Introduction
Compliance is very critical in the pharmaceutical industry. It is not just about following rules. It is about ensuring the safety and health of people who depend on medications.
When you do not take compliance seriously, you put your company and patients at risk. This blog will discuss three dangerous mindsets that can lead to compliance problems and offer practical solutions to address them.
The "Compliance is a Burden" Mindset
Explanation:
Sometimes, you might see compliance as a burden. You might think that the rules are just there to make your work harder. This mindset can lead you to take shortcuts or ignore important steps.
Impacts:
Seeing compliance as a burden can lead to severe penalties and fines. Regulatory bodies like the FDA have strict rules. If you do not follow them, you can face big fines.
For example, in 2013, a big pharma company was fined $500 million for not following good manufacturing practices (we have not mentioned the name for obvious reasons, you can search the internet to get the name). Such penalties can hurt your company financially and damage your reputation.
Solutions:
To change this mindset, you need to understand that compliance is part of your commitment to quality and safety. Training programs can help everyone see the importance of compliance.
Regular workshops and seminars can make compliance part of your company culture. By involving everyone, from top management to operational staff, you can ensure that all employees understand and value compliance.
The "Compliance is Only for the Compliance Department" Mindset
Explanation:
This mindset assumes that compliance is solely the responsibility of the compliance department. Other departments might think they do not need to be involved in compliance efforts.
Impacts:
Compliance must be a company-wide effort. When only one department handles compliance, there can be communication gaps and lack of coordination.
For example, in 2016, a big pharma company faced issues with EpiPen pricing and regulatory compliance because different departments were not aligned on compliance matters.
Solutions:
You need to foster a culture of shared responsibility. Every department should understand its role in compliance.
Cross-functional teams and regular communication can ensure everyone is on the same page. Training sessions and workshops can help all employees understand their compliance responsibilities.
The "One-Size-Fits-All" Mindset
The one-size-fits-all mindset assumes that a single compliance strategy works for every situation. We might think that the same procedures and protocols will apply universally across all departments and products.
Impacts:
This approach can lead to gaps in compliance. Different products and processes may have unique requirements that a generic approach cannot address.
In 2019, a big pharma company had to recall several products because the same quality control measures were applied to different drugs, which did not account for specific differences .
Solutions:
You need to customize your compliance strategies based on specific needs. Each product and process should be evaluated individually to determine the best compliance practices. Tailored training and specialized compliance programs can help address unique requirements effectively.
How IncepBio Can Help
At IncepBio, we understand the challenges of maintaining compliance in the pharmaceutical industry. We offer a range of services to help companies stay compliant and improve their operations.
- Commissioning, Qualification, and Validation (CQV):
Our CQV services ensure that your systems and processes meet regulatory standards from the start. We help you with commissioning, qualification, and validation, making sure everything is designed, installed, and operates as required.
- Calibration Services:
Accurate calibration is crucial for compliance. We offer mechanical and thermal calibration services to ensure your instruments are precise and reliable.
- Consulting Services:
Our QMS consulting helps you establish a robust quality management system. We also provide third-party audits, project management, vendor management, training services, and FTE support. These services help you maintain compliance and improve overall efficiency.
- Automation Solutions:
Automation can streamline your compliance processes. We help you implement automation tools and techniques that reduce time, costs, and errors.
- Turnkey Solutions:
From concept to completion, we offer comprehensive project management solutions. Our turnkey solutions ensure that your projects are completed on time and within budget, meeting all regulatory requirements.
At IncepBio, we believe that compliance is not just about following rules but about ensuring patients’ highest quality and safety. We are committed to helping you achieve this goal.
Parting Thoughts
Compliance in the pharmaceutical industry is critical. Dangerous mindsets like viewing compliance as a burden, assuming one-size-fits-all, or thinking compliance is only for the compliance department can put your company at risk.
By fostering a culture that values compliance, aiming to exceed regulatory requirements, adopting a proactive approach, customizing compliance strategies, and sharing responsibility across departments, you can ensure your company’s success and the safety of your patients.
IncepBio is here to support you every step of the way with our comprehensive services and expertise.
Additional Resources
FAQs
Compliance means following all the rules and regulations set by authorities like the FDA to ensure that drugs are safe and effective. This includes everything from manufacturing practices to marketing.
Compliance is crucial because it ensures that medications are safe for patients. It also helps companies avoid fines, legal problems, and damage to their reputation.
If a company does not comply, it can face fines, legal action, and damage to its reputation. In severe cases, products can be recalled, and the company can lose its license to operate.
A company can improve compliance by implementing strong training programs, adopting proactive compliance strategies, and regularly reviewing and updating its practices. Working with a consulting firm like IncepBio can also help.
IncepBio offers services such as Commissioning, Qualification, and Validation (CQV), Calibration Services, Consulting Services, Automation Solutions, and Turnkey Solutions to help companies stay compliant and improve their operations.
