The ultimate guide to pharmaceutical quality assurance


    It can be a challenge to maintain company-wide dedication to pharmaceutical quality assurance. When you have a product that has the potential to drastically change lives, it’s hard not to do everything you can to get it to market quickly, and it can feel as though the quality assurance (QA) team is slowing down the process.

    However, it’s important that everyone in your company understands how crucial pharmaceutical quality assurance is for the success of your product and the safety of your customers.

    The pharmaceutical industry learned this hard lesson during the thalidomide disaster of the late 1950s. Thalidomide was given to pregnant mothers in the first trimester to help with morning sickness, and, as a result, 123,000 babies died in the womb, and over 24,000 children around the world were born with thalidomide-related disabilities.

    The US was spared from the worst of the disaster because FDA inspector Frances Kelsey was not satisfied that the drug was safe. She refused to approve it for use in the US and persisted in requesting additional clinical trial data and information.

    Thousands were devastated by thalidomide. Drug companies learned how important quality in manufacturing is, and Kelsey’s persistence laid the groundwork for more rigorous drug approval regulations worldwide.

    You can do your part to avoid poor outcomes by having a good understanding of the scope of quality assurance (QA) in the pharmaceutical industry. Ensure that your team understands your QA unit’s responsibilities and expectations and that they work well with all branches of your business.


    What is quality assurance in the pharmaceutical industry?


    Pharmaceutical quality assurance is a critical ingredient of the broader discipline of pharmaceutical quality management.

    In short, it's the bundle of activity performed by pharmaceutical quality professionals to ensure that processes and procedures output safe, effective drugs that are compliant with applicable regulations.

    Quality assurance in the pharmaceutical industry is typically performed as part of the overarching pharmaceutical quality system, or PQS. In this sense, it should be seen as part of the 8 essential elements of pharma quality.


    Quality assurance vs. quality control in pharma


    Quality control in the pharmaceutical industry is often conflated with pharmaceutical quality assurance, but they are different, complementary approaches.

    Where pharmaceutical quality control is largely reactive and product-based, focused on the testing of batches to ensure they meet quality objectives, pharmaceutical quality assurance is a more proactive, process-based approach.

    As a general rule, regulators such as the FDA prefer to see more pharmaceutical quality assurance and less pharmaceutical quality control. Quality control has its place and should always be performed, but the bulk of your effort should be directed at more proactive, assurance-based activity that prevents quality issues arising in the first place.

    Pharmaceutical quality control activities include:

    • Batch inspections
    • Sampling
    • Testing

    While pharmaceutical quality assurance activities include:

    • Auditing
    • Training employees
    • Creating documents like SOPs and work instructions to guide processes
    • Executing corrective and preventive actions (CAPAs) to prevent issues re-occurring


    Pharmaceutical quality assurance touches every phase of the product lifecycle


    Pharmaceutical quality assurance is involved in the planning, system governance, and process of every phase of the pharmaceutical business. QA professionals are trained in current good manufacturing practices (cGMP) to help ensure that your company remains compliant—meaning they’re responsible for defining and executing systems and processes across your company that ensure your goods and services meet all quality, efficacy, and safety requirements.

    QA should be involved in every one of these phases to make sure that the product that gets to each patient is as safe and effective as possible. This means performing process validation at each step, so they can control what’s happening throughout the design, development, and distribution of the drug. If they find an issue, they’ll work to determine the root cause and address it quickly to keep production moving.


    New product planning

    From the very beginning, quality should be at the forefront of everyone’s mind. When you start to create a new drug or therapeutic for a medical condition, you need to have a product quality plan in place that outlines your pharmaceutical company’s mission and goals, along with quality processes or standard operating procedures (SOPs) that each team will need to follow.


    Each step in the product design process should be verified by the pharmaceutical quality assurance team to make sure that the drug will be of the highest quality. Those in charge of design should work very closely with QA professionals to thoroughly document each part of the process so that everyone knows what steps were taken to design the drug and so they can be added to all batch records.

    Prototype creation

    Once the design process is completed, QA will also monitor the creation of prototypes. These are created following the design guidelines and any steps set forth during the product planning. QA will make sure that everything is done within their quality standards.


    QA professionals will test the new drug for drug stability, meaning they assess to see if the drug or any of its components break down in certain environmental conditions. This helps set guidelines on how to store the drug safely and correctly.


    If any part of your drug creation process is subcontracted out, then QA will need to assess those facilities to see if they are following your quality processes to the letter. If they aren’t, your QA team may make adjustments to the production process.


    Before you buy any raw materials or containers for your new drug, QA should step in to verify that every entity involved in your supply chain is operating under the same stringent processes as you are. If the items you purchase to make or store your pharmaceutical product aren’t high quality as well, then your drug and your company could suffer. A low-quality storage solution could mean that your medicine will be compromised in a short amount of time, which in turn hurts its therapeutic effect.

    Process design

    At this step, QA will help verify that the drug creation process is designed correctly and that all involved are aware of their roles in the process. QA’s presence here works to ensure that the therapeutic is assembled properly. If design flaws happen, QA can detect them and adjust the process as quickly as possible.

    Trial production

    Clinical trials are a long, drawn-out process, and creating those trials requires heavy and concerted pharmaceutical quality assurance activity. They need to make sure that the trials are designed and produced following FDA regulations and that every person participating in the trial administration is educated on those regulations. If a misstep is made during clinical trials, it can lose your company both time and money.


    When you are ready to begin producing the drug to market, and it’s been approved by the FDA, QA must still be present at all times. Any hiccup in the production process could mean a setback for your company, so it’s vital to have a proactive QA team there to detect any potential quality and compliance issues.


    Put your marketing materials through QA as well to assure yourselves, and your stakeholders, that anything going out to the public about your new drug presents accurate information and does not misinform. You’ll also want to QA any response you have to complaints or product recalls.


    Storing the drug properly before it leaves your company’s warehouse is important, but so is distributing it. If the finished products are distributed incorrectly, that can compromise its integrity. QA makes sure that the distribution is done correctly and that all standards are met when it comes to keeping the drug at correct temperatures during transportation.

    After-sales service

    Once the drug leaves the pharmacy or doctor’s office, your QA program’s team still isn’t done. They need to follow up with patients to see how the drug is working for them and then bring that data back to the company in case any processes need to be adjusted.


    Create a pharmaceutical quality assurance plan


    A pharmaceutical quality assurance plan will help you provide a foundation for compliant manufacturing systems. It defines how each process should work as well as how each subsystem should integrate to help you consistently produce quality pharmaceuticals.

    Your plan should include seven main components:

    1. Document Control
    2. Training
    3. Deviation
    4. Laboratory OOS (Out of Spec)
    5. Corrective and Preventive Actions (CAPA)
    6. Internal Audits
    7. Management Review


    Related Reading: The Guide to the Perfect Pharmaceutical Quality Assurance Plan


    Build a culture of continuous improvement


    Consistently manufacturing the highest-quality pharmaceuticals isn’t going to be a one-time goal. You won’t simply be able to create a plan, implement it, and then achieve lasting results.

    You will need to implement a culture of continuous improvement throughout your company—from the management team down to the shop floor.

    Continuous improvement allows you to regularly assess your systems, find the flaws, and build a plan for correcting them. You can identify quality issues before they impact your company and find ways to reduce costs and increase production.

    Related Reading: 4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies


    The risks of poor quality assurance in the pharmaceutical industry


    Most outcomes of poor quality won’t be as severe as the thalidomide disaster, but they can still be devastating to your company. You could incur substantial internal costs related to remediation and product failures. You also could face external costs like regulatory action, reputational damage, and a loss of market share.

    While compliance with FDA and other health care regulations is expensive on its own, the cost of non-compliance is much greater. Non-compliance can lead to major legal fines. Pharmaceutical companies have paid billions of dollars over the years for various QA lapses, such as drugs that were misrepresented or promoted as treating a condition that was not FDA approved. According to a recent report, non-compliance costs are 2.71 times as high as the cost of compliance, making it a huge risk to implement poor QA practices.


    The role of a QMS in quality assurance for pharmaceuticals


    A thorough understanding of the scope of quality assurance in the pharmaceutical industry must be an integral part of your day-to-day systems, and a priority for your team. From designers to sales and marketing, everyone needs to understand the importance and work toward a quality compliance goal. They all need to have access to the QA process and real-time visibility into what is happening throughout the company in order to work together—that’s where a quality management system (QMS) comes in.

    Note that quality assurance for pharmaceutical creation is not the same as quality control in the manufacturing process—but both do go hand in hand, and both can be monitored effectively within a QMS that provides everything needed to ensure your company’s quality management goals and regulatory requirements are met.

    More and more pharmaceutical companies are embracing digital pharma software tools, like an eQMS, LIMS or PAT system, to ease their compliance burden and make pharmaceutical quality assurance a more integrated, automated activity.


    Lift your pharmaceutical quality assurance activity to new levels


    Good quality assurance in the pharmaceutical industry depends on embracing best practice, keeping on top of regulatory demands, and building a motivated, well-trained QA team around you.

    Visit Qualio's resource center to access a wealth of pharmaceutical quality assurance content, from building the perfect pharmaceutical quality assurance plan to complying with ICH Q8, Q9 and Q10.