The pharmaceutical industry is expected to grow at an annual rate of 5-8% for the next three years. In just the past five years, a range of new technologies has been implemented to improve healthcare delivery, analytics and drug production. However, with the lingering challenges of COVID-19, the need for creative solutions has become more urgent than ever.
Routine quality assurance in the pharmaceutical industry has faced considerable challenges while adhering to schedules and production timelines and ensuring that quality compliances are maintained while maintaining social distancing and travel restrictions. Luckily, remote collaboration technologies with a unique 360° spatial view provide a solution that prevents the slowdown of pharmaceutical processes during the pandemic and may offer revolutionary benefits for future use.
The importance of QA in pharma manufacturing
If a drug doesn’t work as advertised, patients can experience adverse and life-threatening reactions. To decrease such instances, quality assurance (QA) professionals use various techniques to ensure the safety and quality of the drug.
The objective of QA in the pharmaceutical company is to confirm the safe and consistent production of pharmaceutical products. Quality control and quality assurance in the pharmaceutical industry are required at every step of the drug production process starting from drug research to the sales and distribution of the drug. Now, quality assurance is more critical than ever. In fact, the FDA is considering a system to measure and rate a drug manufacturer’s quality management maturity. This greater demand for quality will benefit companies that can execute a robust system of their own.
How can remote QA inspections help the pharmaceutical industry?
The FDA has conducted remote critical inspections during COVID-19. In addition, they have developed a risk assessment system to help pharmaceutical companies assess cases of COVID-19 and take further steps accordingly.
Apart from preventing the spread of the pandemic, remote inspections in the pharmaceutical industry can provide the following benefits:
- To ascertain that drugs are produced within a safe environment and in accordance with quality parameters as per GMP as well ICH and other similar guidelines.
- Ensure transparency in the pharma ecosystem and evaluate the quality of production and manufacturing sites, and ensure conformity with good regulatory practices.
- The advantages of using these technologies include the ability to resolve problems faster and more effectively, improved use of risk-based thinking, and improved ability to prevent major compliance issues — all of which alone can save millions.
- Further, improved agility in quality processes can significantly reduce the lead time for quality control labs and eventually allow for faster turnaround in product releases.
Due to the global spread of COVID-19, inspections are needed more than ever before. However, there is little opportunity for inspectors to visit pharmaceutical companies. Therefore, COVID-19 has limited travel significantly and requires all individuals to safely social distance and even remain at home in high-risk areas. However, thanks to advancements in remote collaboration technologies, pharma companies can now conduct more high-quality inspections from afar.
How are remote inspections and audits in the pharmaceutical industry conducted?
During the remote inspection process, the pharmaceutical facility is examined through videoconferencing and similar technology. This can provide an avenue for restricted authorization of facilities until the constraints for social distancing are lifted, and a physical inspection can be conducted. In addition, 360° technology, otherwise known as remote presence, can further increase the authenticity of these remote inspections.
Information collected in remote pharmaceutical inspections
The remote pharmaceutical inspection process is carried out to get the following information:
- The physical address of the company.
- Name and contact details of the main contact.
- Regulatory oversight (Has the FDA or a similar authority inspected the facility?)
- Licenses and registrations.
- Inspection history.
- Product recalls.
- Company size and activity.
- Potential risks of cross-contamination.
Processes done in a complete remote pharmaceutical inspection
The inspection is generally carried out through a remote risk assessment, a review of the pharmaceutical quality system (PQS), a remote audit, and a potential on-site inspection depending on the circumstances. Let’s take a look at these processes in more detail.
The initial assessment
During the initial risk assessment, it’s determined if a remote inspection is a feasible option for the pharmaceutical company in question. The inspection history and licenses will be considered during this initial phase. If a remote inspection can enable provisional approval of the provider, then step two can begin.
Reviewing the PQS
In this stage, an expert will examine the PQS to see if it complies with international quality expectations and the Current Goods Manufacturing Process (cGMP) regulations. This stage involves contamination control and product reviews amongst others.
In the final stage, a remote audit is conducted in which verification of the execution of important policies and procedures is examined. This includes a virtual tour of the facility and the examination of quality agreements and investigation reports. Once the 360° inspection is completed, a detailed report is written out detailing the outcomes and suggestions regarding the temporary approval of the pharmaceutical process.
A brief physical assessment may occur at the end of the remote inspection if the most current COVID-19 rulings allow it. Apart from the essential processes, remote inspections using 360° technology can also be expanded to inspect other activities such as stability testing and engineering contractors.
Three ways pharmaceutical companies can still implement quality assurance best practices during COVID-19
Pharmaceutical companies are taking advantage of innovative technologies to ensure they don’t miss out on quality assurance best practices amidst the pandemic.
1. 360° technology for inspections
360° technology involves using a 360° camera to allow users to see more of what’s happening on the other side simply by moving the screen around. Users get a 360° view of the room with this technology instead of a flat video. This technology is at the top of the list because it can provide an immersive live experience for pharmaceutical experts. Through this technology, much-needed services – such as detailed FDA inspections and international meetings – can easily be carried out remotely for quality assurance.
2. Upgrading websites to improve consumer awareness
Pharmaceutical companies are encouraged to upgrade their websites with technology that improves interaction and QA education. By making this change, patients and pharmaceutical professionals can stay connected through digital campaigns, AI chatbots and emails regarding pandemic updates. In addition, this makes it easy to inform clients about the QA protocol followed during the pandemic to make them feel safe using their products.
3. Mobile apps for quick communication
Mobile apps are another great way to assure QA by keeping in touch with consumers and experts. Apps incorporate programs that deliver the most up-to-date news and content regarding the pharmaceutical industry. This efficient communication is integral in case a pharmaceutical product needs to be recalled due to a discovery of potential COVID-19 contamination.
Why is 360° technology better than traditional video conferencing?
Remote inspections are often carried out through traditional video conferencing. However, there is a better solution. With 360° technology, FDA inspectors and pharmaceutical experts can experience being in a real place and interact with people live using easily portable hardware.
360° technology varies from regular video conferencing because it provides more than a singular and static view of a manufacturing facility. Unlike traditional conferencing, this technology allows the user to move around during the call, which provides a live experience that can only be topped by physically being present at the facility. 360° technology creates a world of new possibilities. International auditors can offer their live expertise in remote site meetings as distance and travel restrictions take a backseat and are no longer a limiting factor.
According to Jean-Noël David, Managing Director CDMO North America at SEQENS, “It’s very good to have this 360° view, and it makes a big difference vs. Skype or Zoom. This experience reduces any doubts on their end that we’re hiding things, and that’s a really valuable aspect during business development.”
“Virtual inspections during a pandemic can really help to ensure continuous supply of much-needed drugs, not just for the U.S., but worldwide,” said Thermo Fisher Scientific regulatory affairs manager Monica Commerford. She added, “During the closeout for our recent EMA inspection, the EMA inspector even used the phrase, ‘during the tour.’ It was not qualified with ‘virtual’ or ‘live stream,’ simply ‘tour.’ And we thought this showed that he had the same experiences that he would have on-site.”
Prioritizing pharmaceutical quality and safety with 360° technology
The pharmaceutical industry has always prioritized safety amidst its daily operations, so taking the extra steps to continue this additional vigilance during COVID-19 is feasible – albeit with some complications. As technology continues to advance, pharmaceutical companies bank on using artificial intelligence and computer systems to make their processes more efficient and safer so everyone can collectively benefit from their products. Patients, pharmaceutical IT professionals, and pharmaceutical quality assurance directors and managers alike can carry out their tasks more efficiently through 360° technology.
360° technology is beneficial in ensuring QA and the continuation of FDA inspections so pharmaceutical consumers can continue to enjoy the products and services offered to them without the fear of contamination or the spreading of COVID-19.
Parul Vij Chopra leads the Customer Success Group at Avatour, the only remote collaboration platform designed for site meetings. Her team partners with multiple customers and their respective teams, all of whom deploy Avatour for their unique needs.
Before Avatour, Parul was an Account Manager at PPO Profits, a consulting firm helping Medical Practices navigate strategy for insurance partnerships. She was also General Manager at Refarmed Chemicals, a Swiss pharmaceutical distribution firm. She spent 10 years honing her skills at managing multiple global, complex bio-pharma projects across all therapeutic categories serving global customers, including Asia, Europe, South America and within CIS and Maghreb countries. Parul has deep expertise forging partnerships between pharma material suppliers and clients. She is also adept at navigating complex regulatory requirements across geographies.
Parul has an MBA in Finance and Marketing from ICFAI Business School and a B.A. degree in Commerce with Hons from Delhi University.
Connect with Parul: LinkedIn: parul-vij-chopra-87654a1a