Common Compliance Mistakes That Can Get You in Trouble with the FDA

Common Compliance Mistakes That Can Get You in Trouble with the FDA

Specific laws guide companies in every sector. Compliance with those laws aids effective manufacturing and keeps customers safe, especially in the pharmaceutical and biotechnology industries.

Since these industries focus on human health and patient outcomes, adherence to health and safety regulations is crucial. Therefore, pharma manufacturers must watch out for common mistakes equating to non-compliance.

In this blog, we will outline common compliance mistakes and how to escape them through digitization. Let’s dive in.

5 Common Compliance Mistakes

At times, pharma and biotech industries defy regulatory compliance for pharmaceutical products by error. This error could cause the FDA (Food and Drug Administration) to raise an eyebrow at them. Here, we shall discuss six common compliance mistakes pharma manufacturers often make.

1. Poor Documentation

Poor documentation practices include non-compliance to SOPs (Standard Operating Procedures), poor correction practices, inconsistent documentation, etc. Regulatory bodies expect an impeccable GDP (Good Documentation Practice) from pharmaceutical industries.

Compliant GDP requires the highest degree of data integrity while collecting data, registering & commercializing pharma products. It is essential that data across the manufacturing floor is appropriately captured and stored. 

Common records found in pharmaceutical and biotech processes include equipment use-logs, logbooks, forms, cleaning records, checklists, standard operating procedures, technical transfer reports, and more. Mishandling of these documents and records can get them in trouble.

2. Weak Investigations

Thorough checks must be conducted on pharmaceutical products, across all stages of a manufacturing process. Careful consideration must be made toward the quality of the checks and the impact to the process. Thorough investigations and procedures must be in place, yet weak investigations can have a serious impact on the quality of the final product. Regardless of the stage of manufacturing, drug discovery & development, pre-commercial production, and commercial production, quality investigations are critical.

3. Supply Chain Issues

Getting finished goods to wholesalers, retailers, and the final consumers can be a pain for manufacturers in the pharmaceutical industry. The primary issue is that the link between the manufacturer and the patients (hospitals, pharmacies, shelters, etc.) can be fragmented.

Some of the issues that contribute to the damage of this distribution network are lack of appropriate checks, lack of communication, and damage to records. Often, paper-records shared between organizations are prone to damage or loss. 

4. Failures in Laboratory Controls

Laboratory control is a form of quality control that requires compliance in pharmaceutical industries. Laboratory control is the system set to mitigate risks in labs & ensure accuracy, reliability, and promptness of lab results.

Creating a laboratory quality management system will avert these issues for your organization. A laboratory quality management system generates an effective and result-oriented lab operation.

5.Improper Cleaning/Sanitizing/Maintenance

Room cleaning logs and records are critical for compliance. Although rigorous cleanings and sanitizations are performed, activities are still too often recorded on paper. Paper records are prone to damage, or human error and handwriting issues. 

Failure to properly document and store these records are sure-fire ways to get into hot water with the FDA. It is essential to accurately record all cleaning and production activities and store them for retrieval and review. 

How to Escape Compliance Mistakes Through Digitization

Digital transformation can help any pharmaceutical or biotech organization make strides in FDA compliance. 

Digitization helps a lot with manufacturing and supply chain management. A digitized supply chain will address the spread of counterfeit drugs, the increasing numbers of supply chain partners, and quality control.

Moreover, companies will address these issues through improved operational processes, end-to-end supply chain integration, and real-time decision-making. When these solutions are in place, pharmaceuticals and life science & biotech will have nothing to worry about regarding pharmaceutical compliance. The use of digital technology will also make companies more responsive.

In summary, compliance in pharmaceutical industries will continue to be an issue if those operating within it do not pay attention. Being mindful of pharmaceutical compliance will require companies to understand what regulatory bodies expect from them. Hence, they can adhere to the requirements and not make mistakes that can lead to penalties or a ban.

Digitization is the way to go, and that is why we provide paperless record solutions at Opstrakker. Our digital solution will help you eliminate errors and maintain strict pharmaceutical compliance, improving your brand image. Request a demo today, and let’s kick it off from there.

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