The need for ISO certification for the pharmaceutical industry in 2023

Heena Sharma

Heena Sharma

One of the largest industries globally, the pharmaceutical industry rakes in billions yearly. But since it does cater to the well-being of such a massive population segment, the industry guidelines are stricter than most.

ISO certifications for the pharmaceutical industry are essential to establish credibility and build trust. ISO certification helps companies stay compliant while managing their operations. 

To help you understand the process of ISO certification for the pharmaceutical industry better, we’ll cover the following:

Table of Contents

Introduction to the Pharmaceutical Industry

Developing and manufacturing drugs and medications are the primary objectives of the pharmaceutical industry. To streamline the different processes, the industry is segmented into various fields such as research, development, etc. 

The production of drugs is done in a manner that aligns with the regulations set by government agencies such as the Food and Drug Administration (FDA) in the United States. Majorly, the industry as a whole develops most drugs to combat:

  • Musculoskeletal disorders
  • Cardiovascular diseases
  • Bacterial, viral, fungal, and parasitic infections
  • Metabolic disorders
  • Central nervous system disorders
  • Respiratory diseases

When developing these drugs, having an ISO certification can do wonders. We’ll tell you why in the next section.

Importance of ISO Certification for the Pharmaceutical Industry

As we all know, this industry is responsible for protecting the health of our society. Since the stakes are so high, the need for popper regulation and maintaining a standard quality becomes even more vital.

Each step of production of these products requires strict guidelines that should be followed to ensure the safety of the people who consume the drugs. This is where the International Organization of Standardization (ISO) comes into the picture. 

ISO for pharmacy creates and documents standards specially developed to maintain the quality and safety of the products. Therefore, the need for ISO certification in the pharmaceutical industry is constantly rising. 

So getting an ISO certification is the best option if you’re looking to kill two birds with one stone – proving your credibility and staying ahead of your competitors.

ISO Standards Best Suited for Pharmaceutical Industry

Now that you know how vital ISO certification is for the pharmaceutical industry, here are some of the primary certifications that can help you stand out:

ISO 9001

The most popular ISO certification, ISO 9001:2015, has been developed to implement quality management systems within an organization. It is not just restricted to the pharmaceutical industry but can be applied to any industry. The standard emphasizes ensuring pharmaceutical products’ quality, safety, and efficiency and the processes associated with their development.

ISO 14001

This standard checks the harmful impact of business activities on the environment. This certification helps pharmaceutical companies establish that they’re taking the necessary measures to minimize any harm that might be getting incurred to the environment owing to their activities. It proves that they’re following environmental laws.

ISO 45001

This was introduced to ensure that a workforce’s safety and well-being aren’t compromised to increase productivity. This standard implements the Occupational Health and Safety Management System in an organization to prevent any occupational safety risks.

ISO 50001

The goal of this standard is to help organizations decrease their carbon footprint. So if you, getting an ISO 50001 certification proves your company is actively taking steps to reduce waste and use energy resources efficiently. By doing so, you also cut down on costs. Not to forget the competitive edge it gives you.

Benefits of ISO Certification for the Pharmaceutical Industry

Considered the backbone of the economy, the pharmaceutical industry is also famous for causing irreversible environmental damage. ISO certifications act as shields that keep them from doing activities that might have such a negative impact.

Some other advantages of ISO certification for the pharmaceutical industry are:

  • ISO for pharmacy makes sure that the decision-making is being done based on any risks that might come up. Further, it also ensures that you’re well-prepared to handle and prevent such threats.
  • Increasing the upper management’s involvement helps the management system’s more effective execution. 
  • ISO certification for the pharmaceutical industry leads to smoother supply chain management within different organizations under its umbrella.
  • As it proves an organization’s credibility, ISO certification helps companies produce and manufacture only premium and safe products without compromising customer satisfaction.
  • ISO can help you safeguard your employees against any potential issues that may come up during the manufacturing process.
  • With the help of ISO 50001, you can make your business more cost-efficient and increase your savings.
  • By getting ISO certification, you’ll prove to your customers that you’re using only the best practices when developing and manufacturing drugs and medication.

Steps Involved in Getting ISO Certification for Pharmaceutical Industry

To help you get a better understanding of what the process will look like, we have listed the steps below:

  • The application and contract are processed.
  • The Audit team is assigned the review work.
  • Documentation is reviewed. 
  • The Certification Audit Independent completed the review. 
  • Finally, the certification comes through.
  • Once that’s done, the surveillance audit takes place.
  • Lastly, the reassessment happens.

Therefore, if your company is a part of the pharmaceutical industry, getting ISO certification(s) can only help you grow more, prosper, reduce costs, and, most importantly, serve your customers well. The benefits only go up in number. But if you’re still unsure and want to know more about ISO certification for the pharmaceutical industry, just reach out to us!

About IS Auditr

IS Auditr is a team of experienced ISO auditors. They offer several end-to-end services, provide certifications to businesses and help them enhance their day-to-day operations. If you want to know more about our services, contact us.

Heena Sharma

About Heena Sharma

Heena Sharma is a successful entrepreneur. She is the founder of IS Auditr Inc, is a bootstrapped business that provides affordable ISO services for businesses.

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