This white paper features insight from Deacom, Inc. into the compliance challenges facing pharmaceutical companies today—and recommendations for how drug manufacturers can avoid them. Also featured in this white paper: TEC’s guidelines for developing a compliance strategy, and a detailed checklist for vetting enterprise software solutions to meet regulatory compliance requirements.
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory infractions. Among the violations were production records that lacked second-person verifications, manufacturing procedures without validated processes for detecting and removing drug impurities, and a laboratory computer system without security features—all issues that could have been prevented with the proper controls. Given the size of the US pharmaceutical market, worth more than an estimated $280 billion (USD) last year, these surely aren’t isolated incidents.
The potential costs of such noncompliance have been illustrated by recent high-profile cases, such as a 2002 fine of $500 million (USD) for one drug maker’s cGMP infractions. Violating the Federal Food, Drug, and Cosmetic Act could result in product seizures, injunction, and criminal prosecution with penalties of up to a year in jail and a $100,000 (USD) fine for each noncompliant shipment or act.
So the obvious question is: Why, if FDA regulations are well known and noncompliance is so costly, are pharmaceutical manufacturers still making avoidable compliance mistakes?
The problem for many companies often lies in the reality of running a business within the limitations of systems that have not kept up with the changes of the industry. Many drug development companies are still using a mix of siloed systems, legacy systems, and manual processes—including spreadsheets and paper-based solutions—to manage their operations, according to a 2005 Pharmaceutical Manufacturing magazine survey.
Unfortunately, siloed systems and manual processes make it difficult for companies to enforce process controls, avoid mistakes, and ensure data integrity and security. More than 80 percent of the survey’s respondents did not have systems in place to help users proactively avoid mistakes, for example. Multiple systems and processes capturing a manufacturer’s data can compound the difficulties in ensuring data integrity and avoiding the costly results of noncompliance.
This white paper discusses some of the compliance challenges faced by pharmaceutical manufacturers. It provides guidelines for creating and implementing a sound compliance plan to ensure your company isn’t the next to receive a warning letter. Finally, in support of compliance processes, this report includes a checklist of some of the functionality your company should seek from pharmaceutical enterprise software vendors.