A Brief Review on Pharmaceutical Validation

Abstract

Validation is the procedure which authorizing documentary evidence that proves the following process will consistently produce the product which leads to the expected result. According to GMP validation studies are important part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. Validation is the one of the important part in achieving and maintaining the quality of the final product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers a high degree of assurance and evidence that the process, which is being carried out gives out the uniform results, that is, it means the required specifications, which has been performed accurately. The purpose of this review is to present an introduction and general review on validation in pharmaceutical industry.

Full text

Asian Journal of Pharmaceutical Analysis. 12(3): July - September, 2022
211
ISSN 2231–5667 (Print)
2231–5675 (Online)
DOI: 10.52711/2231-5675.2022.00035
Vol. 12 | Issue-03|
July - September| 2022
Available online at
www.anvpublication.org
www.asianpharmaonline.org
Asian Journal of Pharmaceutical Analysis
Home page www. ajpaonline.com
REVIEW ARTICLE
A Brief Review on Pharmaceutical Validation
Darshan A. Salade*, Kishor S. Arote*, P. H. Patil, Vikas V. Patil, Amol R. Pawar
Department of Quality Assurance, Kisan Vidya Prasarak Sanstha's,
Institute of Pharmaceutical Education, Boradi 425405.
*Corresponding Author E-mail: kishorarote770@gmail.com
ABSTRACT:
Validation is the procedure which authorizing documentary evidence that proves the following process will
consistently produce the product which leads to the expected result. According to GMP validation studies are
important part of GMP these are required to be done as per predefined protocols, the minimum that should be
validated include process, testing and cleaning as a result such control procedure stablish to monitor the output
and validation of manufacturing processes that may be responsible for variability of drug product. Validation is
the one of the important part in achieving and maintaining the quality of the final product. The validation study
provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms,
shall be established and documented. Process validation is the process for improving the safety and quality of the
dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of
quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough
quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers
a high degree of assurance and evidence that the process, which is being carried out gives out the uniform
results, that is, it means the required specifications, which has been performed accurately. The purpose of this
review is to present an introduction and general review on validation in pharmaceutical industry.
KEYWORDS: Validation, Pharmaceutical Industry, Quality Assurance, GMP, Consistent.
INTRODUCTION:
The concept of validation was first proposed by two
Food and Drug Administration (FDA) officials, Ted
Byers and Bud Loftus, in the mid 1970’s in order to
improve the quality of pharmaceuticals. The prime focus
of validation is on ensuring if the quality is built into the
system at every step, and not just tested for at the end.1
Validation is a concept that has evolved in united states
in 1978.
Received on 02.05.2022 Modified on 18.05.2022
Accepted on 30.05.2022 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Ana. 2022; 12(3):211-217.
DOI: 10.52711/2231-5675.2022.00035
The concept of validation has expanded through the
years to embrace a wide range of activities from
analytical methods used for the quality control of drug
substances and drug products to computerized systems
for clinical trials, labelling or process control. Validation
is founded on, but not prescribed by regulatory
requirements and is best viewed as an important and
integral part of cGMP.2,3
The key purpose of all pharmaceutical industries is to
discover quality products consistently, at the lowest
possible cost. Validation plays a very significant role in
quality assurance and productivity improvement. Process
validation establishes the flexibility and constraints in
the manufacturing process controls in the attainment of
desirable attributes in the drug product while preventing

Asian Journal of Pharmaceutical Analysis. 12(3): July - September, 2022
212
undesirable properties.4,5
Validation mainly based on, FDA regulations describing
current good manufacturing practice (cGMP) for
finished pharmaceuticals are provided in 21 CFR parts
210 and 211. The cGMP regulations require that
manufacturing processes be designed and controlled to
assure that in-process materials and the finished product
meet predetermined quality requirements and do so
consistently and reliably. Process validation is required,
in both general and specific terms, by the cGMP
regulations in parts 210 and 211.6,7
Validation has become one of the Pharmaceutical
industry’s most familiar and discussed subjects. Its
critical success factor in product support and ongoing
commercialization. Quality is always an authoritative
requirement when we consider any product. Therefore,
the drugs must be manufactured to the highest quality
levels. Finished product testing by itself does not
assurance the quality of the product. A process
validation procedure is required as specified by the
current good manufacturing practices Regulations for
Finished pharmaceuticals and is therefore applicable to
manufacturing of drugs.8
Why Validation Is Required:
The pharmaceutical industry uses expensive material,
sophisticated facilities and equipment and highly
qualified personals. It would not be feasible to use
equipment not knowing if it will produce the product we
want, not to employ the people with no assurance that
they can do or fail to implement process checks or
examination to assure that product meet specification.
Detailed study and control of the manufacturing process
batch validation is necessary if failure cost is to be
reduced and productivity is improved. Validation is
helps in assurance of quality and reduction of cost. The
validation helps in reducing the reject, reworks, recalls
and complaints about the product.9
For existence of Safety, Quality, Efficacy1 in product. A
validated process gives High degree of pledge for
uniformity. Process validation does not improve
anything related to quality of the product, but control and
maintain the measures to fulfil requirements consistently
through adequate validations.10
Types of validation:
Fig.1-Types of validation
Process validation:
USFDA defined process validation as “establishing
documented evidence which provides high degree of
assurance that a specific process will consistently
produce a product meeting its pre-determined
specifications and quality characteristics.” Process
validation provides the flexibility and constraints in the
production process controls in the achievement of
desirable qualities in the drug product while preventing
undesirable attributes.11,12
Types of Process Validation:
A) Prospective process validation:
It is defined as the established documented evidence that
a system does what it implications to do based on a pre-
planned protocol. This validation usually carried out
prior to distribution either of a new product or a product
made under a revised manufacturing process performed
on at least three successive production batches.13
The objective of the prospective validation is to prove or
demonstrate that the process will work in accordance
with validation protocol prepared for the pilot production
trials. Prospective validation should normally be
completed prior to the distribution and sale of the
medicinal product. In Prospective Validation, the
validation protocol is executed before the process is put
into commercial use. During the product development
phase the production process should be broken down
into individual steps. Each step should be evaluated on
the basis of experience or theoretical considerations to
determine the critical parameters that may affect the
quality of the finished product. A series of experiments
should be designed to determine the criticality of these
factors. Each experiment should be planned and
documented fully in an authorized protocol.14,15

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Prospective process validation is executed after the
completion of the R and D trial in order to produce the
product for the commercial purpose. This is one of the
crucial part of the process validation as most validation
efforts depends on the prospective experimentation so
that data that support the validation could be generated.
This type of validation is generally connected with the
introduction of new drug product into the market and
involves the studies of all their manufacturing
processes.16
Prospective validation should include the following
1. Short description of the process
2. summary of the critical processing steps to be
investigated
3. List of the equipment’s to be used along with their
calibration status
4. Finished product specifications for release
5. List of analytical methods
6. Proposed in-process controls with acceptance criteria
7. Additional testing to be carried out
8. Sampling plan
9. Methods for recording and evaluating results
10. Functions and responsibilities.17
B) Concurrent Process Validation:
The concurrent process validation establishes
documented evidence that the process is in a state of
control during the actual execution of the process. The
in-process testing and/or monitoring of critical
operations during the manufacture of each production
batch is done for concurrent process validation.18
It is a process where current production batches are used
to monitor processing parameters. It gives of the present
batch being studied, and offers limited assurance
regarding consistency of quality from batch to batch.
After three initial commercial batches are taken and the
process is handed over to the manufacturing facilities,
batch after batch and studied if any deviation is observed
or required. This time the in-process quality control
parameter are also decided and monitored which finally
becomes the I.P.Q.C. test for regular production.17
Concurrent Validation may be the practical approach
under certain circumstances. Examples of these may be
when:
• A previous validated process is being transferred to a
third-party contract manufacturer or to another site.
• The product is a different strength of a previously
validated product with the same ratio of
active/inactive ingredients.
• The number of lots evaluated under the Retrospective
Validation were not sufficient to obtain a high degree
of assurance demonstrating that the process is fully
under control.
• The number of batches produced are limited.19
C) Retrospective Process validation:
It is defined as established documented evidence that a
system does what it purports to do on the review and
analysis of historical information. This is achieved
through the review of the historical manufacturing
testing data to prove that the process has always
remained in control. (20) It is conducted for a product
already being marketed, and is based on extensive data
accumulated over several lots and over time.
Retrospective Validation may be used for older products
which were not validated by the fabricator at the time
that they were first marketed, and which is now to be
validated to confirm to the requirements of division 2,
Part C of the Regulation to be Food and Drugs Act.
Retrospective Validation is only acceptable for well-
established detailed processes and will be Inappropriate
where there have recent changes in the formulation of
the products, operating procedures, equipment and
facility.21,22
The retrospective process validation should contain the
following
• Batches manufactured for a defined period
(minimum of 10 last consecutive batches)
• Number of lots released per year
• Batch size/strength/manufacturer/year/period
• Master manufacturing/packaging documents
• Current specifications for active materials/finished
products
• List of process deviations, corrective actions and
changes to manufacturing documents
• Data for stability testing for several batches
• Trend analyses including those for quality related
complaint23
D) Revalidation:
Required when there is a change in any of the critical
process parameters, formulation, primary packaging
components, raw material fabricator, major equipment or
premises. Failure to meet product and process
specifications in batches would also require process re-
validation. Re-validation provides the evidence that
changes in a process and/or the process environment that
are introduced do not adversely affect process
characteristics and product quality. Documentation
requirements will be the same as for the initial validation
of the process.24,25
Revalidation becomes necessary in certain situations.
Some of the changes that require validation are as
follows:
• Changes in raw materials (physical properties such as
density, viscosity, particle size distribution and
moisture etc., that may affect the process or product).

Asian Journal of Pharmaceutical Analysis. 12(3): July - September, 2022
214
• Changes in the source of active raw material
manufacturer.
• Changes in packaging material (primary
container/closure system)
• Changes in the process (e.g., mixing time, drying
temperatures and batch size)26
Stages of Process Validation:
Process Validation is explained as the group and
assessment of data, from the process design stage and
between commercial production, which gives scientific
confirmation that a process is capable of continually
delivering quality product. Process Validation require a
sequence of activities taking place over the lifecycle of
the product and process. The venture relating to
validation studies may be categorized into three stages:8
Stage 1
Process Design
confirmation
Stage 2
Process Qualification
Design of
facilities and
qualification
of
equipment &
utilities
Process
Performance
Qualification
Stage 3
Continued process
validation
Distribute
Fig. 2 – Stages of process validation
Stage 1 – Process Design:
This stage is to design a process suitable for routine
commercial manufacturing based on knowledge gained
through development and scale-up activities that can
consistently deliver a product that meets its quality
attributes. This stage provides a key input to the studies
that are carried without the application of good
manufacturing practices, during the product development
studies which ultimately helps in the various design
stages such as anticipated dosage form, manufacturing
route.27
Stage 2 – Process Qualification:
During this stage, the process design is confirmed as
being capable of reproducible commercial
manufacturing. It confirm that all established limits of
the Critical Process Parameters are valid and that
satisfactory products can be produced even under “worst
case” conditions.28
Process qualification has two stages. They are:
1. Design of the facility and qualification of the
equipment and utilities
2. Process performance qualification (PPQ), in this
stage CGMP-compliant procedures must be
followed.
3) Stage 3 – Continued process validation:
All the continual data assembled to sustain the quality of
product are evaluated in the third stage. The goal of the
third validation stage is ongoing assurance is gained that
the process remains in a state of control during routine
commercial manufacturing.21
Phases of process validation:
1) Phase 1:
Phase 1 is also called as Pre-validation Qualification
Phase. It covers all activities relating to product research
and development, formulation pilot batch studies, scale-
up studies, transfer of technology to commercial scale
batches, establishing stability conditions and storage and
handling of in-process and finished dosage forms,
equipment qualification, installation qualification, master
production document, operational qualification and
process capacity.29
2) Phase 2:
Phase 2 is also called as process validation phase. It is
designed to verify that all established limits of the
critical process parameter are valid and that satisfactory
products can be produced even under the worst
conditions.30
3) Phase 3:
Phase 3 is also called as validation maintenance phase. It
requires frequent review of all process related
documents, including validation of audit reports, to
assure that there have been no changes, deviations
failures and modifications to the production process and
that all standard operating procedures (SOPs), including
change control procedures, have been followed.31
Equipment validation:
Equipment validation is established documented set up
that proves any equipment works correctly and leads to
accepted and accurate results. The process of equipment
validation is based on the principle that equipment must
be designed, constructed, maintained, and adapted to
perform the operations which are to be carried out.32
Types of Equipment Validation:
A) Design Qualification:
“It is a documented verification that the proposed design
is suitable for intended purpose.” The design
qualification outline the key features of the system
designed to address the user requirements, regulatory
compliance and selection rationale of a particular
supplier.33

Asian Journal of Pharmaceutical Analysis. 12(3): July - September, 2022
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Important DQ consideration include:
1. GMP‟s and regulatory requirements.
2. Performance criteria.
3. Facility air flow, movement flow and pressure
regimens.
4. Reliability and efficiency.
5. Commissioning requirements
6. Construct ability and installation of equipment.34
B) Installation Qualification:
It is a documented verification that all the aspects of a
facility, utility or equipment that can affect product
quality adhere to approved specifications and are
correctly installed. Establishing confidence that process
equipment and ancillary systems are capable of
consistently operating within established limits and
tolerances food and drug administration (FDA).35
Important IQ consideration include:
1. Installation conditions (wiring, utilities, and
functionality)
2. Calibration, Preventive maintenance, cleaning
schedules.
3. Safety features.
4. Supplier documentation, prints, drawings and
manuals.
5. Software documentation
6. Spare parts list.34
C) Operational Qualification:
It is a documented verification that all aspects of a
facility, utility or equipment that can affect product
quality operate to intend throughout all anticipated
ranges. During OQ, critical operating parameters for the
equipment and systems should be identified and studies
are carried out for critical variables. Studies includes
condition or a set of conditions including both upper and
lower operating limits referred to as “worst case”
conditions.36
OQ considerations include:
1. Process control limits (time, temperature, pressure,
line speed, and setup conditions).
2. Software parameters.
3. Raw material specification.
4. Process operating procedures
5. Material handling requirements.
6. Process change control
7. Training
8. Short term stability and capability of the process34
D) Performance Qualification:
It is a documented verification that all aspects of a
facility, utility or equipment perform as intended in
meeting predetermined acceptance criteria. PQ is
establishing confidence that the process is effective and
reproducible, establishing confidence that a process in
accordance with the design qualifications.37
PQ consideration include:
1. Actual product and process parameters and
procedures established in OQ.
2. Acceptability of the product.
3. Assurance of process capability as established in OQ.
4. Process repeatability, long term process stability.34
Re-Qualification:
It means ensuring that the equipment is in the state of
control after any changes or certain time period and
periodic assessment of the equipment within defined
intervals is called re-qualification. This should be done
with proper review and documentation has to be done.
The review should summarize the need for re-
qualification. The Preventive Maintenance Program and
Documentation system is required to handle small
alterations with no direct effect on final or in-process
product quality.38
Validation life cycle:
Validation is a continuing and evolving process. The
validation process which extends from very basic to very
broad theoretical and methodical investigation of how
the system and processes perform. Its scope
encompasses documentation revision control, training
and maintenance of the system and process. Evidence of
validation should be seen at the corporate level and be
reflected in the management structure. Validation is a
method for building and maintaining quality.39
NO
YES
START
DEFINE
PROCESS
DEFINE THE
SYSTEM
SYSTEM
MEET
NEEDS OF
PROCESS
QULITY THE SYSTEM
SYSTEM
MEET
REQUIRE
MENTS
QULITY PROCESS
CONTINUED
VALIDATION
REDESIGN
OPTIONAL
YES
NO
Fig. 3 – Validation life cycle

Asian Journal of Pharmaceutical Analysis. 12(3): July - September, 2022
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Advantages of validation:
1. Consistent through output.
2. Reduction in rejections and reworks.
3. Reduction in utility cost.
4. Avoidance of capital expenditures.
5. Fewer complaints about process related failure.
6. Reduced testing process and finished goods.
7. More rapid and accurate investigations into process
deviation.
8. More rapid and reliable start-up of new equipment.
9. Easier scale-up from development work.
10. Easier maintenance of equipment.
11. Improve employee awareness of processes.
12. More rapid automation.40
Disadvantages of validation:
1. Validation is time consuming process.
2. The process for manufacture is often complex and
costly.
3. Validation also has practical limit and related cost.
Application of validation41
Reduction of quality cost:
Through correct validation, cost of the following
procedures can be improved.
a) Preventive costs can incurred in order to prevent
failure and reduce appraisal costs.
b) Appraisal costs of inspection, testing and quality
evaluation.
c) Internal failure costs
Process Optimization:
The development of the facility, equipment system,
closures etc. results in a product that encounter quality
necessities at the lesser costs. Trained and qualified
personnel’s are the key elements in the process
optimization that results in upgrading efficiency and
productivity.
Assurance of quality:
Validation and the process control are one of the
important protocols of GMPs. Without validation and
controlled process, it is impossible to attain quality
products. Hence validation is a key element in assuring
the quality of the product.
Safety:
Validation can also result in increased worker safety.
Properly standardized, validated instruments and devices
are used to reduce accidents and results in safety.
Validation can also result in the increase in operation
safety. e.g. instruments used on equipment that intended
to operate at certain temperature and pressures must be
dependable i.e. They need to be calibrated.
Better consumer quality:
Through proper validation, market recall is evaded
which results in better consumer care and quality of the
product. Quality costs are divided in to four categories.
They are:
1. Preventive costs.
2. Appraisal costs.
3. Internal failure costs.
4. External failure costs
CONCLUSION:
This review gives an idea about the validation in
pharmaceutical industry. Validation is an essential
component of GMP. Validation helps assure product will
meet standard quality, safety, efficacy, purity,
effectiveness according to GMP. Validation is
commonly used in drug development, manufacturing and
specification of final product. Validation is helps in
eliminating the chances of batch failure as the product
are manufactured under optimizing each manufacturing
stage. Validation helps in reduce the cost of quality
which gives the best quality of product. Validation
includes a sequence of activities taking place in the
lifecycle of product and process. Finely the
pharmaceutical validation helps to provide a positive
assurance of batch consistency and integrity of final
product which is manufactured under rules and
regulations of GMP.
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