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In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content. When SPL format was mandated, it has not only refined the label content, but has also served as an opportunity for organizations to examine and streamline the processes of generating label information.
Despite being such a well-defined format, for over a decade now, manufacturers often find, compiling an SPL challenging. In what way? Some of the most common challenges are listed and briefly discussed below.
- Unreliable source of label content: Unreliable source of label content leads to incorrect labels which when promoted on products end up misinforming the physicians and end-users. Such an implication might lead to product recalls and is hence unacceptable while compiling an SPL submission. Organizations must ensure the label content is from a reliable source and verify it with expert assistance, if needed.
- Lack of Regulatory process know-how: With evolving Regulatory landscape, there is a possibility of alterations in guidance documents and related regulations. Without the right knowledge on such Regulatory aspects, companies may encounter a loop of reworks while compiling SPL. If organizations do not track these changes and implement them on time, the submission might be subjected to the FDA’s rejection. To begin with, organizations must not only keep track of global Regulatory changes but should also ensure they are fully aware of the SPL submission process.
- Legacy software: Before integrating a tool for compliant SPL creation and submission, users should examine if the tool aligns with the FDA recommendations such as 21 CFR Part 11 criteria and Health Level Seven Standards. Legacy tools may not be fully compliant and equipped to meet with process requirements such as request tracking, format conversions (XML to pdf and MS Word), validations, version management, and many other requirements, which if not catered to will slowdown and complicate the submission process.
The challenges listed above are only from the outer perspective of the problem. Stakeholders involved should decode the complete process limitations and address them at the root-level. Enroute, they might have to depend on right Regulatory assistance and a secure and reliable software for creating, validating, storing and submitting an SPL. Be informed and compile compliant and successful SPL submissions.
