Pharmaceutical companies in the market today need to comply with a huge array of regulations –in most regions, manufacturers must follow Good Manufacturing Practice (GMP), as well as Good Documentation Practice (GDP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Companies need to be able to ensure data integrity and product integrity, or else they put patients at risk and face costly regulatory violations – penalties can include not only heavy fines, but also banned products. In addition, the reputational cost of non-compliance can be significant. With that in mind, there are three steps that companies can take to improve regulatory compliance.
Remain up-to-date on regulatory requirements across disparate regions
With many pharmaceutical companies operating, distributing or partnering across country borders, it’s not enough for manufacturers to know local and national regulations. Companies also need to have a thorough and up-to-date understanding of the latest regional and international regulations that are in force, or pending. Because foreign languages, the pace of change and differences between written regulations and actual enforcement practices and timelines make tracking and planning difficult, companies may find it worthwhile to invest in global regulatory specialists.
Provide training to ensure company-wide compliance
Regulatory compliance is only as strong as the weakest link in the company. In order to ensure compliance across the company, staff from lab technicians to the CEO should have an understanding of how their daily jobs affect regulatory compliance. As a best practice, staff should be trained on not just the “what” and “how” of regulatory compliance within their sphere of operations, but also the “why” rationale behind each action to enable a more resilient corporate approach to compliance.
Digitizing operations can also provide significant compliance benefits. As one example, when Fujirebio, a manufacturer of biomarkers, replaced their existing paper-based GMP record system with a digitized solution with integrated workflow, they were able to significantly improve regulatory compliance. Before, the paper-based system was slow and prone to human error. Switching to a digitized system reduced errors and fulfilled the electronic system requirements needed for Fujirebio to maintain 21 CFR Part 11 compliance and the facility’s ISO 9001 and 13485 certification.
As an additional benefit, digitizing the GMP system saved a considerable amount of time. Whereas previously operators had manually logged equipment parameters and reviewed paper logs and charts, now all data is reviewed digitally, meaning data review time shrank from more than 15 hours to just minutes. Overall, the system saves more than 1,100 man hours per year.
To learn more about the benefits of digitizing operations in pharmaceutical manufacturing, read our Fujirebio case study and be sure to join our webinar on the benefits of adopting serialization.
Are you a pharmaceutical manufacturer looking to improve regulatory compliance? Let us know your thoughts in the comment section.