Quality control is something that has always
been essential in the pharmaceutical industry. Nothing should leave the factory
floor until it’s been checked and double-checked, ensuring that everything
meets the expected parameters. Unfortunately, with most modern analog
pharmaceutical quality control programs overseen by human agents, there is
always the risk of and potential for human error, no matter how many
redundancies are in place.
By Emily Newton
New technologies are helping to ensure nothing
is overlooked during the quality control phase. Why is the future of
pharmaceutical quality control shifting to digital?
Quality and Compliance
The terms “quality” and “compliance” are often
used interchangeably, but they are not the same thing. Something meeting
compliance standards may not also meet the quality standards set forth by the
manufacturer, and vise versa. Keeping track of all of these different standards
can often be a challenge, even for the most experienced pharmaceutical
engineer. When it comes down to it, there are three primary goals for any
product emerging from the pharmaceutical industry:

●
Quality
●
Safety
●
Efficacy
Compliance regulations are the bare minimum that each product needs
to meet, according to the FDA or other regulatory bodies. They aren’t designed
with a single product or service in mind. Instead, they need to be general
enough that they can protect consumers while still covering anything that might
come out of the pharmaceutical industry. While it is possible to meet all
quality and compliance requirements manually, using analog techniques and
technologies isn’t the most efficient way to accomplish this task anymore —
especially for products in high demand.
Exploring Digital Options
Digital technologies in the pharmaceutical
industry are in their infancy, which means this is a perfect time to start
exploring those digital options. Right now, they’re an option. If the
technology gains a foothold in the pharmaceutical industry, it won’t remain
optional for long. Becoming an early adopter makes it easy for manufacturers to
find a niche and claim it for themselves.
Digital options can be broken down into two
categories: hardware and software. Hardware that can be applied to the
pharmaceutical industry includes but isn’t limited to:
●
Drones, robotics, and other forms
of automation.
●
3D printing.

●
Mobile devices and wearable
technology.
●
Smart sensors and the Internet of
Things (IoT).
●
RFID tracking and location
detection.
The software side of things can include, but
is not limited to:
●
Cloud computing.
●
Blockchain.
●
Big data analytics and machine
learning.
●
Artificial intelligence (AI) and
robotic processing analytics.
●
Virtual and augmented reality.
The potential applications for these
technologies are nearly limitless, both inside the production process and
inside the facility itself. Something as simple as a smart sensor attached to a
water intake pipe could aid in water conservation — an important part
of an industry that uses so much sterilized water in its production. Let’s take
a closer look at some of these tools and how they might shape the future of the
pharmaceutical industry.
Artificial Intelligence and Machine Learning
Pharmaceutical quality control generates a
massive amount of data. Testing parameters, results, variables, aberrations,
and more all get stored in a central database. From there, quality control
professionals can analyze the results and determine if a batch of products
meets the manufacturer’s quality standards. While this may have worked traditionally,
it isn’t as efficient as it could be.
Artificial intelligence and machine learning
programs can sort through the same data in a fraction of
the time, achieving the same or even better results faster and more
efficiently. Program these systems with the desired quality parameters and feed
them the data to get the desired results. As a bonus, the more information
these systems are exposed to, the smarter they become, making them even more
useful in the long run.

Improving Product and Process Development
Quality control doesn’t start at the end of
the production process. Every step of the process, from product and process
development to manufacturing and everything in between, can all play a role in
how successful a production run is. AI and machine learning, as well as other
digital tools, can help improve both product and process development steps,
reducing the chances that something could go wrong during production that would
result in a failed quality control check.
This application of digital technology has
mostly been restricted to consumer products, but it could easily make its way
into the pharmaceutical industry with a few modifications, making it easier for
manufacturers to ensure product quality throughout every step of the production
process.
Predicting Failures and Identifying Defects
Machine learning programs aren’t just useful
for analyzing data. With enough information, both current and historical, they
can work to predict failure points and defects before they even happen. As
previously mentioned, the more information these systems have to work with, the
smarter they become. They’re not predicting the future with any mysticism or
magic — simply analyzing past data and looking for patterns
that might not be immediately visible or obvious to a human analyst.
In a pharmaceutical production line, this
could provide invaluable opportunities, like identifying and predicting
problems before an entire batch of medication has to be discarded due to a
production error or failure. In addition to improving quality control
throughout the entire production process, this can also save companies a lot of
money by preventing discards or even recalls if something does manage to slip
past quality control.
Looking Toward the Future
Quality control is an essential part of any
industry that makes products for consumers, but for the pharmaceutical
industry, ensuring every pill, vial, or product that leaves the factory floor
meets the same high quality standards can mean the difference between life and
death. Digital services, like AI and machine learning, will continue
to shape the supply chain, including the pharmaceutical industry,
for the foreseeable future.
What currently exists as an option will likely
become a mandatory part of the industry moving forward. Pharmaceutical
companies looking for ways to improve their quality control processes should
start exploring these digital options. It’s the perfect opportunity to find a
niche and secure it before everyone else starts dipping their toes in the
metaphorical pool.
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Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)