Quality Assurance

Within pharmaceuticals, quality assurance (QA) is a largely proactive process,

focusing on preventing defects and minimising risks by ensuring
improvements in manufacturing, drug development, the supply chain, and
logistics—especially in the case of drugs, such as certain vaccines, which
require temperature-controlled environments to prevent spoilage and
unnecessary waste.

QA is often governed by an organisation’s quality assurance framework,

whether that is self-imposed, or following the guidance of an industry or
government body. These frameworks will often incorporate policies and
procedures that are central to guaranteeing products meet the necessary
standard, including clear instructions around:

• Purpose. A quality assurance framework in the pharmaceutical

industry aims to give the organisation, healthcare providers, and
consumers a clear assurance that drugs meet the most stringent
quality standards.
• Channels. All of the logistics and supply chain information
surrounding an organisation’s products should be identified,
alongside the potential bottlenecks that could occur and impact
production quality.
• Specific standards. Whether they’re imposed by the Medicines and
Healthcare Products Regulatory Agency (MHRA), the US Food and
Drug Administration (FDA), or any other regulator, QA relies on
meeting the standards set out in guidance to ensure that they can
take their products to market and mitigate risk.
• Metrics. The metrics a pharmaceutical firm needs to keep track of to
ensure they’re providing the highest quality will be set out clearly in
the quality assurance framework.
• Continuous improvement. Organisations putting a quality
assurance framework in place will not want to stay with the same
processes forever—even if they work well now, emerging
technologies and automation will continue to make the
manufacturing process safer and more efficient, so QA in
pharmaceuticals will require organisations to include details on how
they will continue to evolve their approach.
QA is a critical aspect of the pharmaceutical industry, giving consumers
confidence that the medications and therapeutic drugs they require to
remain healthy are safe and that manufacturing and drug development
processes are cost-effective and profitable. It is also of vital importance within
the regulatory affairs environment for pharmaceuticals and the MedTech
industry, helping to ensure that organisations can secure regulatory approval
to go to market with new developments.

The Advantages of Quality Assurance

So, what are the advantages of quality assurance? QA in pharmaceuticals

offers several commercial and consumer benefits, ensuring that potentially
costly—or dangerous—faults and recalls are avoided from the start of the
manufacturing process and that all procedures are guided by best practice.

This results in enhanced customer satisfaction, making certain that when a

pharmaceutical product reaches a consumer, it meets or exceeds the level of
quality they expect. At the same time, it also improves employee morale and
accountability within the pharmaceutical industry—helping to avoid unsafe
working practices, highlighting hazards, and putting their responsibilities into
the bigger picture—which means that the manufacturing and drug
development environment are in the ideal condition for productivity.

In short, QA is vital for continued competitiveness within a dynamic and fast-

paced market where consumer and healthcare demands rapidly shift. By
establishing a trustworthy reputation, pharmaceutical organisations can
create brands and products that people want to buy and use.

Quality Control

So, what about quality control in the pharmaceutical industry, in that case?
As we’ve already mentioned, it’s not really a case of quality assurance vs.
quality control, and both are required within the drug development and
manufacturing environment to ensure patient satisfaction and a high level of
safety.
Quality control is, in one sense, the “other side of the coin” to quality
assurance within the quality management workflow—where the quality
assurance framework acts as a proactive guide for companies to follow to
ensure procedures are safe and efficient, quality control instead guides the
reactive inspection of medications and other products to ensure that they’re
meeting the standards that have been formalised during the QA process.

In short, QC and QA have a symbiotic relationship, with one informing the

other and the advantages of one not cancelling out the other.

The Advantages of Quality Control

The advantages of quality control are numerous, from helping to increase the
efficiency of processes during the manufacturing stage to identifying areas
for urgent or planned improvement, helping to streamline operations and
enhance productivity—and, therefore, profitability.

Without quality control in the pharmaceutical industry, the metrics,

processes, and procedures set out in any QA frameworks would be
untrackable, meaning that business leaders and professionals alike would be
unsure if they were meeting the targets that they and their regulatory bodies
had set out.

If QC is conducted early in production, it can help to highlight defects before

products make their way to consumers—reducing waste and avoiding the
potentially costly risk of recall or even litigation.

Quality control helps to guarantee that professionals employed across the

production and manufacturing environment always keep quality in mind
since their work will be inspected. This helps a pharmaceutical organisation
understand where weaknesses and skills gaps may lie in their workforce and
offer training, learning, and development to assist in resolving issues as they
arise.

Much like QA in pharmaceuticals, QC is a vital part of the puzzle in ensuring

that products exceed the standards expected by patients, healthcare
providers, and regulatory agencies alike, building trust within the industry
and improving the company's general reputation within public and
professional circles.

Quality Assurance vs Quality Control: At a Glance

As we hope to have made clear, it’s not really a case of quality assurance vs
quality control, but rather a case of quality assurance and quality control.
Here are the advantages of quality control and assurance at a glance:

The Advantages of Quality Assurance The Advantages of Quality Control

Enables the proactive avoidance of
costly and dangerous faults
Enhances customer satisfaction
Improves employee morale and
accountability through a safer
pharmaceutical environment
Offers organisations a competitive Lends itself to a culture of learning and
edge in a rapidly fluctuating and
litigious market
Increases brand and product
reputation and trustworthiness
Increases process efficiency and
streamlines operations during
manufacturing
Allows for tracking and evaluation of
metrics set out in the quality assurance
framework
Early defect detection stops faulty
products from reaching consumers and
healthcare practitioners
development by highlighting
weaknesses
Contributes to the reputation for
quality set out in the QA framework

If you’re interested in learning more about the specific work that QA and QC
professionals do in the industry, see our recent guide on How to Become a
Quality Assurance Manager in Pharmaceuticals for expert insights into the
day-to-day duties, responsibilities, and qualifications expected of these
individuals.
How QC and QA in Pharmaceuticals Works
Pharmaceutical quality management is a growing market, expected to
expand to a global value of $9.69 billion by 2027 from its current value of
around $6.95 billion. As we begin to lead longer lives—some of which is likely
to be in sub-optimal health—the role of QA and QC professionals in ensuring
the medications we need to remain free from illness will continue to be vital.

Now that we’ve understood the debate around quality assurance vs. quality
control, we can closely examine how the process actually works within the
pharmaceutical industry.

QA in Pharmaceuticals
As we’ve mentioned, QA is a long-term process covering the entire
development cycle, from ideation, research, and development all the way
through to regulatory approval, storage, and logistics. It’s focused on
preventing issues that can harm patients, business reputations, and the
employees working for a pharmaceutical firm, ensuring that products and
production processes are as risk-free as they can possibly be.

Quality assurance frameworks are often created as a set of standard

operating procedures (SOPs) that align with the ISO 9000:2015 principles on
quality management systems. In short, these ensure:

• Pharmaceutical organisations seek sustainable growth through the

implementation of a robust quality management system
• Customers and healthcare practitioners can have confidence in a
firm’s ability to provide consistent and safe products that conform
to their established requirements
• Businesses can meet demand by having confidence in their supply
chain and logistics processes
• Organisations can improve communication around quality by using
a “common vocabulary” when they’re discussing matters of quality
management
• Training, learning, and professional development in quality
management can be provided to employees and business leaders
alike

QA in pharmaceuticals is process-oriented and focuses on preventing quality

issues before they ever arise—of course, it’s possible and even likely that
nothing can be done to stop all quality issues since humans and the
manufacturing environment alike are fallible, which is where QC comes into
play.

QC in Pharmaceuticals

When it comes to the quality assurance vs. quality control relationship, QC is

certainly on the short-term side of the equation, ensuring that costly
mistakes are avoided, and safety-critical checks are in place at the “end” of
the production process—albeit the checks may well occur at any stage of
manufacturing.

QC ensures that quality issues in pharmaceutical drugs are identified.

Whether they’re safety-critical or will simply harm consumer satisfaction—if,
for instance, a pill that should be able to be split has been manufactured
without a score down the middle—QC ensures that these products meet the
standards set out in a quality assurance framework.

Quality control in the pharmaceutical industry has a number of steps,

including:

• Raw materials testing. One of the advantages of quality control is

that organisations can run QC tests at any stage in the
manufacturing process, with professionals' ability to ascertain the
quality of raw materials before they ever go into production,
minimising waste.
• Mid-process testing. During the manufacturing of pharmaceutical
drugs, samples will be taken and tested to ensure that the
organisation’s stringent guidelines are being met.
• Tests on the finished product. Before being sent for storage,
shipping, and eventual distribution to the end consumer, tests will
be run to again ensure that the guidelines set out in the quality
assurance framework are satisfied.
• Stability testing. Therapeutic drugs must be stable over time and
not degrade under normal conditions unless otherwise indicated—
in the case of vaccines which require cold chain management, for
instance—which quality control in the pharmaceutical industry
helps to ensure.
• Traceability. One of the advantages of quality control is that all
samples and drugs tested within the process will be traceable and
accounted for, with accurate test records kept for consumers,
healthcare providers, and regulators able to access this information.

The steps taken to ensure quality control in the pharmaceutical industry are
vital to ensuring that organisations do not open themselves up to the risk of
reputational or financial damage—with a recent drug recall by Johnson and
Johnson losing the company an estimated $600 million by some estimates—
and maintain a high level of safety, ensuring that consumers and the
healthcare industry at large can trust their products and hold them in high
regard.

Quality Assurance vs Quality Control: Key

Takeaways
The ongoing discussion surrounding quality assurance vs. quality control in
the pharmaceutical industry underscores their distinct but interdependent
roles. Whilst QA in pharmaceuticals takes a proactive stance, focusing on
preventing defects and mitigating risks, quality control in the pharmaceutical
industry plays a crucial reactive role in ensuring that raw materials and
finished products meet the standards established within an organisation’s
quality assurance framework.
The advantages of quality control are clear, from increased process efficiency
and the identification of areas for improvement to its contribution to
streamlined operations and greater profitability. QC serves as the vital bridge
between established quality standards and the actual inspection of
pharmaceutical products, detecting issues early in production to reduce
waste, avoid costly recalls, and minimise the danger of litigation.

Together, QA and QC form a symbiotic partnership within the

pharmaceutical quality management system. This approach enhances
customer and healthcare practitioner satisfaction, helps businesses maintain
a strong industry reputation for safety, and keeps organisations competitive
in a rapidly evolving market.

In this dynamic landscape, embracing both QC and QA in pharmaceuticals is

essential for building trust with consumers, healthcare professionals, and
regulatory agencies alike, ultimately ensuring success and profitability.