Regulatory compliance refers to the process and activities that a company undertakes to ensure that it adheres to all applicable laws and regulations.
Pharmaceutical manufacturing industry is a highly regulated industry that is regulated by different regulatory agencies from drug development to manufacturing and marketing. To ensure the compliance with all regulatory norms, pharmaceutical company needs to have a well-established monitoring system. In this article we understand the key step to monitor the compliance.
What is Regulatory Compliance?Regulatory compliance is the process in which a company follows all relevant regulatory guidelines and standards those are required to manufacture pharmaceutical products. It includes the manufacturing environment, manufacturing process, safety, efficacy and marketing of the manufactured product. Manufacturing companies need to follow various regulatory guidance and regulations. Manufacturing facilities must always be compliant with current updates from regulatory agencies.
Why is it important for pharmaceuticals? Regulatory agencies are responsible for the safety and efficacy of the medicines those we purchase from the market for our treatment. Regulatory agencies monitor the manufacturing facilities to verify that they follow all the regulations to manufacture the quality products. Companies need to follow the regulations very strictly to maintain the quality and standard of the product. These regulatory norms after proper implementation ensure the safety and efficacy of the medicinal products.
Regulatory agencies use different methods to investigate the non-compliance during inspection of pharmaceutical manufacturing facilities. Pharmaceutical companies must have a full proof system to implement all regulations and their periodic updates. Regular compliance monitoring is very necessary to maintain the safety and effectiveness of the pharmaceutical products.
How to Monitor Regulatory Compliance To ensure the regulatory compliance, it is necessary to have a monitoring system. There are many softwares to assist with this but it is also necessary to have a responsible person who has good understanding of the regulations and can keep the track of regulatory changes. Here are some steps those can help to monitor the regulatory compliance.
1. Pharmaceutical industry needs to follow many regulations. These regulations are subjected to change regularly, so it is important to stay updated about new changes. You can do it by subscribing to the newsletters of regulatory agencies like FDA, EMA, ICH, WHO etc. Alternatively, you can subscribe the newsletter of pharmaguideline.com as we always publish the important changes.
2. You should designate a person in your organization who will be responsible for compliance. This person should have a good understanding of the regulatory norms and guidance. He should be able to stay updated on regulatory changes.
3. Develop the procedures and policies related to compliance and these should be strictly implemented. These procedures and policies should be designed to focus on specific areas of weakness and help to the company maintaining the regulatory compliance.
4. Implement a regulatory compliance management system that keeps a track on changes in regulatory recommendations. It is important to make sure that your company follows all the rules and regulations.
5. Train the employees for regulatory compliance. It is important for company to make sure that employees are aware about importance of regulatory compliance and also know the regulatory agencies’ expectations. Conduct training sessions to ensure that all employees are up-to-date.
6. Internal audits are essential for any regulatory compliance program. Conduct internal audits regularly to identify the areas those need improvements.
7. Take corrective actions promptly when required. If ant non compliance is found, it is important to rectify it immediately to avoid 483 or warning letter. Establish a compliance monitoring program to take corrective action if required.
By taking above steps you can ensure that your company is in compliance with all applicable regulatory guidelines. The products manufactured in your facility are safe and effective.
The benefits of monitoring regulatory complianceAs we understand the pharmaceutical companies are required to comply with regulations suggested by regulatory agencies. With this compliance companies can ensure that their manufactured products are safe for the consumers.
There are many benefits of monitoring the regulatory compliance that includes:
1. Avoiding Product Recalls: By closely monitoring and implementing their process, companies can avoid problems like product recalls that happens when product doesn’t meet the standards required by the regulatory agencies.
2. Ensuring Product Quality: By monitoring the regulatory compliance, you can ensure the production of high-quality products as the standards set by regulatory agencies. This improves the safety of the patients.
3. Patient Protection: The main goal of compliance is to safeguard the patients from substandard and ineffective medicines. These high-quality medicines give confidence to patients in their treatment and they also get well very soon.
4. Improving Efficiency: Monitoring regulatory compliance helps the companies to find out the area for improvement that boost efficiency and reduce cost of manufacturing. This saves tine and ultimately money in long run.
The challenges of monitoring regulatory compliance Regulatory compliance is the most important part of pharmaceutical manufacturing. Non compliances are very serious issues that can result serious consequences like financial penalties or product ban. Therefor companies try their best to comply with regulations.
Monitoring regulatory compliance has many challenges. The regulatory agencies are working regularly and the new regulations are being introduced every day. As you can check, FDA publish a new guidance almost every day. It means companies need to update their compliance regularly and also make sure that all employees are informed about the new updates.
Another challenge is for companies those are operating globally because they need the comply with different regulatory agencies worldwide. They required to follow the updates from all regulatory agencies. Failing to comply with local regulations can lead to serious problems like product recalls and product bans.
Regulatory compliance is not only important to avoid legal issues but it is also critical for safety of patient and effectiveness of the product. It is achieved by complying to the good manufacturing practices and other regulatory guidelines.
The steps given above are helpful to achieve the regulatory compliance in pharmaceutical manufacturing facilities. Regulatory compliance helps the manufacturing facilities ensuring the product manufactured by them are safe and effective. This can avoid the costly product recalls and financial penalties that company may face if they have noncompliance.
If you are a pharmaceutical manufacturer or quality professional, you should take regulatory compliance seriously and implement it in your organization. If you face any issues during regulatory compliance, contact us and we’ll help you in resolving the issues.