FDA 483 letter can be a big nightmare for pharmaceutical industries.
In 2022, the FDA sent 62 warning letters and 23 import alerts to major pharmaceutical companies. What’s alarming is that form 483 handouts have doubled in 2022. The main reason behind all this is- the lack of quality control management measures.
Let’s explore the issues in quality control management in the pharma landscape.
Quality Control Challenges Plaguing the Pharma Industry
Ambiguous Procedures and SOPs
In the year 2022 itself, the Food and Drug Administration (FDA) issued 161 citations to pharma companies that were not complying with the SOPs. For pharma companies, FDA CFR mandates them to develop written standard operating procedures (SOPs) for process and production control. For these reasons, enforcing a quality management system is important for documenting and implementing SOPs. These SOPs have requirements listed for quality, purity, and drug identity that should be periodically revised and approved by quality control units. Companies need to ensure compliance with these SOPs and maintain records if any operations deviate from SOPs.
Non-implementation of Laboratory Controls
21 CFR stands for Code of Federal Regulations states that “Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans or test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling or drug products conform to appropriate standards of identity, strength, quality, and purity.
Prevalence of Human Errors
For detecting human errors, the challenging part is finding its root cause. Root cause analysis involves identifying multiple factors that result in human error. There are two types of human errors: intentional and unintentional. Unintentional mistakes include:
- Memory lapse
- Lack of skills and knowledge
Intentional mistakes include:
- Failure in completing or performing a task
- Failure to comply with proper procedures
Detecting Discrepancies and Failures
In 2022, FDA has discovered that more than 140 pharma companies have not followed the standards for detecting failures and discrepancies. According to CFR, the quality control units of pharma companies should review and approve drug control and production records like labeling and packaging records, to ensure compliance with SOPs.
Inconsistency in Data Quality
The lack of data integrity has taken a toll on the pharmaceutical industry. Typically, the issue of data integrity stems from poor quality control management, processes, and technology. It’s been also observed that non-compliance with data integrity amounts to high volumes of invalidated results and product recalls. This is why integrating data integrity into the quality management system is a must for both manual and electronic systems.
Grave Concerns of Non-compliance
Non-compliance in the pharmaceutical industry arises due to the following reasons:
- Presence of several global regulations in the pharmaceutical sector
- Differences in pharmaceutical global compliance regulations across geographical regions
- Non-availability to manage and monitor non-compliance
- Improperly defined SOPs and obsolete maintenance management
- Poor equipment and non-adherence to lab controls
Here are three key challenges hindering the auditing process in pharmaceutical industry:
- Automation: Auditors need to learn to deploy technologies like AI, automation, and robotics to ensure efficiency and precision in the auditing process.
- Supply Chain Challenges: Auditing global supply chains comes with a set of obstacles like cultural differences, language barriers, and logistics. Implementing effective auditing strategies will address the core stumbling blocks in the supply chain whilst maintaining its overall integrity.
- Cybersecurity: Digitizing pharmaceutical systems have emphasized the need to safeguard their critical data against evolving cyberthreats. Auditing data security controls is essential to ensure safety, product quality, and company goodwill.
Envisioning towards Digital, Smart Labs- How RPA can Revolutionize the Pharma Industry
According to a recent Bain and Company study, 84% of companies have embraced automation technologies in some way or other, right after the pandemic. Pharma industries, which were once skeptical about adopting automation technologies like RPA and ML, have woken up to the myriad possibilities of RPA. And why not? Here are some numbers to prove why RPA is the hidden goldmine every pharma company should explore:
- RPA-backed microbiology labs have achieved 10 to 25 % of cost savings.
- Automation of chemical labs lead to 10-20% rise in incremental savings
- Minimizing lab lead times by 75 percent.
How RPA Makes Redundant QC Processes a Cakewalk
Handle Clinical Trial Processes
Drug clinical trials comprise multiple repetitive processes like data validation, data entry, and regulatory report submission to auditors. RPA can automate these redundant processes like:
- Patient data entry
- Checking patient records against EHR
- Appointment Scheduling
- Trial File Master (TFM) Management
- Generating clinical trial reports
Automate Compliance Procedures
The COVID-19 aftermath has led auditors to frequently upgrade compliance rules and regulations in the pharmaceutical industries. Enforcing effective legal frameworks for managing drug production and complying with them is vital to the overall health and safety of consumers.
By deploying RPA solutions, companies can maintain compliance by:
- Scraping compliance websites for implementing upgrades to existing regulatory policies.
- Ensuring compliance of internal documents with modified regulations.
- Automate the submission process of regulatory reports to auditors
- Deploying RPA bots develop audit trails
Bolster Inventory Management
When it comes to inventory management, pharma companies encounter challenges in planning for peak seasons and tracking the source of drug or medicine shipments to the consumer.
RPA bots ensure effective inventory management by:
- Automating Order Management Process.
- Automating shipment tracking and invoices.
- Controlling storage and warehouse temperatures based on data secured by IoT devices.
- Sending alerts about drug expiration dates to warehouse managers.
Optimize Supplier Onboarding Process
With RPA bots, automating repetitive tasks in supplier onboarding can ensure total compliance and minimize data entry errors. Apart from this, RPA bots can help in:
- Gathering data from vendor’s records
- Verifying vendor data with different sources
- Detecting discrepancies between procedures and regulations in vendor’s management systems
- Integrating supplier data in the vendor management databases
If that’s not all, integrating remote monitoring and predictive-maintenance capabilities into lab equipment and devices will not only minimize downtime but reduce the dependencies on equipment like chromatographs, isolators, spectrometers, etc. Today, supply vendors are developing smart automated solutions like automated sample-preparation stations, automated microbial-testing systems, remote equipment monitoring and maintenance, and workflow optimization supported by visual support. Also, analytical testing technologies like Raman spectroscopy or Ultra Performance Liquid Chromatography (UPLC) are being built with intelligent automation capabilities for quick throughput.
Crafting a Full-fledged Cloud RPA Strategy for Quality Control
Choose Processes that Need Automation
Pharmaceutical companies need to build a strategic roadmap for RPA adoption. For instance, is the goal of RPA efforts to eliminate risk, maintain compliance, maintain consistent quality control management, or enable efficiency? For creating the first step of the cloud RPA strategy, assess, examine, and prioritize processes that require automation. By evaluating processes from end to end, choose the tasks that need immediate automation and mark the ones that can be prioritized later.
Take this for example. By deploying collaborative software and other next-gen automation technologies, repetitive tasks like sample delivery and preparation can be performed. High-volume testing, for instance, microbial detection in water can be executed online rather than in a physical lab. Automated labs deploying predictive-maintenance technologies can help in managing infrequent tasks like large-equipment management.
Tie-up with IT Partners
Though RPA tools have been made easy to deploy especially for non-technologists, IT will always play a critical role in the RPA strategy. This is because many RPA tool implementations still require a basic integration setup and access to systems that rely on the expertise of IT specialists. This is why the laboratory personnel need to partner with the IT teams to gain support and knowledge in how to build, manage, and deploy RPA bots on their own.
Set up Centers of Excellence
It’s a mistake to assume that RPA should be limited to automating redundant processes only. What we need is its widespread implementation across different lab operations that induces a strong cultural shift. This can be done by setting up an RPA Centre of Excellence. This team will consist of experts who will enable RPA best practices across all end-to-end operations, departments, and workflows. To leverage RPA to its full potential, the Centre of Excellence will lend its continuous support to help the companies reap the full benefits of this technology.
Draft Governance Policies for RPA
A well-rounded RPA strategy should address issues related to data security, privacy, access controls, and development standards. As the scope and nature of RPA technologies broaden, lab professionals may find it overwhelming to deal with these evolving changes. This is why companies should properly communicate these changes to the lab personnel and help them identify areas where automation is/is not required. With a fine-tuned change management process in place, imparting training, upskilling lab employees, and assisting them in adopting RPA tools can really do wonders.
Leverage RPA Monitoring Solutions
The last step usually lays down the best practices for managing, monitoring, and upgrading RPA bots. To elaborate further, it contains information on how the tools have been implemented, their capabilities, challenges, and outcomes. Along with this, a remediation plan should also be created to address and mitigate risks that can result from RPA implementation.
Cloud RPA: A Force to Reckon
While pharmaceutical companies deploy RPA solutions on their existing legacy infrastructures, its time to make the fast switch to the cloud. Think about it, the journey from drug research to its delivery is a very cumbersome and lengthy process. However, by leveraging high-performance cloud computing, technologies can help lab professionals get access to vast amounts of storage and processing tools to conduct large-scale preliminary surveys and organize resources. How?
Cloud RPA tools along with advanced analytics help to assess, handle, and store huge amounts of data and gather insights to optimize drug discovery.
Another thing with the cloud is companies can build or host their own RPA tools. Usually, it takes $5,000 and $300,000 to build a well-rounded RPA system. But with cloud-native tools, you can create, run, and manage scalable, efficient, and compliant RPA technologies, without spending additional costs on compliance and developing it independently.
Listing the Best Use Cases of Cloud-native Pharma Quality Control Automation
Electronic Batch Record Review
By enabling bots to execute batch record review processes, pharma companies consider the information and documentation sourced from different systems to ensure that they are aligned with the operational frameworks. If the bots don’t detect any discrepancies, then the reviews are closed automatically by the bots.
Since huge volumes of data are reviewed and processed consistently in the pharmaceutical landscape, pharmacovigilance is one area that can take advantage of RPA. In today’s scenario, many pharma companies manually handle case reports due to variations and inconsistencies in data quality, structure, and format. RPA can help to automate this entire process, enabling companies to process huge caseloads whilst eliminating errors and ensuring cost-savings.
Trial Master File Management
The trial master file (TMF or eTMF) is a data repository used to record and embed activities involved in a clinical trial. Usually, data entry is operated manually and sometimes when a trial includes multiple contract research organizations, their eTMFs don’t get successfully integrated. Enabling RPA bots can help in integrating and indexing documents in the eTMFs to minimize data processing times. At the same time, combining RPA and optical character recognition (OCR) technologies can bolster accuracy and mitigate errors in the eTMF.
Regulatory Report Submissions
When it comes to regulatory submission process, RPA can accelerate activities like developing records and filing status tracking. This reduces the time to market and process timelines. Along with this, creating RPA-powered workflows can help to comply with new regulations at very minimal costs.
Effective Pharma Quality Control Management System with Cloud4C’s RPA Solutions
Today, C-suits of pharma companies have shifted their gears and are heavily thrusting on RPA for speedy value chain efficiency, cost savings, cash flow enhancements, and higher speed to markets. Cloud4C, one of the leading cloud-managed services providers, accelerates pharmaceutical processes with next-gen cloud RPA solutions and services.
By enabling RPA solutions, we help companies enhance the data consistency and accuracy of each batch and achieve significant cost savings in lab operations. Not only that, it automates repetitive, time-consuming tasks, reduces compliance risks, and minimizes manual interventions. Organizations can not only run these redundant processes faster, but they have even experienced a substantial increase in productivity and a reduction in operational expenses.
With our RPA solutions, pharma companies have gained a 50% reduction in compliance risks and nearly 100% efficiency in data entry and processing and data integration.
To gain information on our RPA solutions, get in touch with our representative or visit our website.