Regulatory bodies throughout the world seek to protect public health and ensure the safety, effectiveness, and security of pharmaceuticals, biologics, and medical devices in their respective territories. Health authorities have established specific regulations and monitoring procedures for each product group.
Apart from the fundamental regulatory requirements, there are also additional important issues to consider, such as language hurdles, numerous data sources from which to extract information, and a lack of understanding of the procedures and technology required. These difficulties lead to concerns such as compliance monitoring, market inconsistencies, inadequate information traceability, late reaction to regulatory changes, product rejection, and even product recalls. Expert experts are needed by pharma businesses with worldwide product coverage to comprehend and manage operations based on region-specific regulatory compliance.
It raises the industry's resource demands and operating expenses. As these agencies continue to update their regulatory criteria to maintain patient safety and product effectiveness, the difficulty multiplies. That being said, in the article let's chalk out the regulatory challenges and identify how the pharma industry is planning to be on par with the evolving regulatory compliances.
Need for Data Management One of the most critical challenges that the pharma industry faces is a large amount of unstructured data and information from various social media platforms and medical literature. They have to skim through the data to monitor the adverse effects mentioned. It becomes nearly impossible to keep an eye on such vast data without the usage of technological solutions. “While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable,” says David W. Husman, PhD, ASQ CPGP, RAC.
Although the need to adopt intelligent and integrated technologies for compliance management is imperative, their usage is still immature in these highly regulated industries. The current usage is limited to job-specific tools, which remain ineffective in the holistic control of the activities. A strategic approach for pharma companies can be to implement a comprehensive regulatory management framework driven through intelligent regulatory platforms. The framework, for example, can help define and monitor product regulatory strategies right from clinical to market extension, and is well-integrated to support global and local regulatory compliance operations.
Laboratory Control and Quality Criteria In 2018, failure of laboratory control was one biggest issue for FDA, and the regulatory body forwarded 127 citations to the pharmaceutical companies identifying them for failed laboratory controls.
Failed lab controls can significantly lower quality assurance requirements. The FDA's cGMP requirements demand the construction of a quality control system to avoid this scenario. However, the QMS can play a decisive role in determining how healthcare product producers implement cGMP rules. It's a framework or organizational structure that maintains product safety and efficacy by maximizing policy and procedure compliance, promoting process efficiency and accuracy, and ensuring product safety and efficacy.
“The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products,” says Joscelyn Bowersock, MS.
Faulty Production records and Batch Review To assess compliance with SOPs, the pharma QC unit must analyze and approve all medication manufacturing and control records, including packaging and labeling records. If there is a discrepancy or failure, the QC is in charge of conducting a comprehensive investigation and compiling a report that contains findings and next steps.
Manufacturers who rely on manual, paper-based batch record systems have limited monitoring capabilities, limiting their ability to follow manufacturing changes, identify quality issues, and respond in real time. Bottlenecks are almost inevitable when tracking information is limited. Manual manufacturing procedures, for example, frequently result in poor deviation monitoring and control, including sluggish identification of essential deviations and a high rate of in-process deviations.
However, Electronic Batch Record(EBR) can deliver fruitful results to the pharma industry. An EBR solution with analytics and in-process dashboards can provide real-time operational visibility and optimization, enabling manufacturers to - gain real-time work-in-progress visibility and traceability into the status of production lines, batches, lots, and operator performance. The EBR can also help to Integrate the recording, assessment, and approval of all deviations throughout the manufacturing process with real-time deviation-tracking tools while helping to seamlessly exchange data, increase data accuracy, and gain a complete picture of production data.
Looking Forward In days to come, Pharma companies, importantly the ones operating in India, will need to realign their quality and compliance structure to conform to the constantly evolving regulatory guidelines. With the FDA and other regulators broadening the scope of compliance requirements, it helps if companies have a holistic approach and make regulatory compliance part of their corporate strategy.
This includes effective training, proper timely communication, periodic reviews, and support from the top management. Companies ought to be proactive in setting up stringent internal controls as part of their commitment towards quality and compliance. Regulators have to focus on aligning country-specific regulatory frameworks to global standards enabling harmonization of standards and help companies drive efficiencies.
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