n 18 JULY/AUGUST 2015 | PHARMACEUTICAL PROCESSING
nPHARMPRO.COM n VALIDATION
What is the difference between validation and qualification? Very often, the terms are intermingled. To help clear the confusion, “things” are qualified, while the ways they
are “used” (processes) are validated. Validation aims to solve
a single problem: accelerating approval from regulatory bodies in order to bring a product to market.
Validation by definition is the action
of proving -- in accordance with the principles of GMP -- that
any procedure, process, or activity will
a product that meets
set quality guidelines.
an inherent part of
validation and is the
action of proving -- in
accordance with the principles of GMP -- that any equipment,
material, facility or system is able to achieve the expected
As an example, the FDA defines process validation as the
collection and evaluation of data, from the process design
stage through commercial production, which establishes
scientific evidence that a process is capable of consistently
delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product
and process with the goal of identifying potential hazards,
failures and contamination.
In short, validation is an integral part of quality assurance.
However, it doesn’t necessarily secure the supply chain by col-
lecting the necessary data points that provide visibility from
the origination of raw materials to their final destination.
Systech sees the future of validation going far beyond this fi-
nite definition as it relates to quality assurance. As we migrate
toward a better, more effective means of validation, manufac-
turers will seek documentation to help ensure that systems, fa-
cilities and processes deliver uniform batches, which will meet
required specifications and subsequent approvals.
In addition, it is Systech’s view that it is becoming ever
more important to focus on the origins of raw materials so
they can be traced back through the supply chain prior to
manufacture –including being able to validate authenticity to
address questions like: Is this a real shipment? Was our sup-
ply chain contaminated or infiltrated?
In order to bring a drug to market, procedures for each
step in a drug’s creation and how it will be consistently,
repetitively produced -- backed by scientific evidence -- is
validated. However, as the product moves and scales into
the manufacturing cycle, the risks associated with producing
multiple batches in a variety of locations introduce a myriad
of pitfalls, specifically around contamination.
This is becoming more apparent with the steady growth
of counterfeiting, which is fueled by the general demand
on firms to do more with less (increase profits). The use
of lower-cost materials combined with an increase in outsourced manufacturing in a rush to meet evolving compliance
guidelines can be a recipe for disaster.
At this point, the risks start to scale exponentially as con-
taminants begin to enter the supply chain at various stages
in the process, from the sourcing of raw materials all the way
to packaging, before they even enter the distribution chain.
The consequences often lead to:
• Inferior quality products.
• Bulk recalls.
• Quarantined product.
Pharmaceutical Validation &
Beyond: Creating a Trusted
The ability to track raw material sources before they hit the manufacturing line
adds a critical layer of supply chain security. After all, no one wants sawdust
turning up in baby powder.
n By Jim Lee, Vice President of Product Management, Systech