Process Validation

PROCESS
VALIDATION
For Large Volume Parenteral (LVP)

What is Process Validation
Pharmaceutical process validation is the documented
verification that a manufacturing process consistently
produces products meeting predetermined quality
specifications. It Process validation is defined as the
Collection and evaluation of data from the process design
stage through commercial production, which established
scientific evidences that a process is capable of consistently
delivering quality product.
Phases of Process Validation
Stage 1 Stage 2 Stage 3

Process Design Process Qualification Continued Process
Verification
Stage 01
Process Design (Stage 1):
● Manufacturing process is planned and designed
● Quality by Design (QbD) principles
● Defined the critical quality attributes (CQAs) like physical,
chemical, biological, or microbiological characteristics.
(Temperature, pH level, mixing speed, filtration pressure, fill
volume)
● After CQAs, Critical process parameters are (CPPs) are defined.
● (Sterility, Potency, Purity, PH, Particulate Matter, Stability)
Process Design (Stage 1):
● Critical process parameters can impact the critical quality
attributes
● After the CPP have been identified, the manufacturing process is
designed.
● Process design also established the control parameters
● Control parameters include monitoring and testing critical
process parameters to verify the product quality.
● Risk assessments and critical quality attributes (CQAs).
Stage 02
Process Qualification (Stage 2):
● Manufacturing process is validated through series of
qualifications
● Installation Qualification ( for equipment’s which are related to
process )
● Operational Qualification :Manufacturing process is tested to
ensure it consistently produces the drug product within the
defined specifications.
● The final stage of process qualification is performance
qualification (PQ) manufacturing process is tested under actual
production conditions.
Stage 03
Continued Process Verification (Stage 3):
● Process is continuously monitored.
● Routine monitoring of process performance and product quality.
● If any issue detected, corrective actions are taken.
● Process should revalidated.
● It is critical in ensuring that the manufacturing process remains
consistent and reliable over time.
● It helps to ensure that the drug product remains safe and
effective.
Pre- Requisites of Process Validation
● All equipment’s to be used should have been qualified ( IQ,OQ,
PQ )
● The product facility and area should be validated.
● Analytical testing methods to be used should have been fully
validated.
● Critical support systems (Water, Compressed air) should be
validated.
● Raw and packing materials are in approved stage.
● Staff taking part in the validation work should have been
appropriately trained.
Types of Process Validation
01 Prospective Validation 03 Retrospective Validation
02 Concurrent Validation 04 Re- Validation

Prospective Validation
● It is establishing documented evidence prior to process
implementation that a system does what it proposed to do based
on the pre-planned protocol. Under the objective to prove that
the process will work in accordance with a validation protocol.
● An experimental plan called validation protocol is executed
before the process is put into commercial use.
● It is normally undertaken for a new drug product or new
facilities are introduced into a routine pharmaceutical
production.
Prospective Validation
● Carried out during the development stages by means of a risk

analysis of the production process, which is broken down into
individual steps.
● Representing Production, QA, QC, and Engineering person
should involve the validation execution
Prospective Validation Protocol
Consist of :
• Objective, Scope, Responsibilities

• Process flow
• A description of the process
• A description of the experiment
• Details of the equipment’s which is
used
• The Variables to monitor
• Sampling plan
• Acceptance limits, Details of
methods for recording and
evaluating results, including statical
analysis.
• Summary / Conclusion
Concurrent Validation
● Concurrent validation is used to establish documented evidence
that a facility and process will perform as they are intended,
based on information generated during actual use of the
process.
● Validation process is divided into two type depending upon the

testing : In process monitoring and End process testing
● Documented process done as per the prospective validation

protocol.
Retrospective Validation
● It is an establishing documented evidence that a process does
what it is supposed to do based on review and analysis of
historic data.
● As per the Audit observation point or market complaint this type
of process validation is performed.
● During Retrospective validation historical data to provide the
necessary documentary evidence that the process is doing what it
is supposed to do.
● Protocol also contended with the simple steps major step is data
analysis and reviewing then the conclusion and
recommendations will give based on the trend data.
Re- Validation
● Re- Validation provides the evidence that changes in a process
and process environments introduced either intentionally or
unintentionally, do not adversely affect process characteristics
and product quality
● Divided into two categories based on purpose,

○ Re- validation in case of known change
○ Periodic Re- Validation carried out at scheduled intervals.
● Changes of raw materials ( Physical properties
such as density, viscosity, particle size)
Changes that
are likely to
● Change of Starting material
require Re-
● Change of Packing material
Validation
● Changes of the process parameters ( Mixing
Time, Drying temperature)
● Changes of Equipment
● Production are and Support system changes

Thank You !

Process Validation

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PROCESS

For Large Volume Parenteral (LVP)

Stage 1 Stage 2 Stage 3

02 Concurrent Validation 04 Re- Validation

● Carried out during the development stages by means of a risk

• Objective, Scope, Responsibilities

● Validation process is divided into two type depending upon the

● Documented process done as per the prospective validation

● Divided into two categories based on purpose,

● Production are and Support system changes

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