Standard Operating Procedure (SOP) and Guideline for the classification of different types of Quality defects that may be encountered in Tablets/Capsules and the Acceptance Quality Limits (AQL) for the same.
Acceptable Quality Limit (AQL)
1.0 Objective :
- To lay down a procedure for the classification of different types of Quality defects that may be encountered in Tablets/Capsules and the Acceptance Quality Limits (AQL) for the same.
2.0 Scope :
- This SOP is applicable to Tablets / Capsule manufactured at Pharmaceutical drug manufacturing unit.
3.0 Responsibility :
- In process Quality Assurance (IPQA): –
- Recognize the different types of defects and their classification.
- Derive whether the product meets the AQL specification.
- Head Quality assurance:
- Investigate reported deviations and decide on immediate action.
4.0 Procedure – Acceptable Quality Limit (AQL) Procedure & Chart
- Inspect the tablets / capsules (bulk) after final processing step for AQL inspection.
- In-process QA personnel shall take samples from containers as per Annexure-I.
- In-case of coated tablets; carry out inspection of each lot satisfactory.
- In case of uncoated tablets and capsules representative sample of entire batch shall be checked for inspection, if the representative sample quantity is not sufficient for AQL inspection, additional representative sample quantity to be drawn from each product containers.
- If the product container are more than 10 numbers √n+ 1 container to be sampled.
- AQL Inspection shall be done in respective cubical at final stage & sample shall be subjected to visual inspection. Sample shall be taken in polythene lined SS tray for visual inspection of tablet & capsule.
- Classify defects as critical, major, and minor as per the list given in Annexure-II.
- Any other defects which are not listed in the Annexure –II shall also be reported to Head –QA. Head –QA will decide how to classify the defect based on the nature of defect.
- To derive the acceptable levels, ANSI Z1.4, 2003, Single normal procedure to be adopted. Refer Annexure-I.
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Critical defects are such that they:
- Constitute a potential hazard to the user.
- Will result in non-compliance with legal requirements.
- Will seriously reduce the efficiency of the packing machine.
-
Major defects are such that they:
- Are aesthetically undesirable from a customer point of view and will give rise to customer complaint.
- Are functionally undesirable from a customer viewpoint and will give rise to customer complaint.
- Will give rise to problems during the packaging operation and in consequence reduce the efficiency of the operation.
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Minor defects are such that they:
- Are aesthetically undesirable but are not likely to result in customer complaint.
- Are functionally undesirable but are not likely to result the customer complaint.
- Should not cause problems during the packing operations.
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Critical defects (AQL 0.01%):
- If one or more critical defect is observed, the entire batch will be re-inspected.
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Major defects (AQL 0.25%):
- If more than the acceptable number of major defects found, batch should be inspected again.
-
Minor defects (AQL 4.0%):
- If more than the acceptable number of minor defects found, batch should be inspected again.
- When AQL inspection fails to meet the acceptance limits, batch should be inspected by production.
- Again AQL of re-inspection batch shall be done & if the AQL does not meet the acceptance criteria then SOP for “Deviation Control” shall be followed for further action.
- Refer Annexure-I for sample sizes and acceptance limits.
- Record AQL Inspection in Annexure-III.
- The defects classification (Annexure-II) is not an exhaustive list.
- Any new defect will be classified and added to this list.
- QA should be consulted if in doubt of a particular defect classification.
- If the number of defects per sample is less than acceptance number, the batch / lot shall be released for packing.
5.0 Reference :
- Quality Standard: ANSI/ASQZ1.4-2003
7.0 Glossary – Acceptable Quality Limit (AQL)
| SOP | : | Standard Operating Procedure |
| Q.A. | : | Quality Assurance |
| IPQA | : | In process quality assurance |
| AQL | : | Acceptance Quality Limits |
8.0 Annexure – Acceptable Quality Limit (AQL)
Annexure – I : Sample size and acceptance Criteria for tablet / Capsule inspection
Chart : AQL Inspection-Sample size and Acceptance Limits
| Batch Size (Units)* | Sample Size * | 0.01%* | 0.25%* | 4.0%* | |||
| Accept | Reject | Accept | Reject | Accept | Reject | ||
| Up to 35,000 | 500 | 0 | 1 | 3 | 4 | 21 | 22 |
| 35,001 to 150,000 | 800 | 0 | 1 | 5 | 6 | 21 | 22 |
| 150,001 to 500,000 | 1250 | 0 | 1 | 7 | 8 | 21 | 22 |
| 500,001 and above | 2000 | 0 | 1 | 10 | 11 | 21 | 22 |
* Reference: ANSI/ASQ Z1.4-2003, Single normal procedure, Table-II, General level-III
Note: Accept: No. of maximum allowed to pass the AQL criteria
Reject: No. of maximum defective sample to allowed to fails the AQL criteria
Annexure – II : Classification of tablet / Capsule defects.
| CRITICAL | MAJOR | MINOR |
| Uncoated Tablets: | ||
| – Incorrect debossing / color – Non uniform size/ shape – Foreign particulate matter – Capped tablets – Missing Imprints – Layer Separation – Broken tablets – Chipping – Sticking | – Mottled tablets – Layer Mixing – Soft tablets | – Spots – Pitting |
| Coated Tablets: | ||
| – Incorrect Color / imprint – Foreign tablet – Broken tablet – Illegible imprints – Non uniform size / shape – Coated chips – Sticky tablets | – Core exposed – Mottled coating color – Tablets not polished – Obscure imprints | – Spots – Tablet not smooth – Surface blemishes – Coated tablets pitted – Smudged imprints |
| Capsule: | ||
| – Higher weight / Lower weight – Empty capsule – Foreign particle / Black particle – Foreign Capsule – Wrong printing | – Telescopic defects – Denting – Misprinting / Printing Problem – Open Cap body – Double Capping – Broken Capsule – Improper lock length – V notch/notch | – Colour Variation – Shade Variation – Reverse -Printing/smudging |
Annexure – III : AQL Inspection record.
| Product Name | |
| Batch No. | |
| Manufacturing Date | |
| Expiry Date | |
| Batch Size |
Sampling for Inspection – AQL Inspection
| Date | Lot No. | Lot Size | Sample Size | No. of Defects | Nature of Defects | Done By (QA) | Remarks | ||
| Critical | Major | Minor | |||||||
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