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
- Abbreviations and Definitions
- Head Q.A, Head and Head – Production are accountable for compliance of this SOP.
- Accountability:
- Head of Quality Assurance to ensure compliance
- Officer – Production to report any discrepancy in product appearances.
- Officer – Quality Assurance to perform the physical inspection and prepare the report.
- RESPONSIBILITY:
- This SOP applies for 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.
- Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores,
- History:
Date Revision Number Reason for Revision
00 NEW SOP
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 labelling.
- Incorrect coding details on product labeling.
- Gross foreign matter such as metal particles, 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 embeded surface spots | a) Particle embeded inside or on the tablets surface
b) Particle adhered to the surface that cannot be removed |
4 | Chipping | Small fragments removed from edges of 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 | Non uniform 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 use of improper plasticizer |
17 | Foreign odour | Self explanatory |
18 | Picking | 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 | Protrusion on capsule surface |
21 | Wrinkles | Self explanatory |
22 | Short capsules | Length of capsule is 1 mm shorter than 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | |
1 | Incorrect product. | 1 | Embedded surface spots of contamination | 1 | Adhering surface spots | ||||
2 | Presence of more than one product (mix-up). | 2 | Broken tablets, cracks or fragments.
|
2 | Picking | ||||
3 | Incorrect colour. | 3 | Capping/ lamination /Mottling/Sticking | 3 | Chips | ||||
4 | Incorrect shape. | 4 | Presence of foreign matter | 4 | Surface not smooth | ||||
5 | Incorrect size (thickness or length) or imprint or embossing. | 5 | Crack or porous surface. | 5 | Poor embossing (shallow, broken) | ||||
6 | Gross foreign matter such as metal particles, glass. | 6 | Excess surface powder | 6 | Projected edges. | ||||
7 | Incorrect labeling | 7 | Tablet with illegible or missing embossing. | 7 | 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | |
1 | Incorrect product. | 1 | Core Tablet not fully coated contamination | 1 | Adhering surface spots | ||||
2 | Presence of more than one (mix-up) | 2 | Broken tablets, cracks or fragments.
|
2 | Picking | ||||
3 | Incorrect colour. | 3 | Capping/ lamination /Mottling. | 3 | Surface blemishes (pits, pimples etc.,) | ||||
4 | Incorrect shape. | 4 | Presence of black particles | 4 | Chips | ||||
5 | Incorrect size (thickness or length) or imprint or embossing. | 5 | Film peeling off/ Coating eruption | 5 | Poor embossing (shallow, broken) | ||||
6 | Gross foreign matter such as metal particles, glass. | 6 | Foreign particle contamination | 6 | Projected edges. | ||||
7 | Incorrect labeling | 7 | Cluster (group of tablets) | 7 | 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | |
1 | Incorrect product
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1 | Empty capsules.
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1 | Pits or dents
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2 | Presence of more than one product (mix-up)
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2 | Stickiness, cracks, breaks, pinholes or splits where leakage of contents may occur.
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2 | Capsule not free of specks or spots
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3 | Incorrect colour.
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3 | Body and or cap of capsule not as specified (length, imprint).
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3 | Capsule not free of cap and/or body cutting into one another. | ||||
4 | Incorrect shape.
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4 | Non uniform in color(s) / appearance.
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4 | Surface not smooth
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5 | Incorrect size (thickness or length) and/or imprint | 5 | Bad joining/Bubbles/Wrinkles
Illegible imprint/Short capsules |
5 | Adhering surface spots
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6 | Foreign matter
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6 | Embedded surface spots or contamination.
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6 | Capsule not free of powder
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7 | Incorrect labeling. | 7 | Double shell, loose closure, over sized.
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7 | Poor print (broken, heavy, smeared, light, off centre, multiple).
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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 DECORTONING OF GLASS VIALS DURING VISUAL INSPECTION
Product Name: Batch Number: Batch Size:
Total Number of Units for Inspection:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | |
1 | Manufacturing defects : Flat Surface of the seal surface is not perpendicular to axis of the body | 1 | Mould defects | 1 | Embedded Particle | ||||
2 | Breakages :Actual pieces of glass broken out of it | 2 | The vials that are not fully blown up or may have sunken | 2 | Air Bubbles | ||||
3 | Cracks :crack appear on the glass wall | 3 | Black spots :black spots appear on transparent glass wall | 3 | 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | |
1 | Mould Defect : Concave or Convex surface | 1 | Broken Flip off seal | 1 | Scratches on external surface of vial | ||||
2 | Black Particle inside the vials | 2 | Black particles | 2 | Improper/Wrinkled crimping. | ||||
3 | No flip off cover on the seal | 3 | Glass Particles | 3 | Dent on the seal | ||||
4 | Flip off opened. | 4 | Embedded Particles | 4 | Loose Seals | ||||
5 | Visually detectable Fill Weight / Volume variations | 5 | Rogue Seal | 5 | Air Bubble | ||||
6 | Broken / Cracked vials | 6 | Improper Sealing | 6 | 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | |
1 | Incorrect product | 1 | Deformed glass vial | 1 | Air Bubble | ||||
2 | Presence of more than one product (mix-up) | 2 | Rogue Label | 2 | Dent on Seal | ||||
3 | Gross foreign matter such as metal particles, glass. | 3 | Torn or Cut label | 3 | Wrinkled Crimping | ||||
4 | Incorrect color | 4 | Smudged Printing | 4 | Misalignment | ||||
5 | In Correct Coding | 5 | Rogue Seal | 5 | Loose Seal | ||||
6 | Improper Sealing | 6 | Embedded Particles | 6 | 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major) | No. of units observed | S.No | Defect (Minor) | No. of units observed | ||
1 | Incorrect product. | 1 | Incorrect Qty | 1 | Final shipper weight is out of limit. | |||||
2 | Presence of more than one (mix-up) | 2 | Undesired marks , hair or spots appearing on primary container on the outside / inside surface | 2 | Absence of Leaflet / cotton/ desiccant in a container | |||||
3 | Incorrect colour. | 3 | Illegible coding of batch details | 3 | Improper bottom lock/reverse tuck in | |||||
4 | Incorrect shape. | 4 | Loose over sized closure | 4 | Loose / slanted, crimpled/stained label. | |||||
5 | Incorrect size (thickness or length) or imprint or embossing. | 5 | Improper Sealing | 5 | Adhering surface spots on final pack containers. | |||||
6 | Incorrect coding details on product | 6 | Foreign particle contamination | 6 | Incorrect coding details on shipper | |||||
7 | Incorrect labeling | 7 | Other if any | 7 | 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:
S.No | Defect (Critical) | No. of units observed | S.No | Defect (Major ) | No. of units observed | S.No | Defect (Minor) | No. of units observed | ||
1 | Incorrect product. | 1 | Incorrect Qty | 1 | Wt of final shipper is out of limit | |||||
2 | Presence of more than one (mix-up) | 2 | Undesired marks , hair or spots appearing on primary container on the outside / inside surface | 2 | Absence of Leaflet in a container | |||||
3 | Incorrect colour/ Incorrect labeling | 3 | Illegible coding of batch details | 3 | Improper bottom lock/reverse tuck in | |||||
4 | Incorrect shape/ Size /Wrong AR. No of bottle used | 4 | Incorrect coding details on product | 4 | Loose / slanted, crimpled/stained label | |||||
5 | Incorrect size (thickness or length) or imprint or embossing. | 5 | Improper Sealing | 5 | Adhering surface spots on final pack containers | |||||
6 | Incorrect coding details on product | 6 | Foreign particle contamination | 6 | Incorrect coding details on shipper | |||||
7 | Lump formation | 7 | Other if any | 7 | 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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