APR May/June 2023 - 62

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MICROBIOLOGY
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Method Validation/Verification:
How Important is it in Your QC Microbiology Laboratory?
Laurie Boyd, MBA, AT
Manager, Quality Control
A mid-sized biopharmaceutical company
Introduction
Method Validation/Verification? The ever so daunting words in any
Good Manufacturing Practice (GMP) Quality Control (QC) Microbiology
Laboratory. If you are a new lab manager and/or analyst just starting
in the pharmaceutical industry, various questions come to mind when
you think of these terms: Method Validation and Method Verification.
As these questions start forming, you may ask yourself " Why do we
need to do method validation or verification? Which methods do I
use when validating my product? When do I validate my laboratories
methods? Where do I even begin? Who is requiring me to execute
these in my lab? What is required to have a successful validation? "
Even though it may be daunting and overwhelming, it is one of the most
important requirements to any GMP QC Microbiology Laboratory; the
understanding of regulatory expectations is imperative for a strong
release testing program. Regulatory entities aim to confirm your test
method is producing accurate and reliable results to demonstrate your
product is safe for the public. Unfortunately, over the last couple of
years, auditors have given multiple observations for method validation
gaps found during inspections across the industry. The goal of QC is to
mitigate these observations by understanding the regulation entities'
expectations for method validations and method verifications.
Definition
Let's start at the beginning: What are Method Validation and Method
Verification in the pharmaceutical industry?
These two terms are typically interchangeable in the beginning stages
of method development.
Method Verification is the primary method development strategy in
the QC Microbiology lab. Method verification is " the ability to verify
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that a method can perform a method reliably and precisely for its
intended purpose. " 1
QC Microbiology generally benefits from the
majority of methods being validated by pharmacopeial chapters such
as Harmonized (across all pharmacopeial entities) USP General Chapter
methods <61> Microbiological Examination of Nonsterile Products:
Microbial Enumeration Tests <62> Microbiological Examination of
Nonsterile Products: Test for Specified Microorganisms, <71> Sterility
Testing, <85> Bacterial Endotoxin Testing. The implementation of these
microbiological methods consists of verifying that the compendial
validated method is suitable for the sample and the lab setting.
The area of Analytical Method Validation is typically executed in the QC
Analytical Chemistry Laboratories. Method Validation can be defined
in accordance with the United States Pharmacopeia, Chapter 1225 as
" a process by which it is established, through laboratory studies, that
the performance characteristics of a method meet the requirements
for its intended analytical applications. " 1
But why do we need to define and understand the differences
between validation and verification? For many years, the QC
microbiology labs in the pharmaceutical industry have been
moving towards a more modern method approach to improve
release timelines for products to market. The more traditional
methods can have long incubation times and be cumbersome when
products need to meet patient and market demand. As these new
modern methods become more in demand, the understanding of
Analytical Method Validation becomes more important for the QC
Microbiology lab analyst. Since microbiological methods typically
follow the compendial validated method and are verified prior to site
implementation, the understanding of Method Validation becomes
vital for the implementation of modern methods. To fully understand
Method Validation, one must understand the required parameters to
ensure the implemented method is well-designed.
Let's go into more depth and really understand the 5 " W's " of Validation:
Why, Who, When, What and Where
APR May/June 2023

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