Bir İlaç Projesinin Düzenleyici Gereklilikleri Karşıladığından Nasıl Emin Olunur: Adım Adım Nihai Kılavuz 

The concept of a pharmaceutical project can definitely sound very intimidating for several industries, and one of the reasons as to why is because these projects must meet the most stringent regulatory requirements, from research and development, to post-market surveillance. What are the steps to follow in order to do so? Find out the details in this guide which will tackle the following pointers:

– The importance of meeting regulatory requirements

– Steps to ensure your pharmaceutical project meets these requirements

– How Canaan can help 

The Importance of Adhering to Regulatory Requirements

In case a pharmaceutical project fails to meet regulatory requirements, even if its catalog of pharmaceutical products is promising, financial penalties, reputational damage, and heightened regulatory scrutiny await. 

There is a reason why vehicles commit to road checkpoints, and so are pharmaceutical projects. Non-compliance may lead to product recalls, legal actions, and even the shutdown of your facility. So, how can you adhere to these requirements? Read on.

Pharmaceutical Project Management 101: Steps in Ensuring Regulatory Requirements Are Met

From GMP Requirements and Compliance Management to FDA Requirements and Compliance Management, businesses running a pharmaceutical facility must go above and beyond when upholding the most rigorous standards to ensure product compliance and patient safety. 

Step 1: Get to Know Rules for Regulation

Of course, the first step to ensure regulations are met is to understand their very framework. It begins with understanding the requirements of authorities.

Businesses should stay updated on evolving rules, implement gap evaluations, and execute compliance programs tailored to jurisdictional requirements, just like operating online casinos.

This important step was what’s missed by GlaxoSmithKline, which was told to pay $3 billion in settlement because of their failure to follow regulatory frameworks.

Step 2: Implement QMS or Quality Management Systems

Just as how business process outsourcing industries implement a robust quality control system, a strong quality management system must be present in every pharmaceutical project. 

Fagron – a company that supplies products and services to professionals and institutions in the healthcare sector in Europe, the United States, Brazil and Argentina – is a prime example of how having a QMS helps. 

The company has QMS in place to streamline and standardize quality processes, which is why it is able to operate triumphantly in its global sites.

This ensures product integrity and regulatory adherence. Remember the following key components when implementing an efficient QMS:

• Control of documents
• Eğitim
• Change control
• Corrective and preventive actions
• Audits and inspections

Step 3: Guarantee the Integrity of Data

Even if a pharmaceutical project is not primarily tech-based, data integrity is still important. Interestingly, the lack of data integrity can cost the world a whopping $2 trillion.

Keeping data reliable is critical for regulatory compliance. It is interesting to note that this step involves defining policies for data governance, system validations to ensure precision, data security or protection against cyberattacks, and data review to correct possible discrepancies. 

Step 4: Conduct Risk Assessments 

It is not only in finance that managing risks works but also in the pharmaceutical world. Your pharmaceutical projects should ensure they comply with regulations by swiftly identifying hazards, analyzing risks, addressing those risks, and constantly monitoring and reviewing your projects.

The U.S. Food and Drug Administration does this perfectly. In one instance, the FDA evaluated the cardiovascular risks associated with long-acting antimuscarinic agents used in the treatment of chronic obstructive pulmonary disease. As a result, potential safety concerns were swiftly identified before it is too late.

Step 5: Stay Informed Always

These regulatory compliance requirements evolve, and so is your industry. Your pharmaceutical project must keep moving and must never be stagnant. 

How Canaan Can Help

Pharmaceutical compliance is beyond being just a regulatory obligation. It must never be done by force, nor must be carried out because it is needed. 

Rather, this is a commitment to quality, safety, and patient care. By following the complete step-by-step guide above, your business can navigate the intricacies of compliance with confidence, ensuring that your revenue flows consistently. 

Kenan is here to help. Ours is a manufacturer of pharmaceutical equipment that are products of the most advanced technology and care for humanity. There is no reason you should doubt the integrity of our equipment as they are crafted following the highest industry standards. For more information and to get started partnering with us, coordinate with our team today.