The pharmaceutical industry is an incredibly dynamic and complex industry to be a part of. It is understandable why this is so- it brings to life new therapies and medicines that help people live long and healthy lives. This industry has solved many life-challenging issues that have threatened humanity and caused enormous loss of life.
When industry works so closely with human life, it is only natural for there to be several stringent compliance regulations that ensure safety and ethics. Over the past few years, there has been a spike in the regulatory assessment in this industry across the globe. It is because of prosecutions and criminal convictions arising due to compliance issues in the industry. This has resulted in auditing across several areas, like clinical operations, manufacturing, patient information and privacy, and even sales and marketing.
When searching for pharmaceutical testing services to work or partner with, it’s crucial to analyze and understand whether they are compliant with their processes and how transparent they are about their operations. You could take a look at Avomeen to understand this better.
Now, let’s see a few common compliance issues in the pharmaceutical industry.
1. Lack of Clear SOPs
A Standard Operating Procedure (SOP) provides clear written instructions on how to conduct specific routine activities at work. The presence of an SOP makes it simpler for everyone to understand and carry forth operations necessary for work to continue. The lack of effective SOPs tends to be a major compliance issue.
Various roadblocks prevent the creation and usage of SOPs:
- Vague Communication
Ambiguity arises if roles and responsibilities are not charted out in the SOP. Employees can perform their jobs better and remain compliant with standards if they understand correctly what is to be done and what comes under their purview.
- Lack of Participation Across Departments
An SOP is not written in stone. It needs to be updated frequently to stay relevant. The creation and maintenance of these documents should not be limited to a specific department. All departments who use these SOPs need to be collaborating and updating them as required so that it remains relevant across all the departments. This would also encourage employees to provide feedback and offer improvements to work processes.
- Complex Language
SOPs should be written in concise and straightforward language. It’s ideal if it gives step-by-step instructions on how to perform specific tasks and explains it without creating more confusion.
Coherent and comprehensive SOPs aren’t just a must for meeting regulations; they also reflect the quality of the company and act as a blueprint for success.
2. Bad Maintenance
Inadequate cleaning, sanitizing, and maintenance observations comprised more than 2% of the total FDA observations in 2018. The FDA Code of Federal Regulations states that utensils and equipment must be sanitized, maintained, and cleaned appropriately to avoid contamination or malfunctions.
Explicit guidelines should be established when it comes to cleaning and hygiene practices. This includes:
- Stating who is responsible for cleaning and providing clear instructions for the same
- Setting a cleaning schedule
- Instructions for right equipment maintenance
- Regular inspection and protection of equipment
- Logs must also be maintained for cleaning activities, and they should be updated with as much importance as other operational logs.
3. Not Using Data Properly
Having access to data in real-time helps to monitor compliance changes and enhance the company’s performance. This is important because, through this, an organization can move effectively to minimize the impact of non-compliance.
But generally, two common hurdles stop an organization from using data well:
Gathering data from old systems can be a hassle. Most of these legacy systems don’t provide correct data, and attempting to integrate new data tends to be complicated.
A lot of organizations lack good reporting systems. To overcome this, they tend to rely on manual reporting systems, but these can have a high volume of errors. It is also not cost-effective in the long run.
Handling compliance needs should be treated with priority, and not doing so can result in dire consequences for the company.
4. Lab Control Failures
For failed laboratory controls, pharmaceutical companies received close to 4% of the total FDA observations in 2018. The laboratory controls must be monitored and maintained well because they provide essential lab data. The raw data can help to understand a range of things- from instrument calibration to an employee’s adherence to SOPs- that can help in arresting compliance issues swiftly.
Being a part of a pharmaceutical company is a huge responsibility because it directly impacts human lives. Absolute honesty with all the regulations and compliances not only improve people’s lives, but it also gives the company an excellent reputation.