Pharmaceutical is one of the industries which have to follow the most strict regulations. It follows strict environmental management, safety, and quality control guidelines. Being ISO certified is one of the most effective ways to ensure that your company complies with these requirements.
For the pharmaceutical industry, ISO certification enhances marketability and ensures that your processes and products satisfy the global standards of excellence. In this article, we will discuss the importance of ISO certification for the pharmaceutical industry, its benefits, and the key ISO standards that are most relevant to the industry.
The pharmaceutical industry works with sensitive products that have a direct impact on human body. As a result, you cannot compromise in maintaining high production standards.
Achieving ISO Certification for your pharma company shows that your business is committed to manufacturing safe, reliable, and of the best possible quality medications. Having this certification upgrades compliance with regulatory bodies such as the FDA (Food and Drug Administration) and increases customer trust.
ISO Certification stands out for your company in a highly competitive and regulated market. In addition, it facilitates entry into global markets where ISO standards are frequently required to incorporate operations.
The International Organization for Standards provides frameworks for almost all types of businesses. Several ISO standards have been developed to comply with the specific needs of the pharmaceutical sector.
Each of the standards covers particular aspects of operational performance and compliance. They provide an in-depth understanding of the demands of this sector. The best ISO standards for Pharma companies are mentioned below.
The most commonly used quality management management standard is ISO 9001. This standard covers all types of businesses, from small to large. It ensures that a company produces products that satisfy regulatory and customer requirements, and its processes are consistent.
ISO 9001 increases product quality, reduces errors, and improves production efficiency. By ensuring the safety and effectiveness of medications, adopting this standard helps protect patient safety.
The primary objective of ISO 14001 is environmental management. It helps pharmaceutical companies minimize their environmental impact through waste reduction, effective resource management, and compliance with regulatory standards.
In terms of the pharmaceutical sector, this standard encourages sustainability and eliminates environmental risks related to drug manufacture. Your company’s reputation can be improved by implementing ISO 14001. It means your dedication to environmental responsibility.
It is important to protect the health and safety of its workforce for the pharma company. ISO 45001 handles this issue. It also attempts to reduce illnesses and injuries related to the workplace.
The ISO 45001 occupational health and safety management standard aids businesses in identifying risks, preventing accidents at work, and improving the well-being of employees. Handling hazardous substances is routine in pharmaceutical environments. That’s why this standard is extremely important.
And when this framework is followed, employees feel safer at work. It boosts their morale and productivity.
The primary focus of ISO 50001 is energy management. It assists businesses in reducing their carbon footprint in the environment as well as consumption of energy. The pharmaceutical business frequently uses energy-intensive technologies. So your company may save a lot of money and protect the environment by implementing ISO 50001 into practice.
And what more? Additionally, it will strengthen your company’s sustainability credentials. They are valuable to both regulators and customers.
These are not the only standards that are suitable for pharma companies. There are some other standards like ISO 27001 (Information Security Management System), ISO 31000 (Risk Management System), etc.
Getting ISO certified will bring several benefits to your pharmaceutical company. Let’s see what:
The ISO certification process for pharmaceutical companies is the same as for other companies. Here I am briefly mentioning the process. For further details, you can check out this article.
To learn more about ISO certification in Bangladesh, you may contact our experts at 01731727172.
The ISO 9001 standard is likely the most important for businesses in this sector. Because pharmaceutical companies place a high premium on quality control and constant product safety.
The cost of ISO certification depends on company size, number of employees, complexity, etc. The approximate cost is 1.5 lakh to 4 lakh BDT in Bangladesh.
Actually, the duration of time it takes to get ISO certified may differ based on the size, complexity, and current management systems of your company. It normally takes 3-6 months.
