The development and distribution of drugs is a high-risk business - the development and testing of drugs can take a long and need several iterations; distribution and storage need to be in optimum conditions to preserve the effectiveness of the drugs and therapies and be safe for the users. Therefore, regulatory bodies have made the entire pharma drug development lifecycle very stringent, revising requirements periodically and introducing systems and practices to improve the process.
Adhering to the regulatory requirements is essential to avoid receiving warning letters and product recalls, which can affect product reputation and customer loyalty. However, compliance not only puts the company in the right sight of the regulatory bodies but is also beneficial in ensuring the quality and performance of the products, which can boost brand reputation and customer delight. It reduces the cost of quality, improves the bottom line, and shortens the time-to-market, making compliance a business priority.
Understanding Quality Standards such as GMP and GLP
Good Manufacturing Practice or GMP is a regulation promulgated by the US Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. These regulations are mandatory to ensure the safety, purity, and effectiveness of drugs, medical devices, some food products, and blood by manufacturers, processors, and packagers. A proactive approach to ensuring quality-based manufacturing is required to reduce or eliminate the risk of contamination, eros, and mixups. As any compromise on quality can impact user health and safety, noncompliance can lead to recall or seizure of drugs, fines, and even jail time.
GLP, or Good Laboratory Practices, are guidelines established by the FDA for non-clinical laboratory tests and studies. They aim to ensure the safety and efficacy of the product and provide a framework for companies to perform, evaluate, and report non-clinical laboratory studies.
Regulatory requirements such as GMP and GLP address the need for the following:
- Detailed documentation
- Record keeping
- Personnel qualifications
- Sanitation
- Cleanliness
- Equipment verification
- Process validation
- Complaint handling
They provide the framework and allow individual companies the flexibility to identify risks and appropriate controls to mitigate them. Therefore, manufacturers must understand their organization’s unique needs and correctly implement the controls to be compliant.
Challenges in Maintaining Compliance
Traditional, manual approaches limit the capability of pharma companies to meet the GMP, GLP, etc., due to the following reasons:
- Poor Data Integrity: Pharmaceutical records must be accurate, complete, and consistent. In the absence of a robust data management system, there is the risk of data manipulation, data duplication or loss, unauthorized access and breach, data silos, and so on. This can affect decision-making, leading to poor quality of products, processes, clinical trials, and regulatory submissions.
- Poor Supplier Compliance: The pharma supply chain also plays a crucial role in product quality. The quality of inputs determines the quality of the final product, and therefore, robust supplier management systems are needed to ensure they meet the statutory requirements. The manufacturer is responsible for ensuring the robustness of the supply chain and mitigate any risks arising from it.
- Poor Event Reporting Processes: Pharmaceutical companies must report adverse events within a specified time duration, but they often fail to do so. This is due to a lack of visibility and data, which also makes root cause analysis and CAPA difficult. This increases the risk of such incidents rising and continuing to pose a threat to patient well-being, along with non-compliance.
Benefits of Compliance
While these challenges affect the compliance levels of the pharma manufacturers, they also cause other challenges, including:
- Lower Cost of Manufacturing: When companies comply with stringent standards, their processes become more efficient, and there is less non-conformance. This leads to a higher product success rate, minimizing wastage and scrapping or rework. This improved efficiency and productivity lowers the cost of manufacturing. Also, better quality lowers the cost of quality as there are no or minimum recalls and warning letters, penalties, and other litigation and associated costs.
- Shorter Time-to-Market: While compliance may seem daunting, implementing the recommended framework will, in fact, increase efficiency, improve resource optimization, and shorten the time to market. Getting it right the first time will become simpler due to the implementation of proper documentation, training, 5S, and other quality management practices. Reduced rework will also contribute significantly to shorter cycles.
- Risk-Based Approach: One key requirement of most regulatory requirements is a risk-based approach to quality management in pharma companies. This helps with identifying and ranking risks and prioritizing risk management to optimize resource utilization and address critical risks first. This will reduce events, and with greater compliance, the vigilance from regulatory agencies will also reduce, allowing businesses to breathe easier and focus on their core operations.
ComplianceQuest for Improved Compliance in Pharmaceutical Companies
Automation of quality management is key to improving the efficiency of businesses in being compliant with leading regulatory requirements. The cloud-based solution, ComplianceQuest, is built on Salesforce and draws from ISO standards, which form the foundation for most regulatory requirements. Its features enable businesses to inspect and audit their sites and shopfloor periodically, proactively identify risks, implement controls, monitor the effect, document processes, provide training to fill gaps and improve the overall quality of all processes. Being a cloud-based solution, it also provides businesses with integrated data for greater visibility, transparency, and efficiency, improving decision-making.
To know more, visit: www.compliancequest.com.
