5 Pharma Compliance Mistakes to Avoid

The pharma industry must meet stringent regulatory and quality requirements. These five mistakes can hinder compliance efforts, and result in a failing inspection. Here are tips on how to avoid them, and ways digitization can help safe, effective products get to market quickly!

No Quality Unit

Whether the pharma organization has a quality unit (QU) is only part of the issue. The issue is QU empowerment. If the QU is not empowered, and management can overrule a quality decision to reject product, the company essentially has no QU. Surely, the QU can achieve a balance between business needs and quality needs, and this balance weighs the risks to public health, customer needs, and company goodwill. Certainly, such tough decisions need to be documented to demonstrate QU’s rationale for the decision. A digital quality management system (QMS) won’t automate the QU, but permissions embedded in a digital solution ensure that only authorized individuals in the QU can authorize a batch release, and all electronic documentation can be stored in a central location.

Poor Documentation Practices

Some might complain that the QU is comprised of “documentation police,” and, yes, the documentation burden can become frustrating. To ensure documentation is generated properly the first time, it is vitally important to have consistent good documentation practices and data integrity training for all employees who work with pharma quality records.

By now, everyone in pharma quality industry should know what ALCOA stands for (attributable, legible, contemporaneous, original, and accurate). A digital QMS for pharma can force the actions necessary to properly document each of the steps. Furthermore, an electronic system can help facilitate better documentation through the review-by-exception workflow, which results in speedily, well-documented batch documents.

Weak Investigations

When you mess up, fess up. Investigations are a pharma company’s way of demonstrating that their top priority is a commitment to integrity. Sometimes pharma companies become so concerned with data integrity, it amounts to no integrity at all; and this is especially unfortunate because it also represents myriad lost learning opportunities. Companies that punish nonconformities create incentives to hide mistakes, rather than to bring them out in the open and fix them. When an organization commits to integrity, failing or nonconforming products and/or processes are treated as an opportunity to make a performance improvement and this leads to higher quality standards for their pharmaceuticals, and better results for consumers.

Investigations that fail to address the root cause are ineffective, and lead to the same repeated problem, over, and over again (redundancy, get it?). Quality management software has investigation documents that provide prompts for entry of the correct information to result in a thorough investigation, by employing required fields in an electronic form, so investigations include comprehensive, accurate information.

Failure to Perform Periodic Reviews

Annual product reviews are required per regulations, but periodic validation and continued process verifications are equally important. It’s great to know that a system is validated and in control, but it’s better to ensure that your validated, in-control process didn’t fall off-kilter. In the same way that It’s important to periodically visit the doctor to make sure everything is fine, it’s also important to review your quality management systems periodically too.

Poorly performing processes sometimes result in dangerous pharmaceutical products. Quality management software can prompt periodic activities by populating a calendar in the system, so you will never miss your dates again. Periodic reviews also apply to your selected digitized solution, since validations are needed for computerized systems.

Drug Supply Chain Issues

The Drug Supply Chain Security Act will soon reach its final implementation phase, but so much more is necessary for product safety than track and trace. Supply chain starts from the supplier and runs to the end user. It is therefore vital to quality compliance efforts that raw materials, as well as trade partners fulfill requirements for delivering safe and effective product.

Contract manufacturers play a critical role in product quality, so these suppliers require special oversight. Downstream supply chain partners must not only be properly registered, but it is also important, especially for prescription drug products, to ensure that these partners have undergone product impact assessments. Remember that If a supply chain partner refuses your inspection, it may be time to shop for a new supplier.

Use a digital quality management system for the appropriate tracking of digitally accessible, updateable supplier documentation, and tracking of barcode labels. Supplier files in an easy-to-search repository help companies locate their best-rated business partners for use in future company projects.