1. Why Validation Matters: A Brief Guide to a Critical Aspect of the Pharmaceutical
Manufacturing Lifecycle
June 3, 2013
Barry Peters and Heather D. Ferrence | Telerx
According to the World Health Organization (WHO), the process of qualification and validation is
applicable to any aspect of operation that may affect the quality of the product either directly or
indirectly. The primary goal of the validation process in the pharmaceutical industry is to have
documented proof that quality is part of each and every step of the manufacturing and distribution
system, instead of merely testing products at the end of the process.
The Food and Drug Administration (FDA) has set recommendations for all stages of the
manufacturing process lifecycle, whether related to plant equipment, software or risk
management. Furthermore, the FDA has the authority and responsibility to inspect and evaluate
the validation process performed by manufacturers.
Whether it is due to government regulation, cost effectiveness or quality assurance, the
pharmaceutical industry cannot ignore the necessity of a proper validation process.
Defining Validation (in the Pharmaceutical Manufacturing Process)
The term validation in the context of pharmaceutical manufacturing can easily be misinterpreted
and because of that, companies must define specifically what it means for them and detail how
exactly they will implement it in order to achieve the desired results. A defined validation
methodology is critical in determining the scope of validation required. The Validation Plan
should detail the risk based approach taken to balance business requirements, operational and
procedural controls while meeting regulatory requirements. It is important to have proven
techniques to find cost efficiencies associated with implementing, using, and maintaining
computer systems in regulated environments.
Often, companies tend to either overdo or underdo it. Lack of knowledge about how and what to
validate can translate into too much documentation because of uncertainty as to where to draw
the line or not enough information because the validation task seems so daunting. One overkill

2. example includes; from a testing standpoint, if an area chooses to report information over and
above what is included in the requirements, their system providers, whether in-house or third
party, need to be aware to adjust their testing systems accordingly. Otherwise, that
incompleteness could be misconstrued as a deficiency. An example of underdoing includes the
lack of traceability from the requirements through the executed test protocols.
Additionally, many companies mistakenly believe that the term “validation” is solely IT-centric,
when in fact the concept of validation involves a number of aspects beyond computer system
validation, including, but not limited to: the input, the outputs, the users, equipment, facilities, ,
cleaning, process, and analytical method.
In sum, and as defined by the FDA, process validation is the collection and evaluation of data,
from the process design stage through the end of the product lifecycle. This ongoing compilation
of data provides the basis for established scientific evidence which concludes that a process is
capable of consistently delivering quality product.
The Importance of Validation
The Federal Food, Drug and Cosmetics Act Section 501 (a)(2)(B) which states that “a drug is
deemed to be adulterated if the methods used in, or the facilities or controls used for, its
manufacture, processing, packing, or holding do not conform to or were not operated or
administered in conformity with Current Good Manufacturing Practices (CGMPs),” serves as the
legal basis for the practice of validation.
In today’s world of recalls and lawsuits, it is imperative that pharmaceutical manufacturers
develop a Validation Master Plan and thoroughly document how the validation process is carried
out.
As more pharmaceutical companies find themselves outsourcing a variety of customer-facing
services to third-party vendors, the role of a contact center is an important one during the life of a
product, as interactions with consumers and medical professionals become crucial for traceability.
In an environment where consumer safety and privacy are front and center, a carefully
documented system and process leaves no room for questions during an audit, internal or
external investigation or government-mandated recalls.
Companies that are a part of product complaint and adverse event processing or companies that
need to meet the requirements of core areas of global data protection and privacy standards must
have well thought out validation processes and detailed documentation.
The chain of events resulting from consumer complaints, whether using a third-party contact
center or performing consumer engagement duties in-house, illustrates why validation is
critical. For example, call takers must document each consumer complaint in great detail, such
as product information, lot number, personal patient information and other medication the patient
was taking at the time of the product problem. Each file is then routed to the quality unit within
the manufacturer to run additional reports on that particular lot to determine how many other
similar reports exist. Depending on the reports, companies can take a variety of next testing steps
to determine the cause of the defect and how widespread it may be. Depending on the outcome

3. of the testing, or whether the FDA determines that they must conduct a general investigation on a
particular product, all the necessary documentation must be up to date, available and traceable
from the requirements to the finished product.
The Bottom Line
As companies work to reduce product failures, rejects and reworks, they must avoid some of the
most common challenges of a validation process such as: lack of time, lack of personnel, lack of
experience and knowledge and poorly designed documents. By implementing a successful
validation process, pharmaceutical manufacturers can improve productivity, reduce recalls and
consumer complaints and also reduce the burdensome process of investigations.