When it comes to making sure that pharmaceutical manufacturing complies with regulatory requirements, the size of the company can make a difference. Large companies span their operations across multiple sites, which makes it difficult to implement and maintain uniform procedures companywide. But enlisting the expertise of FDA compliance leaders in the pharmaceutical industry can ensure that procedures are implemented and followed, helping to avoid problems that spark regulatory concerns.

Modern technology helps pharmaceutical manufacturers monitor and maintain their operations. But company culture can be more problematic for compliance at larger companies, Simon Jacobson, a research analyst for manufacturing operations at AMR Research, tells Pharmaceutical Manufacturing. Besides having operations spread out across multiple locations, large companies have cultural silos that divide departments and workers, preventing them from working together to identify and address manufacturing problems. This division is less evident at smaller manufacturers, where workers can easily collaborate at a single site. Large companies can overcome their cultural divisions, but Jacobson says doing so calls for a more systematic approach. For example:

  • Establish formal and process requirements across sites. Jacobson says that when processes become inconsistent across multiple facilities, problems can arise, possibly causing managers to address the same problem at multiple sites.
  • Implement corrective and preventative measures early. If you wait until a formal complaint or failure, it might be too late, Jacobson says.
  • Track best practices. If a solution works at one facility, implementing it at other sites can help head off problems that might arise in the future. A prescribed workflow and system to document problems can track the progress of corrective actions and serve as a record for the company, Robert Fetterman of Technical Business solutions tells Pharmaceutical Manufacturing.

Having formal procedures in place can help a pharmaceutical manufacturer identify problems, find solutions, and deploy those solutions companywide so that similar problems can be avoided in the future. To learn more about how to implement formal and comprehensive practices across drug manufacturing sites, contact us.