Pharmaceutical Validation: Importance, Advantages, and Process

Pharmaceutical Validation 1
Pharmaceutical Validation
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Pharmaceutical Validation 2
Introduction
The concept of validation in the pharmaceutical industry has continuously been explored
from 1978 in the U.S and even further advanced since 2011 as a result of technological
development. The idea of validation has grown over the past decade to incorporate some
activities from the quality control of medications using analytical methods to technical
applications for clinical trials (Walsh et al., 2013). Therefore, validation is an aspect of
quality assurance related to specific criteria. However, there exists a wide range of
differences in criteria, and thus no general approach to validation and governing bodies like
EC and FDA have designed universal optional procedures.
Validation can, therefore, be defined as providing documented evidence that offers high
assurance. It is an integral element of quality assurance. A validated process is that which has
been shown to provide a high assurance level that same lots will be generated that is up to
expected specifications and thus has been approved officially (Sonawane et al., 2014).
According to Boussadi et al. (2011) validation in itself doesn’t enhance processes but
approves that the processes have adequately been designed in accordance with established
procedures.
Advantages of Validation
Validation of pharmaceutical productions has given insight into the manufacturing processes,
minimized the risk of averting difficulties and therefore guarantees the smooth flow of the
production process. Parida (2010) observes that processes that undergo constant validation
demands minimal support and takes less time. Validation has ensured that batch failures are
at minimum and output is maximized. Furthermore, proper validation is reflected in product
quality which is likely to expedite pre-approval inspection and the rewarding of marketing
authorization. Validation has also reduced utility cost (Active Pharmaceutical Ingredients
Committee (APIC), 2014).

Pharmaceutical Validation 3
Reasons for Validation
APIC (2014) assert that validation makes good business sense because without it would not
be viable to utilize equipment which one is ignorant about. Pharmaceutical validation is
necessary because the industry invests in costly materials, equipment, and experts. This
necessitates the effective use of these resources to ensure the success of the pharmaceutical
industry. Additionally, any product failures, rework, recalls, and protests are some of the
critical elements that contribute to the production cost. According to Boussadi et al. (2011)
validation is inevitable if the total production cost is to be minimized.
Process Validation
Process validation implies developing formal documentation of evidence which outlines the
highest level of standard that a given system will endeavor to meet during production and
quality of products.
Types of Process Validation
There are four main types of validation namely retrospective, prospective, concurrent
validation, and revalidation. Retrospective validation is the development of documented
evidence before process implementation so that a system undertakes what it is expected to do
according to pre-established protocols. Retrospective validation is usually carried out when
the process of a new formula requires validation before the initiation of pharmaceutical
production (Wazade, Walde, and Ittadwar, 2012).
Prospective Validation is an approach applicable to processes, facilities and process controls
that are in use yet have not undergone a documented process of validation. Prospective
validation is carried out before a new product or production process is introduced. The
process of validation is accomplished, and the outcomes are sanctioned before any of them is
released to the market, thus establishing formal evidence before process implementation that

Pharmaceutical Validation 4
a system is undertaken based on the already established protocols (Sajid, Arayne, and
Sultana, 2010).
Concurrent validation is the same as prospective, except that the manufacturing company will
release the product to the market during the qualification process at market price. This
process comprises monitoring of significant processing procedures and product trials. This
approach involves the replication of a validation process or some portion of it. The process is
undertaken when a change or substitution takes place in the formulation, equipment or site
location (Sajid, Arayne, and Sultana, 2010).
Revalidation comprises of the replication of the original validation or any of its section and
entails analytical assessment of the current performance data. Revalidation is significant in
the maintenance of approved status of the equipment, plant, production processes and
computer systems. This approach can be initiated during the transfer of products between
plants and when there is a need for routine monitoring of the outcomes of validation.
Furthermore, the method is applicable when there is a substantial variation in batch size. It is
also important to note that the scope of revalidation procedures rely on the degree of changes
and the impact on the product (Wazade, Walde, and Ittadwar, 2012).
Phases in Process Validation
The activities associated with validation studies can be categorized into three phases:
Phase 1
This is the phase of pre-validation and includes all activities associated with product research
and growth, development of pilot batch studies, relocation of technology to business scale
batches, and qualification of equipment.