1.0 OBJECTIVE
To lay down the procedure for the visual inspection and statistical evaluation of a batch ( Acceptance Quality Level).
- SCOPE
This procedure is applicable for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation, coating and packing in the company (XXX Name of the company).
3.0 RESPONSIBILITY:
Authorized Designee of QA to perform AQL according the specified procedure
Authorized designee of Production report the discrepancies
Head of Quality Assurance to ensure compliance according to SOP.
4.0 PROCEDURE:
4.1 In-process inspection shall be performed by authorized designee of QA at different manufacturing stages.
4.2 Any deviation observed by Production personnel with respect to physical appearance shall be immediately referred to the authorized designee of QA.
4.3 Authorized designee of QA shall compare the defects observed with the defects mentioned in the “List of Possible defects with type classification and for their definitions in as mentioned in different annexure.
4.4 Authorized designee of QA shall collect 25 units each, from 4 locations at random from each container. When the number of containers to be sampled is more than one, 100 units from each container shall be pooled for evaluation.
4.5 Authorized designee of QA shall check and determine the acceptability of the portion sample based on the percentage of defects.
4.6 The observed defects shall be entered in the individual formats for Product Inspection for physical defects of core tablets, coated tablets, filled capsules and during packing respectively.
4.7 The Acceptable Quality Limits (AQL’s) for type of defects shall be as follows:
a) Critical defects : 0%
b) Major defects : 1.0%
c) Minor defects : 3.0%
4.8 In case physical defects are observed and after evaluation the percentages are found to be more than that specified as AQL, the batch /lot shall be 100% inspected.
4.9 After 100% inspection the batch/lot shall be rechecked for physical defects.
4.10 Authorized designee of QA shall affix ‘ HOLD STATUS ‘ label, on all containers for inspection.
4.11 In case the incidence of recurrence of a particular defect is frequent, for consecutive batches, authorized designee of QA shall notify the same to Head – QA for a detailed investigation.
- ABBREVIATION(s)
| Abbreviation | Full Description |
| AQL | Acceptable Quality Limits |
- ANNEXURE(s)
| Annexure No. | Details/Title of Annexure |
| 1 | List of Possible Defects with Type Classification |
| 2 | Definitions of terms |
| 3 | Format for “Product Inspection for Physical Defects of core tablets” |
| 4 | Format for “Product Inspection for Physical Defects of coated tablets” |
| 5 | Format for “Product Inspection for Physical Defects of filled capsules” |
| 6 | Format for “Product Inspection for Physical Defects During Packing” |