This document presents a case study on corrective and preventive action (CAPA) for tablet defects. It describes a problem where tablets were separating into layers during manufacturing. The defect was identified as lamination, caused by over-dried granules lacking cohesion. To address this, corrective action involved adding hygroscopic materials to maintain moisture levels. Preventive actions included improved training, self-inspections, process validation and revised standard operating procedures to prevent future lamination issues.

1. Case Study on CAPA for Tablet
Defects
Presented by
Ch. S S N D Balakrishna, M.Pharm
Roll no: 219303
Department of Regulatory Affairs
Shri Vishnu College of Pharmacy (SVCP)

2. Introduction
Corrective and preventive action consists of improvements to an
organization's processes taken to eliminate causes of non-conformities or other
undesirable situations.
It is usually a set of actions that takes place in manufacturing,
documentation, procedures, or systems to rectify and eliminate recurring non-
conformance.

3. Steps involved in CAPA
 Identification
 Evaluation
 Investigation
 Analysis
 Action plan
 Action implementation
 Follow-up

4. An ideal tablet should be free from any visual defect or
functional defect. Defects in tablet are related to
imperfections in any one or more of the following factors
Tableting Process Formulation Machine

5. lamination
capping
cracking
sticking
picking
chipping
binding
Double
impression
mottling
Tablet
defects

6. Case Study
Problem:
A leading pharmaceutical firm was in the process of
manufacturing a batch of tablets. Initial tests during
scaleup showed a separation of tablets into two or
more layers. Due to this problem a batch of tablets
were rejected.

7. Identification
After identifying the problem it was found that this problem
is due to the defect of lamination
Lamination:
Lamination is the separation of a tablet into two or more
distinct horizontal layers.
It is very similar to capping, but occurs in the main
body of the tablet, not at the top, and it can occur
immediately after compression or during the storage
period.

8. Difference between lamination and Capping
Lamination:
It is the separation of a tablet into two or more
distinct horizontal layers.
Capping:
It is the term used, when the upper or lower segment
of the tablet separates horizontally during ejection
from the tablet press, or during subsequent handling

9. Root Cause Analysis
After identification of problem, we implemented the root
cause analysis for the problem.
Excessive quantity of dry Granules is an reason of Lamination
which may be due to bad drying. We found that the problem is
occurred because of over dried granules.

10. Formulation related Machine related
Causes Remedies Causes Remedies
Oily or waxy
materials in
granules.
Modify mixing
process. Add
adsorbent or
absorbent
Rapid relaxation of
the peripheral
regions of a tablet,
on ejection from a
die.
Use tapered dies,
i.e. upper part of the
die bore has an
outward taper of 3°
to 5°.
Over dried
granules (Due
to lack of
cohesion)
By maintaining
moisture levels
using hygroscopic
materials
Rapid
decompression
Use pre-
compression step.
Reduce turret speed
and reduce the final
compression
pressure.

11. Corrective Action
By maintaining moisture levels adding hygroscopic
materials like MC (Methyl Cellulose), Sorbitol, PEG 4000
(Polyethylene glycol) etc. maintains the moisture levels in
the tablets and that helps in the prevention of lamination

12. Preventive Action
Implementing proper training plan to the personnel
responsible for formulation.
Implementing self inspection program to evaluate and minimize
the defects.
Process validation
Revising the sops

13. Thank You