Process chemistry, process validation, stages of process validation , types and objectives of process validation , application, significance, principle , validation protocol

1. IN PROCESS CONTROLAND
PROCESS VALIDATION
SUBMITTED BY:
UPASANA SHARMA
(M.PHARMA:PHARMACEUTICAL
CHEMISTRY)
SUBMITTED TO:
Dr. RAKHI MISHRA
(PROFESSOR)
NOIDA INSTITUTE OF ENGINEERING AND TECHNOLOGY
(PHARMACY INSTITUTE )
GREATER NOIDA 1
UPASANA SHARMA (Pharmaceutical Chemistry)

2. Process Validation :
• Establishing documented evidence which provides a high degree of assurance
that a specific process will consistently produce a product meeting its pre-
determined specifications and quality attributes.
• The process validation describe activities in three stages.
Stage 1 – Process Design
Stage 2 – Process Qualification
Stage 3 – Continued Process Verification
Process Design: During this
stage the commercial
manufacturing process is
defined based on knowledge
gained through development
and scale-up activities.
Process Qualification: During
this stage, the process design is
evaluated to determine if the
process is capable of
reproducible commercial
manufacturing.
Continued Process Verifi
cation: Ongoing assurance
is gained during routine
production that the process
remains in a state of
control.
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UPASANA SHARMA (Pharmaceutical Chemistry)

3. GENERAL
CONSIDERATIONS FOR
PROCESS VALIDATION
 An integrated team approach
to process validation that
includes expertise from a
variety of disciplines.
 All studies should be planned
and conducted according to
sound scientific principles,
appropriately documented, and
approved in accordance with
the established procedure
 Homogeneity within a batch
and consistency between
batches are should be the goals
of process validation activities.
OBJECTIVES
 To establish a record keeping system that
considers all concept of manufacturing process
which includes controlled testing.
 To evaluate all possible sources of variation in
process.
 To identify all sources of variation those are
possible from the materials, machines, methods
and men.
 To evaluate the requirement for in-process
testing and evaluation.
 To document everything that is done to follow
establish procedures and protocols as closely as
possible.
 To maintain Quality, safety and effectiveness
must be designed and built in to the product.
 To get the Quality must be assured. 3
UPASANA SHARMA (Pharmaceutical Chemistry)

4. WHEN IS VALIDATION NEEDED?
Before introduction of a new method into
routine use
Whenever the conditions change for which
a method has been validated, e.g., instrument with
different characteristics
Whenever the method is changed, and the change
is outside the original scope of the method
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UPASANA SHARMA (Pharmaceutical Chemistry)

5. PROCESS VALIDATION:
ORDER OF PRIORITY
A) Sterile product and their
processes
1. large volume parenteral
2. Small volume parenteral
3. Ophthalmics, other sterile
products, and medical devices
B) Non sterile products and their
processes
1. low dose/ high potency tablets
and capsules
2. drugs with stability problems
3. other tablets and capsules
4. oral liquids, topicals, and
diagnostics aids
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UPASANA SHARMA (Pharmaceutical Chemistry)

6. TYPES OF PROCESS VALIDATION
Prospective-
Process Validation
 An experimental plan
called the validation
protocols executed
before the process is
put into commercial
use.
 It is normally carried
out in connection with
the introduction of
new drug products and
their manufacturing
processes.
Retrospective Process
Validation
 It is chosen for established
products whose manufacturing
processes are considered stable
and when on the basis of economic
considerations alone and resource
limitations, prospective validation
programs cannot be justified.
 The equipment, facilities and
subsystems used in connection
with the manufacturing process
must be qualified in conformance
with CGMP requirements.
Concurrent Process
Validation
 It is in-process
monitoring of critical
processing steps and
end-product testing of
current production.
 It can provide
documented evidence
to show that the
manufacturing
process is in a state of
control.
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UPASANA SHARMA (Pharmaceutical Chemistry)

7. PROCESS RE-VALIDATION:
 Required when there is a change
in
 Any of the critical process
parameters
 Formulation
 Primary packaging components
 Raw material
 Major equipment or premises.
 Failure to meet product and
process specifications in batches
would also require process re-
validation.
BASIC PRNCIPLE FOR PROCESS
VALIDATION:
The individual qualification steps alone do not
constitute process validation.
1. Installation Qualification (IQ)
2. Operational Qualification (OQ)
3. Performance Qualification (PQ)
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UPASANA SHARMA (Pharmaceutical Chemistry)

8. Operational
Qualification
(OQ):Operational
qualification (OQ) is the
process of demonstrating
that an instrument will
function according
to its operational specifica
tion in the selected
environment.
Installation
Qualification (IQ):
Installation qualification
establishes that
the instrument is received as
designed and specified, that
it properly installed in the
selected environment, and
this environment is suitable
for the operation and use of
the instrument.
Performance Qualifica
tion (PQ):
Performance Qualification is
the process of
demonstrating that instrume
nt consistently performs
according to a
specification appropriate for
its routine use.
PRINCIPLE:
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UPASANA SHARMA (Pharmaceutical Chemistry)

9. VALIDATION TEAM
 Personnel qualified by
training and experience
in a relevant discipline
may conduct such
studies.
 The working party
would usually include
the following staff
members such as;
 Head of quality
assurance.
 Head of engineering.
 Validation manager.
 Production manager.
 Specialist validation
discipline: all areas.
VALIDATION
PROTOCOL
 The validation protocol
should contain the following
elements,
 Short description of the
process.
 Summary of critical
processing steps to be
investigated.
 In process, finished product
specification for release.
 Sampling plans.
 Departmental
responsibility.
 Proposed timetable.
 Approval of protocol
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UPASANA SHARMA (Pharmaceutical Chemistry)

10. THE VALIDATION
REPORT
The report should include at least the
following
Title and objective of study.
Reference to protocol.
Details of material.
Equipment.
Programmes and cycles used.
Details of procedures and test methods.
Result.
Recommendations on the limit and
criteria to be
applied on future basis.
IMPORTANCE OF PROCESS
VALIDATION
Improve the use of technology
Improve the business benefits
Improve operational efficiency
Improve compliance with
regulations
Reduce the risk of failure
Reduce the cost
Process optimization
Increased customer satisfaction
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UPASANA SHARMA (Pharmaceutical Chemistry)

11. CONCLUSION:
• Validation is one of the important steps in achieving and maintaining
the quality of the final product.
• If each step of production process is validated we can assure that the
final product is of the best quality.
• Finally it can be concluded that process validation is a key element in
the quality assurance of pharmaceutical product as the end product
testing is not sufficient to assure the quality of finished product.
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UPASANA SHARMA (Pharmaceutical Chemistry)

12. THANK YOU
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UPASANA SHARMA (Pharmaceutical Chemistry)