REVIEW & GAP ANALYSIS OF PROCESS VALIDATION PROGRAM Case Study 2

Case Study

Batch Numbers 001 to 0037

Processing Time (minutes) Major Impurity (Limit NMT 1.00 %)

REVIEW & GAP ANALYSIS: PROCESS VALIDATION PROGRAM IN THIS CASE STUDY

by Manish Bhatkar

The identified gaps/ deficiencies were

Founder & CEO – RedLotus Pharmtech Pvt. Ltd. systematically rectified by upgrading and/ or
seamlessly integrating the corresponding
Process validation repetitively appeared as a of SOP’s, processes, systems and practices
SOP, process, system, practice.
major cause of concern in various regulatory were superimposed on the desired framework
inspections, like USFDA, MHRA, TGA, to identify gaps/ deficiencies (if any). This complete exercise resulted in improving &
ANVISA, WHO etc. in a large multinational implementing a robust process validation
Following figure shows the desired framework
pharmaceutical company having drug product, program, that stood firm to the rigors of all
for process validation, the text in yellow
biologicals and API manufacturing sites all subsequent regulatory inspections.
explosion indicates existing gaps/ deficiencies
across the world including India, USA, Brazil &
Japan.
To identify and close the gaps in already
existing process validation program applicable
through a central procedure, a detail and
thorough review & gap analysis exercise was
initiated. In this exercise, 3 – point approach as
explained below was followed:
1. Understanding of requirements
2. Development of a standard framework
3. Superimposing the existing framework on
the standard framework
Current requirements on process validation by
all regulatory agencies, commonly observed
deficiencies (internal as well as external)
industry benchmarking and best practices
were studied in detail.
This study finding(s) is then transformed into a
simple framework for an ideal process
validation program, which could meet all
regulator’ expectations and yet easy to follow
in the organization.
Existing controls already implemented and
being in effect in the organization in the form
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