Why you should not overlook FDA compliance?

Why you should not overlook FDA compliance? 

FDA or Food Drug and Administration is the authority that checks the products like medicines, nutraceuticals, food, and beverages for any adulteration. Thus, ensuring healthy and safe consumption and utilization for the end-users.  

• It is important, especially for the businesses working in the process manufacturing industry to stay FDA compliant. FDA has laid down a list of principles. It should be followed throughout the product testing, approval and launch to ensure healthy utilization otherwise your product might get recalled.

• You should always stay updated with the FDA rules. With the changing manufacturing landscape, FDA keeps updating the policies addressing the current matter of concern, so that the units can accordingly create safe products. Thus the goal is to make sure that the public is not left vulnerable to any hazard.

• From design validation, quality control management, auditing services, product claim review, FDA compliance mandates everything and you should follow the instructions to the T to stay safe from getting your product recalled or your business penalized with a hefty fine.

• Meeting compliance standards and protocols, means you’re safe from the ire of the audits that happened frequently as recommended by the FDA. Staying FDA compliant will save you from having to pay the penalty, tarnishing your businesses image ensuring that the audit goes smoothly 

You have understood why you should take FDA compliance seriously especially if you operate in the pharmaceuticals industry. Let’s talk about how you can prepare for an FDA inspection, should the need arise: 

Keep the documents, accessible 

Keep the documents that will be required by the FDA inspector, accessible in a single folder or a centralized location. This will thus eliminate any last-minute trouble of running here and there. Some of the common documents that should be there in your inspection binder are- quality control reports, material handling reports, procedures, list of devices, training protocols.  

All the current documents 

You should have all your current documents in hand. If there has been reports of your product failing to adhere by the guidelines previously, keep the recall, correction reports ready. Furthermore, have all the complaints, recalls reports, CAPAs from the previous inspection ready for review.  

Conduct mock sessions 

One of the best ways to prepare for inspection is to periodically conduct mock inspections. This will thus help you identify the loopholes in your operational cycle. You will be able to promptly work on them to fix it. Furthermore, mock inspections are a great way to strengthen your compliance stand and be ever ready for FDA inspection.  

Ingrain compliance culture 

Make sure that everybody in the organization knows, understands and work in a compliant manner. Therefore, instilling a culture of compliance in the organization will ensure that you are FDA inspection ready, throughout the year.  

We, at Tayana Solutions have helped businesses across the process manufacturing industries stay complaint to the latest FDA standards and norms. Our customized solutions will make sure that no matter your business, compliance is the least of your botheration. Thus, you can focus on investing your workforce, resources in attaining the goals.

Reach out to Tayana Solution experts today!