Defect clasification

1. Defect Classification
• PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur

2. Defect Classification
WHAT IS A DEFECT
 Imperfection
 Shortcoming
In the-
Quality
Quantity
Potency
Purity Or
Standards
Which is required to be maintained
-Undesirable characteristics of a product due to its failure
in conforming to the standard set of specification.

3. WHAT IS A DEFICIENCY ?
 Fault
 Imperfection
 Shortcoming Or
 Inadequacy
In the-
Quality
Standard and
Manner of performance
Which is required to be maintained by or under any
law for the time being in force

4. 1. According to its MEASURABILITY
a. Variable defect –can be measured by instruments
- length, weight, height, thickness, concentration
volume, viscosity, pH
b. Attributive defect– can be measured directly by inspection
- detects odor, and visual examinations like color,
clarity, cleanliness, smoothness, taste
and presence or absence of a characteristics.

5. 2. According to SERIOUSNESS OR GRAVITY
a. Critical defect – endanger life or property & may render the
product non-functional.
- absence of warning in label, disintegration time
of an analgesic
b. Major defect – affect the function of the product and render the
preparation useless.
- crack in the bottle, caking of an emulsion
c. Minor defect – does not endanger life nor affect the function of the
product.
- discoloration of the label or box

6. 3. According to NATURE
a. Ocular defect – a visible defect
- foreign particles contamination
b. Internal defect – a defect that is not seen
- a sub-potent drug product
c. Performance defect – a defect in function
- suppository that does not melt at body
temperature

7.  PQS- Pharmaceutical Quality System Vs GMP
Compliance
MHRA groupings of Deficiency-
1. Quality Management
2. Production
3. Material Management
4. Premises and Equipment
5. Quality Control
6. Validation
7. Regulatory Compliance
8. Personnel

9. Root Cause of
PQS deficiency