.3.6 Minor chips
5.14 AFTER FILLING / SORTING OF CAPSULES
5.14.1 After filling (for each lot), inspection level should be ‘I’ with AQL criterion of 0.065, 1.5 & 4.0 for critical, Major & Minor at ‘Normal level’ (Level of severity of inspection) with ‘Single Sampling Plan’.
5.14.2 Follow the AQL inspector’s rule as per Annexure - III to decide the sample size and number of capsules to be accepted and rejected.
5.14.3 Note down the number of defective capsules in the BMR for the respective level and decide for acceptance or rejection of the sample.
5.15 Classification of defects in a filled capsule should be done as follows:
5.15.1 In ‘Critical’ defects check for
5.15.1.1 Higher weight / Lower weight
5.15.1.2 Empty capsule
5.15.1.3 Foreign particle / Black particle
5.15.1.4 Foreign Capsule
5.15.1.5 Wrong printing
5.15.2 Major Defects:
5.15.2.1 Telescopic defects
5.15.2.2 Denting
5.15.2.3 Misprinting / Printing Problem
5.15.2.4 Open Cap body
5.15.2.5 Double Capping
5.15.2.6 Broken Capsule
5.15.2.7 Improper lock length
5.15.2.8 V notch/notch
5.15.3 Minor Defect:
5.15.3.1 Colour Variation
5.15.3.2 Shade Variation
5.15.3.3 Reverse Printing/smudging
5.16 After checking the AQL samples, take appropriate decision for a lot / batch before proceeding to the next step as per instruction 5.5 & 5.6.
6.0 ABBREVIATION
6.1 SOP: Standard Operating Procedure6.2 AQL: Acceptable Quality Level
6.3 QA: Quality Assurance
6.4 No.: Number
6.5 Nos.: Numbers
6.6 ANDA: Abbreviated New Drug Application
6.7 BMR: Batch Manufacturing Record
6.8 %: Percentage
6.9 min: Minute
6.10 mins: Minutes
ANNEXURE - I
Following sample size and accept / reject criteria for various batch sizes considering inspection level S-4 This is to be followed for initial checks for compression.
Batch Size
|
3,201 to 10,000 Nos.
|
10,001 to 35,000 Nos.
|
35,001 to 150,000 Nos.
|
150,001 to 500,000 Nos.
|
500,001 Nos. or more
|
|||||
Sample size
|
32 Nos.
|
50 Nos.
|
80 Nos.
|
80 Nos.
|
125 Nos.
|
|||||
AQLS
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Critical 0.065
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
Major 1.5
|
1
|
2
|
2
|
3
|
3
|
4
|
3
|
4
|
5
|
6
|
Minor 4.0
|
3
|
4
|
5
|
6
|
7
|
8
|
7
|
8
|
10
|
11
|
ANNEXURE - II
Following sample size and accept/reject criteria for various batch sizes considering inspection level 1.
This is to be followed for in-process checks during compression and after coating.
This is to be followed for in process checks during and after filled capsule.
This is to be followed for in-process checks during compression and after coating.
Batch Size
|
3,201 to 10,000 Nos.
|
10,001 to 35,000 Nos.
|
35,001 to 150,000 Nos.
|
150,001 to 500,000 Nos.
|
500,001 Nos. or more
|
|||||
Sample size
|
80 Nos.
|
125 Nos.
|
200 Nos.
|
315 Nos.
|
500 Nos.
|
|||||
AQLS
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Critical 0.065
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
1
|
2
|
Major 1.5
|
3
|
4
|
5
|
6
|
7
|
8
|
10
|
11
|
14
|
15
|
Minor 4.0
|
7
|
8
|
10
|
11
|
14
|
15
|
21
|
22
|
21
|
22
|
ANNEXURE -III
Following sample size and accept / reject criteria for various batch sizes considering inspection level 1. This is to be followed for in process checks during and after filled capsule.
Batch Size
|
3,201 to 10,000 Nos.
|
10,001 to 35,000 Nos.
|
35,001 to 150,000 Nos.
|
150,001 to 500,000 Nos.
|
500,001 Nos. or more
|
|||||
Sample size
|
80 Nos.
|
125 Nos.
|
200 Nos.
|
315 Nos.
|
500 Nos.
|
|||||
AQLS
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Accept
|
Reject
|
Critical 0.065
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
1
|
2
|
Major 1.5
|
3
|
4
|
5
|
6
|
7
|
8
|
10
|
11
|
14
|
15
|
Minor 4.0
|
7
|
8
|
10
|
11
|
14
|
15
|
21
|
22
|
21
|
22
|
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