SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects.
” Product Inspection for Physical defects ” shall be filed in the Batch Production Record of the respective drug product
In case the incidence of recurrence of a particular defect is frequent , for consecutive batches, Officer – QA shall notify the same to Head – QA for a detailed investigation.
Officer – QA shall affix ‘ HOLD STATUS ‘ label on all containers for inspection.
After 100% inspection the batch/lot shall be rechecked for physical defects.
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.
c) Minor defects :3.0%
b) Major defects :1.0%
a) Critical defects :0%
The Acceptable Quality Limits(AQL’s) for type of defects shall be as follows:
The observed defects shall be entered in the individual formats for Product Inspection for physical defects of core tablets (Annexure – III), coated tablets (Annexure-IV) filled capsules (Annexure-V) and during packing (Annexure -VI) respectively.
Officer – QA shall check and determine the acceptability of the portion sampled based on the percentage of defects.
Officer – 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.
Officer – QA shall compare the defects observed with the defects outlined in the ” List of Possible defects with type classification “(Annexure – I) and for their definitions in Annexure – II.
Any deviation observed by Production personnel with respect to physical appearance shall be immediately referred to the Officer-QA.
In-process inspection shall be performed by Officer – QA at different manufacturing stages.
PROCEDURE
AQL: Acceptable Quality Level
RESPONSIBILITY:
This SOP applies to the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation,coating and packing section of pharmaceutical plant.
Scope:
To lay down the procedure for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation,coating and packing.
OBJECTIVE :
Forms and Records (Annexures)
List of Possible Defects with Type Classification – Annexure – I.
Definitions of terms – Annexure – II.
Product Inspection for Physical Defects of core tablets – Annexure – III.
Product Inspection for Physical Defects of coated tablets – Annexure – IV.
Product Inspection for Physical Defects of filled capsules – Annexure – V.
Product Inspection for Physical Defects of decortoning of glass vials – Annexure – VI
Product Inspection for Physical Defects during optical inspection of filled and sealed vials- Annexure – VII
Product Inspection for Physical Defects during packing of dry powder injection- Annexure – VIII
Product Inspection for Physical Defects During Packing – Annexure – IX
Product Inspection for Physical Defects during Dry Syrup- Annexure – X.
List of Possible Defects with Type Classification – Annexure – I
CRITICAL DEFECTS
- Non-uniform color (Mottling).
- Sticking.
- Tablet with illegible or missing embossing.
- Foreign odour
- Excess surface powder
- Crack or porous surface.
- Presence of foreign matter
- Capping/ lamination.
- Broken tablets,cracks or fragments.
- Embedded surface spots of contamination.
Major defects:
CORE TABLETS
- Incorrect labeling.
- Incorrect coding details on product labeling.
- Gross foreign matter such as metal particles, and glass.
- Fading or change of colour at time of release (for light-sensitive products)
- Incorrect size (thickness or length) and/or imprint or embossing.
- Incorrect shape.
- Incorrect colour.
- Presence of more than one product (mix-up).
- Incorrect product.
COATED TABLETS
- Projected edges.
- Poor embossing (shallow, broken)
- Surface not smooth(e)
- Chips
- Picking
- Adhering surface spots
Minor defects:
Major defects :
- Core tablet not fully coated
- Coating not uniform in color (Mottled).
- Broken tablets
- Cracks or porous surface
- Embedded surface spots or contamination
- Capping
- Foreign particle contamination (Foreign matter)
- Film peeling off
- Foreign odour
- Illegible embossing
- Coating eruption
- Clusters (group of tablets)
Minor Defects :
- Adhering surface spots
- Picking
- Surface not smooth
- Surface blemishes (i.e, Pits, Pimples, etc.)
- Chips
FILLED CAPSULES
Major defects :
- Empty capsules.
- Stickiness, cracks, breaks, pinholes or splits where leakage of contents may occur.
- Body and or cap of capsule not as specified (length, imprint).
- Non uniform in color(s) / appearance.
- Embedded surface spots or contamination.
- Any foreign matter
- Double shell ,loose closure, over sized.
- Bad joining
- Bubbles
- Wrinkles
- Illegible imprint
- Short capsules
Minor Defects :
- Pits or dents
- Capsule not free of specks or spots
- Capsule not free of cap and/or body cutting into one another.
- Surface not smooth
- Adhering surface spots
- Capsule not free of powder
- Poor print (broken, heavy, smeared, light, off centre,multiple).
- Ink marks (spots, smears).
Packaging :
Major defects :
- Incorrect count filled into containers(ii)
- Improper sealing of HDPE containers
- Illegible coding of batch details
- Undesired marks , hair or spots appearing on the primary container on the outside / inside surface
Minor defects
- Adhering surface spots on closures / containers
- Loose / slanted, crimpled/stained label
- Absence of cotton/ dessicant in a container
Definitions of terms – Annexure – II
| S. No | Terminology | Definitions |
| 1 | Form Uniformity | Self-explanatory |
| 2 | Size Uniformity | Self-explanatory |
| 3 | Specks on the surface or embedded surface spots | a) Particle embedded inside or on the tablet surface
b) Particle adhered to the surface that cannot be removed |
| 4 | Chipping | Small fragments were removed from the edges of the tablet. |
| 5 | Capping | The partial or complete separation of the top or bottom crowns of a tablet from the main body of the tablet |
| 6 | Lamination | Lamination is the separation of a tablet into two or more distinct layers |
| 7 | Sticking | Refers to tablet material adhering to the die wall. |
| 8 | Dust/excess surface powder | Powder/ dust adhering to the surface.
|
| 9 | Fading or nonuniform Colour | Irregular color caused by poor distribution of color in the granulation or coating solution |
| 10 | Crack | Self-explanatory |
| 11 | Break | Self-explanatory |
| 12 | Porous surface | Rough surface. |
| 13 | Poor embossing | Illegible embossing or difficult to read. |
| 14 | Color variation | Nonuniform color distribution |
| 15 | Cluster | Group of tablets due to excessive wetting during coating. |
| 16 | Coating eruption | Eruptions on the coated surface due to improper drying or due to the use of improper plasticizer |
| 17 | Foreign odour | Self-explanatory |
| 18 | Picking | A term used to describe the surface material from a tablet that is sticking to and being removed from the tablet surface by a punch |
| 19 | Surface blemishes (Pit, pimples, etc,.) | Rough or irregular surface due to improper coating. |
| 20 | Bubbles | The protrusion on the capsule surface |
| 21 | Wrinkles | Self-explanatory |
| 22 | Short capsules | The length of the capsule is 1 mm shorter than the specified length. |
| 23 | Fragments | Broken edges due to excessive pressure. |
Annexure – III
PRODUCT INSPECTION FOR PHYSICAL DEFECTS OF CORE TABLETS
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Incorrect product. | Embedded surface spots of contamination | Adhering surface spots | ||||
| Presence of more than one product (mix-up). | Broken tablets, cracks or fragments.
|
Picking | ||||
| Incorrect colour. | Capping/ lamination /Mottling/Sticking | Chips | ||||
| Incorrect shape. | Presence of foreign matter | Surface not smooth | ||||
| Incorrect size (thickness or length) or imprint or embossing. | Crack or porous surface. | Poor embossing (shallow, broken) | ||||
| Gross foreign matter such as metal particles, glass. | Excess surface powder | Projected edges. | ||||
| Incorrect labeling | Tablet with illegible or missing embossing. | Other if any | ||||
| Total | Total | Total | ||||
| AQL: 0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – IV
PRODUCT INSPECTION FOR PHYSICAL DEFECTS OF COATED TABLETS
Product Name: Batch Number: Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Incorrect product. | Core Tablet not fully coated contamination | Adhering surface spots | ||||
| Presence of more than one (mix-up) | Broken tablets, cracks or fragments.
|
Picking | ||||
| Incorrect colour. | Capping/ lamination /Mottling. | Surface blemishes (pits, pimples etc.,) | ||||
| Incorrect shape. | Presence of black particles | Chips | ||||
| Incorrect size (thickness or length) or imprint or embossing. | Film peeling off/ Coating eruption | Poor embossing (shallow, broken) | ||||
| Gross foreign matter such as metal particles, glass. | Foreign particle contamination | Projected edges. | ||||
| Incorrect labeling | Cluster (group of tablets) | Other if any | ||||
| Total | Total | Total | ||||
| AQL :0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – V
PRODUCT INSPECTION FOR PHYSICAL DEFECTS OF CAPSULES
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Incorrect product
|
Empty capsules.
|
Pits or dents
|
||||
| Presence of more than one product (mix-up) | Stickiness, cracks, breaks, pinholes or splits where leakage of contents may occur.
|
Capsule not free of specks or spots
|
||||
| Incorrect colour.
|
Body and or cap of capsule not as specified (length, imprint).
|
Capsule not free of cap and/or body cutting into one another. | ||||
| Incorrect shape.
|
Non uniform in color(s) / appearance.
|
Surface not smooth
|
||||
| Incorrect size (thickness or length) and/or imprint | Bad joining/Bubbles/Wrinkles
Illegible imprint/Short capsules |
Adhering surface spots
|
||||
| Foreign matter
|
Embedded surface spots or contamination.
|
Capsule not free of powder
|
||||
| Incorrect labeling. | Double shell, loose closure, over sized.
|
Poor print (broken, heavy, smeared, light, off centre, multiple).
|
||||
| Total | Total | Total | ||||
| AQL: 0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – VI
INSPECTION FOR PHYSICAL DEFECTS OF DECORATING OF GLASS VIALS DURING VISUAL INSPECTION
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Manufacturing defects : Flat Surface of the seal surface is not perpendicular to axis of the body | Mould defects | Embedded Particle | ||||
| Breakages :Actual pieces of glass broken out of it | The vials that are not fully blown up or may have sunken | Air Bubbles | ||||
| Cracks :crack appear on the glass wall | Black spots :black spots appear on transparent glass wall | Other If any | ||||
| Total | Total | Total | ||||
| AQL: 0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – VII
PRODUCT INSPECTION FOR PHYSICAL DEFECTS DURING OPTICAL INSPECTION OF FILLED & SEALED VIALS
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Mould Defect : Concave or Convex surface | Broken Flip off seal | Scratches on external surface of vial | ||||
| Black Particle inside the vials | Black particles | Improper/Wrinkled crimping. | ||||
| No flip off cover on the seal | Glass Particles | Dent on the seal | ||||
| Flip off opened. | Embedded Particles | Loose Seals | ||||
| Visually detectable Fill Weight / Volume variations | Rogue Seal | Air Bubble | ||||
| Broken / Cracked vials | Improper Sealing | Other if any | ||||
| Total | Total | Total | ||||
| AQL: 0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – VIII
PRODUCT INSPECTION FOR PHYSICAL DEFECTS DURING PACKING OF DRY POWDER INJECTION
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Incorrect product | Deformed glass vial | Air Bubble | ||||
| Presence of more than one product (mix-up) | Rogue Label | Dent on Seal | ||||
| Gross foreign matter such as metal particles, glass. | Torn or Cut label | Wrinkled Crimping | ||||
| Incorrect color | Smudged Printing | Misalignment | ||||
| In Correct Coding | Rogue Seal | Loose Seal | ||||
| Improper Sealing | Embedded Particles | Other if any | ||||
| Total | Total | Total | ||||
| AQL :0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – IX
PRODUCT INSPECTION FOR PHYSICAL DEFECTS OF DURING PACKING OF TABLETS/CAPSULE
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major) | No. of units observed | Defect (Minor) | No. of units observed | |
| Incorrect product. | Incorrect Qty | Final shipper weight is out of limit. | ||||
| Presence of more than one (mix-up) | Undesired marks , hair or spots appearing on primary container on the outside / inside surface | Absence of Leaflet / cotton/ desiccant in a container | ||||
| Incorrect colour. | Illegible coding of batch details | Improper bottom lock/reverse tuck in | ||||
| Incorrect shape. | Loose over sized closure | Loose / slanted, crimpled/stained label. | ||||
| Incorrect size (thickness or length) or imprint or embossing. | Improper Sealing | Adhering surface spots on final pack containers. | ||||
| Incorrect coding details on product | Foreign particle contamination | Incorrect coding details on shipper | ||||
| Incorrect labeling | Other if any | Other if any | ||||
| Total | Total | Total | ||||
| AQL: 0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
Annexure – X
PRODUCT INSPECTION FOR PHYSICAL DEFECTS OF DRY SYRUP
Product Name/Batch Number/Batch Size:
Total Number of Units for Inspection:
| Defect (Critical) | No. of units observed | Defect (Major ) | No. of units observed | Defect (Minor) | No. of units observed | |
| Incorrect product. | Incorrect Qty | Wt of final shipper is out of limit | ||||
| Presence of more than one (mix-up) | Undesired marks , hair or spots appearing on primary container on the outside / inside surface | Absence of Leaflet in a container | ||||
| Incorrect colour/ Incorrect labeling | Illegible coding of batch details | Improper bottom lock/reverse tuck in | ||||
| Incorrect shape/ Size /Wrong AR. No of bottle used | Incorrect coding details on product | Loose / slanted, crimpled/stained label | ||||
| Incorrect size (thickness or length) or imprint or embossing. | Improper Sealing | Adhering surface spots on final pack containers | ||||
| Incorrect coding details on product | Foreign particle contamination | Incorrect coding details on shipper | ||||
| Lump formation | Other if any | Other if any | ||||
| Total | Total | Total | ||||
| AQL: 0 % | AQL :1.0 % | AQL :2.5 % | ||||
| Checked by (Sign / Date): | Authorised by (Sign / Date): | |||||
| Batch Status: | Complies / Does Not Comply / Recommended for 100% inspection | |||||
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