SOP for investigation of product for physical defects in tablets

1.0 OBJECTIVE :

To lay down the procedure for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression and coating during investigation of incidents.

2.0 SCOPE :

The scope of this SOP covers procedure for investigation of incidents in case of different types of the physical defects, verification of defects and inspection of defects during manufacturing stages in production department at [company].

3.0 RESPONSIBILITY :

3.1 In process Quality Assurance personnel to perform the physical inspection and prepare the report.

3.2 Production personnel to report any discrepancy in product appearances.

3.3 Head of Quality Assurance to ensure compliance.

4.0 PROCEDURE:

4.1 Whenever any non-conformance observed during in process checks performed for appearance by IPQA or production or any non-conformance reported from QC during analysis regarding appearance following procedure shall be followed:

4.2 IPQA personnel shall perform inspection at different manufacturing stages compression and coating.

4.3 Any deviation observed by Production personnel with respect to physical appearance shall be immediately referred to the QA personnel.

4.4 IPQA personnel shall compare the defects observed with the defects outlined in the “List of Possible defects with type classification “(Annexure – IV) and for their definitions in Annexure – V.

4.5 IPQA personnel shall collect 25 units each, from 4 locations in case of single container. When the number of containers to be sampled is more than one, 100 units from each container shall be pooled for evaluation.

4.6 IPQA personnel shall check and determine the acceptability of the portion sampled based on the percentage of defects.

4.7 The observed defects shall be entered in the individual formats for Product Inspection for physical defects of core tablets (Annexure – I), coated tablets (Annexure-II) .

4.8 The Acceptable Quality Limits (AQL’s) for type of defects shall be as follows:

Critical defects: 0%

Major defects: 1%

Minor defects: 3%

4.9 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 subjected to 100% inspection.

4.10 After 100% inspection the batch/lot by production person the batch / lot shall be rechecked for physical defects by IPQA person.

4.11 During rechecking IPQA personnel shall affix ‘ HOLD STATUS ‘ label (Annexure – III) on all containers for inspection if acceptable quality limit (AQL’s) for the defects found to be more and matter shall be referred to Head QA / Designee by and by production Head / Designee for further action in the matter.

4.12 In case the incidence of recurrence of a particular defect is frequent, for consecutive batches, IPQA personnel shall notify the same to Head – QA for a detailed investigation.

4.13 “Product Inspection for Physical defects” format shall be filed in the Batch Production Record of the respective drug product.

5.0 ANNEXURES

Annexure – I Product Inspection for Physical Defects of core tablets

Annexure – II Product Inspection for Physical Defects of coated tablets

Annexure – III Specimen format of “HOLD STATUS” label

Annexure – IV List of Possible Defects with Type Classification

Annexure – V Definitions of terms

Annexure –I Product inspection for physical defects of core tablets

PRODUCT:

Container No.:

No. of units sampled

for inspection

BATCH NO.:

BATCH SIZE:

Total units for inspection

S. No Critical No. of units observed

1 Incorrect product

2 Presence of more than one product (mix-up)

3 Incorrect color

4 Incorrect shape

5 Incorrect size(thickness/length) and /or imprint or embossing

6 Fading or change of colour at the time of release

7 Gross foreign matter such as metal particles, glass.

8 Incorrect coding details on product labeling

9 Incorrect labeling

10 Others

Total units

Limit: AQL: 0 %

Observed:

Pass/ Fail

S. No. Major No. of units observed

1 Non-uniform color (mottling)

2 Embeded surface spots or contamination

3 Broken tablets, cracks, odd fragments.

4 Capping / Lamination

5 Presence of hair or any other foreign matter

6 Excess surface powder

7 Foreign odour

8 Illegible or missing embossing

9 Cracks /porous surface

10 Sticking

11 Others

Total units

Limit: AQL: 1 %

Observed: Pass/ Fail

S. No. Minor No. of units observed

1 Adhering surface spots, dye spots

2 Picking

3 Chips

4 Surface not smooth

5 Poor embossing (shallow, broken)

6 Projected edges

7 Others

Total units

Limit: AQL: 3 % Observed: Pass/ Fail

Checked by / Date:

Batch status: Conforms/does not conform/Recommended for 100% inspection

Authorized by/ Date (Head – QA / Designee) :

Annexure –II Product inspection for physical defects of coated tablets

PRODUCT :

Container No.:

No. of units sampled for inspection

BATCH NO.:

BATCH SIZE :

Total units for inspection

Details of Defects Observed

S. No Critical No. of units observed

1 Incorrect product

2 Presence of more than one product (mix-up)

3 Incorrect color

4 Incorrect shape

5 Incorrect size(thickness/length) and /or imprint or embossing

6 Fading or change of colour at the time of release

7 Gross foreign matter such as metal particles, glass.

8 Incorrect coding details on product labeling

9 Incorrect labeling

10 Others

Total units

Limit: AQL : 0 %

Observed: Pass/ Fail

S. No. Major No. of units observed

1 Core not fully coated

2 Coating not uniform in color (mottled)

3 Broken tablets

4 Crack, porous surface

5 Embeded surface spots or contamination

6 Capping

7 Foreign particle contamination

8 Film peeling off

9 Foreign odour

10 Illegible embossing

11 Coating eruption

12 Cluster (group of tablets)

13 Others

Total units

Limit: AQL: 1 %

Observed: Pass/ Fail

S.No. Minor No. of units observed

1 Adhering surface spots

2 Picking

3 Surface not smooth

4 Surface blemishes (pits,pimples etc.,)

5 Chips

6 Others Total units

Limit: AQL : 3 %

Observed: Pass/ Fail

Checked by / Date:

Batch status: Conforms/does not conform/Recommended for 100% inspection

Authorised by / Date (Head – QA / Designee):

Annexure – III Specimen format of “HOLD STATUS” label

[Not provided]

Annexure – IV List of Possible Defects with Type Classification

I. CRITICAL DEFECTS

1. Incorrect product.

2. Presence of more than one product (mix-up).

3. Incorrect color.

4. Incorrect shape.

5. Incorrect size (thickness or length) and/or imprint or embossing.

6. Fading or change of color at time of release (for light sensitive products)

7. Gross foreign matter such as metal particles, glass.

8. Incorrect coding details on product labeling.

9. Incorrect labeling.

CORE TABLETS

1. Major defects:

(a) Embedded surface spots of contamination

(b) Broken tablets, cracks or fragments

(d) Presence of foreign matter

(e) Crack or porous surface

(f) Excess surface powder

(g) Foreign odour

(h) Tablet with illegible or missing embossing

(i) Sticking impression

(j) Non-uniform color (Mottling).

1. Minor defects:

(a) Adhering surface spots

(b) Picking

(d) Surface not smooth

(e) Poor embossing (shallow, broken)

(f) Projected edges.

COATED TABLETS

1. Major defects:

(a) Core tablet not fully coated

(b) Coating not uniform in color (Mottled).

(d) Cracks or porous surface

(e) Embedded surface spots or contamination.

(f) Capping

(g) Foreign particle contamination (Foreign matter).

(h) Film peeling off

(i) Foreign odour

(j) Illegible embossing

(k) Coating eruption

(l) Clusters (group of tablets).

2. Minor Defects:

(a) Adhering surface spots

(b) Picking

(d) Surface blemishes (i.e., Pits, Pimples, etc.)

(e) Chips

Annexure – V Definitions of terms

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 color	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.