Is your pharmaceutical company making headlines? Most businesses can survive a quality glitch or two (or even three), but when “Big Pharma” messes up, it makes the national headlines
News outlets are eager to talk about health problems and deaths that are caused by failures in pharmaceutical manufacturing, supply lines, or product testing. They are looking for problems and ready to expose your dirty laundry.
Seemingly small problems like product packaging glitches can have widespread impacts and receive an abundance of bad attention in the media.
Even large manufacturers aren’t immune to pharmaceutical quality assurance problems.
For example, Apotex had to issue a recall this year for packaging defects that could result in unintended conception. Birth control is typically packaged with 21 days of active pills and seven days of placebo pills that are meant to be taken in a specific order.
Apotex had to issue a recall when their pills suffered packaging glitches such as being off by one day, missing pills in the blister packs, and packages without placebos that had 28 days of active pills instead.
The lack of quality control resulted in women being without contraception — and the company facing potential lawsuits.
What’s alarming is that this isn’t the first time the company had to issue a recall for birth control due to quality issues that rendered it ineffective for the single purpose it’s designed for.
The good news is that you can learn from their mistakes and avoid repeated quality control issues in your own production lines. Take the time to learn these warning signs that may indicate you need pharmaceutical quality assurance consulting.
7 Indications You Need Pharmaceutical Quality Assurance Consulting
As an enterprise quality management system (eQMS) platform provider for pharmaceutical startups and scale-ups, we work with a lot of companies that are building quality-driven cultures in their organizations. They often come to us because they initially picked an eQMS that was either built for big pharma and offered the wrong features or wasn't designed to help them meet the relevant pharmaceutical regulations.
If your pharmaceutical company has an eQMS that isn't a good fit, that may be part of the problem; and we invite you to give ours a look.
But, there may be other signs that you need more than just a pharmaceutical eQMS training for your team, like online pharmaceutical quality assurance courses. You might require the help of an experienced quality assurance consultant. Here are seven indicators that a consultant may be a good option for you.
Consumer Confidence Is Wavering
Your consumers are the backbone of your success. You have a complicated purchase process with five separate entities that must all be in agreement before you can make a sale. The FDA has to approve your product, doctors have to prescribe it, pharmacies have to stock it, insurance companies have to cover it, and finally, people have to buy and take it.
If you experience a loss in confidence in any of those five entities, you will feel it.
Some key indicators that you’re losing consumer confidence include:
Indicator #1. You Are Losing Market Share
You might have been the top dog in your market when your product first was released, but now your competitors are taking over and pushing you out.
There are many reasons that you might lose market share. These include:
- Doctors choosing not to prescribe it.
- Pharmacies choosing not to stock it.
- Insurance companies choosing not to cover it.
- Consumers choosing not to buy it.
Indicator #2. Consumers Are Leaving Bad Reviews
Bad reviews are a pretty obvious indicator that your consumer confidence is slipping. Customers can be very vocal about your products and share their opinions and experiences with others.
They may use sites like AskAPatient.com to share their opinions. You need to regularly monitor the relevant consumer review sites to stay ahead of problems.
Indicator #3. Too Many or Too Few CAPAs
Most pharmaceutical CAPAs are the result of feedback from patients either in trial phases or after the product has been released to the market. When symptoms are observed or communicated, a process for quality control using corrective and preventative actions is initiated to find the root cause and prevent further problems.
Symptoms are a normal occurrence in the pharma marketplace. If you aren’t experiencing a regular flow of CAPAs, then it’s likely you have a problem in your CAPA reporting procedures.
However, if your quality systems aren’t functioning properly, you will see a higher-than-normal level of CAPAs and should investigate further as well.
Indicator #4. The FDA Is on Your Back
You might fail to notice your quality issues, but there’s a good chance that the FDA is paying attention. They know these warning signs even if you don’t, and they can be quick to act if they suspect that you have an issue.
If you find yourself “being harassed” by the FDA with letters and audits, there’s a good chance that they have a reason to be wary about your processes. Your pharmaceutical compliance issues aren’t going to fix themselves, and it’s time to get proactive.
Your Internal Systems Aren’t Set Up Properly
Your consumers may be a good indicator that you need to get some help, but you should also turn your examinations inward. If your systems aren’t set up properly, then you could be sabotaging yourself and not even realizing it.
Are you suffering from any of these indicators?
Indicator #5. Your Paper-Based Systems Are Outdated
If you are still using paper-based systems for quality control, then you are going to find yourself regularly facing quality issues. It’s time to make the switch to a pharmaceutical quality management system software platform.
It can be easy to think that paper systems should be able to meet all of your requirements. After all, software systems are relatively new in the history of manufacturing pharmaceuticals. Paper did the job for years and years.
However, the issue lies with assumptions.
Times change and the powers that be assume you have access to certain things in today’s world. For example, teachers used to give students the option to turn in hand-written or typed essay assignments. Now, they require typed essays because the assumption is that all their students will have access to a computer to type up their work.
Likewise, the FDA assumes that you have the ability to use a digital quality management system. That system will meet certain requirements and enable you to have much better documentation and tracking than a paper-based system. Therefore, the FDA can make their requirements stricter because your eQMS software will give you the ability to meet them.
Trying to meet stricter requirements with an outdated paper-based system is an exercise in futility that costs you more in the long run. We've written a guide to help you make the transition from paper-based systems to an eQMS as smoothly and effectively as possible. You can access it instantly here.
Indicator #6. QC Doesn't Inform QA
What is Quality Control (QC)?
Quality control is responsible for making sure that all quality requirements are being fulfilled in your full production lifecycle.
What is Quality Assurance (QA)?
Quality assurance is responsible for communicating to stakeholders that the requirements are being fulfilled.
You might already be seeing where potential problems might pop up if your QC department and your QA department aren’t communicating.
Consumer confidence falls and quality issues slip through the cracks when your QA department isn’t up-to-speed with the goings-on of the QC team. QA may be telling everyone that “everything is great” when the reality is that they don’t know because they aren't talking with the QC team.
Managers may not be addressing issues with quality because the QA team says there aren’t any to address and the cycle goes on and on. You need to close the communication loop and bring everyone to the same page on your processes.
Indicator #7. You Aren't Doing Internal Audits
You shouldn't wait on a regulatory body to come knocking. You should be regularly reviewing your own processes and conducting your own internal audits.
If you can’t pass an internal audit, you can’t hope to pass an FDA audit. Your processes should have a system of built-in checks and balances to help avoid quality control issues before they happen.
Is it Time to Seek Help?
You don’t have to spend countless hours correcting issues, mitigating PR disasters, and fighting the red tape. You can be proactive and use quality control as a platform to propel your brand and products.
The right pharmaceutical quality assurance consultant can show you how to maintain a state of audit-readiness using an eQMS system that will help you consolidate, track, and train.
Download our guide to developing The Perfect Quality Assurance Plan for Pharmaceutical Companies and start making a positive change in your processes today.