SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects

1
15047

FDA-2

  • ” 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 surfaceb)    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 1 Empty capsules. 1 Pits or dents
2 Presence of more than one product (mix-up) 2 Stickiness, cracks, breaks, pinholes or splits where leakage of contents may occur. 2 Capsule not free of specks or spots
3 Incorrect colour. 3 Body and or cap of capsule not as specified (length, imprint). 3 Capsule not free of cap and/or body cutting into one another.
4 Incorrect shape. 4 Non uniform in color(s) / appearance. 4 Surface not smooth
5 Incorrect size (thickness or length) and/or imprint 5 Bad joining/Bubbles/WrinklesIllegible imprint/Short capsules 5 Adhering surface spots
6 Foreign matter 6 Embedded surface spots or contamination. 6 Capsule not free of powder
7 Incorrect labeling. 7 Double shell, loose closure, over sized. 7 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 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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