CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL) MANAGEMENT SERVICES
Geography: N/A
Type Service: N/A
Background/Client Requirement:
Our client, a U.S. based leading pharmaceutical company, established with a focus on providing affordable, high-quality medications, specializes in the development, manufacturing, and distribution of generic pharmaceuticals for the U.S. market. With a commitment to improving healthcare accessibility, the company focuses on therapeutic areas such as respiratory diseases, HIV/AIDS, Oncology, Cardiovascular, Diabetes, and many others infectious diseases.
They approached Techsol Life Sciences to manage the full lifecycle of Structured Product Labeling (SPL) for its product line, covering new product entries (SPL Creation), SPL Updation (safety updates), and Delisting (product discontinuation).
Project Objectives:
To provide end-to-end management of Structured Product Labeling (SPL) focusing on SPL Creation, Update, and Delisting, ensuring full regulatory compliance with U.S. FDA labelling requirements and HL7 standards.
- SPL Creation: To Create a structured product labeling (SPL) in XML format for newly approved drug, ensuring it meets the FDA’s labeling and submission standards.
- SPL Update: To update the existing drug SPL with latest safety information and labels to comply with FDA standards.
- SPL Delisting: To ensure the efficient removal of a drug listing from the FDA’s Structured Product Labeling (SPL) database.
To deliver a seamless, timely and error-free SPL for the client while minimizing regulatory risk and ensuring that the product’s listing is reflected in FDA database systems.
Techsol Approach:
Project Initiation: Upon contract signoff Techsol Project Manager will provide the brief overview about the project scope, timelines, expectations, and responsibilities.
Gap Analysis: Techsol Regulatory team will perform a detailed gap analysis to identify missing/ required information in the following categories:
- Header Elements: Drug name and details, Version details, Labeller information, Registrant details, Establishment and business operations.
- Data Elements: Drug names, dosage form, Application details, Marketing date, Characteristics, and Packaging Information.
- Contents of Labeling: Information for all required sections, Revised date, IFU (if applicable) and Labels.
XML Based SPL Authoring:
- SPL Creation: The SPL creation process begins with extracting relevant information from the client’s source Prescribing Information Leaflet (PIL). This data is carefully incorporated into designated sections of the SPL, including Header information, Data Elements, and contents of labeling. Depending on the dosage form, additional sections such as Labels, Instructions for Use (IFU), and Medication Guides are completed with appropriate content.
- SPL Update: Updating the SPL content in XML format, including Document IDs, Section IDs, Version Number, Revised date, New labels with existing labels and other content of labeling sections with outdated or new information mainly Warnings and Precautions, Adverse Reactions, Drug Interactions, and Patient Counselling Information.
- SPL Delisting: The product’s marketing status was updated from “ACTIVE” to “COMPLETED.” This update is essential to signify the product’s end-of-life phase, with the marketing end date documented as required by the FDA, typically using the expiration date of the last produced lot.
Validation and Error resolution: Once all necessary data is integrated, the SPL is validated to verify XML compliance. Any XML or structural errors identified during validation are corrected using SPL validation guide to ensure full compliance with labelling requirements.
Final QC: Designated personnel will perform the QC review to ensure all content meets FDA requirements, is free of validation errors, and accurately reflects updated safety information.
QC Process Flow
Approval: Upon completion of internal QC, the final SPL will be shared with the Sponsor for their review and submission.
SPL Management Process Flow:
Challenges:
- Complexity: The standards for SPL are highly complex, demanding precise adherence to specific formatting, terminology, and metadata guidelines. The Validator may face challenges in accurately interpreting and validating SPL data.
- Addition of Images: A significant challenge was managing reference value errors in file, particularly during the integration of images, which needed to comply with specific formatting requirements and section placements within the product.
- Formatting Tables: Another notable challenge was formatting tables, particularly addressing errors such as ‘Attribute ‘width’ is not allowed to appear in element ‘td’ and ‘Attribute ‘align’ is not allowed to appear in element ‘paragraph.’. Additionally, many tables in the product update contained images within the table cells, further complicating the process.
- Section ID Discrepancy: Submission errors due to Section ID either not aligning with IDs in other documents or repeating from previously submitted section IDs.
- Missing or Incorrect Revised Date Entry: The Revised Date in the SPL must accurately match the date provided in the PIL; however, this poses a challenge when the required date is in the past, as the tool automatically captures the current date and time during editing.
- Timeliness: Submissions are often required within 24 hours, leaving limited time for SPL XML preparation, validation, and formatting especially when dealing with complex technical content.
Solutions:
- Complex SPL Standards: Techsol team conducted thorough review of FDA SPL guidelines to ensure accurate formatting, terminology, and metadata compliance. Using tools like the Pragmatic Validator, the team quickly identified and resolved formatting and validation issues.
- Addition of Images: Our team optimizes image formatting and placement to meet SPL structural requirements, preventing reference value errors and ensuring smooth validation.
- Formatting Tables: Techsol reformats tables using SPL guides to remove disallowed attributes, ensuring error-free submission.
- Section ID Discrepancy: We implement a robust cross-referencing system and maintain and ensure IDs are unique and consistent across all submission files.
- Missing or Incorrect Revised Date Entry: The team manually adjusts and validates the revised date in alignment with PIL, overriding auto-generated date to ensure regulatory consistency.
- Timeliness: With a dedicated SPL team and pre-configured workflows, Techsol delivers compliant SPLs within 24 hours, even under urgent timelines.
Project Achievements:
The Techsol team has consistently delivered over 100+ Structured Product Labeling (SPL) submissions to date, ensuring all were error-free, submitted within agreed timelines, and fully aligned with regulatory labeling standards and client-specific requirements.
End-to-End SPL Lifecycle Management:
- Techsol successfully managed the full Structured Product Labeling (SPL) activities, including creation for new products, safety-related SPL updates, and regulatory delisting of discontinued products.
- Created high-quality, XML-based SPLs for newly approved drugs using accurate metadata, structured content sections, and FDA-compliant terminology.
- Updated key sections including Warnings and Precautions, Adverse Reactions, Drug Interactions, and Patient Counselling, ensuring alignment with current FDA safety requirements. Integrated complex tables, revised labels, and embedded images without validation errors.
- Updated product marketing status leading to successful delisting of obsolete products from FDA systems. Maintained data integrity and ensured seamless delisting from DailyMed with no XML Errors.
Error-Free Submissions:
- Addressed complex XML formatting issues including attribute errors, section ID mismatches, and revised date discrepancies.
- Used FDA validation tools and manual checks to eliminate all structural and content-related validation issues.
- Achieved a 100% success rate in FDA SPL validation with zero rejections or resubmissions.
Streamlined Processes:
- Developed a standardized internal SPL QC checklist and validation process that ensured consistency and reduced turnaround time.
- Maintained continuous communication with the client’s regulatory team for data collection, content approval, and expedited review cycles.
Timely Submission:
- Established SPL authoring team capable of completing high-quality SPLs within 01 business day during priority submissions.
- Demonstrated flexibility and reliability in delivering under stringent regulatory deadlines without compromising quality and compliance.
Client Appreciation and Feedback: We would like to express our appreciation to the Techsol team for the timely delivery of high-quality regulatory SPL Your consistent adherence to timelines and exceptional attention to detail have significantly contributed to the efficiency and success of our submission process.
The Outcome:
- XML file creation: SPL XML files were created, updated and delisted as per client’s requirement.
- Regulatory Compliance: All SPL submissions complied fully with FDA and HL7 standards, with no validation errors or format-related rejections.
- Zero Errors: Submitted SPLs were thoroughly reviewed and passed all technical validations, ensuring FDA acceptance.
- On-Time Delivery: Completed SPL creation, update, and delisting within the client’s defined timelines, supporting their regulatory strategy and market commitments.
- Published on DailyMed: The final SPL XML file is submitted to USFDA and published on DailyMed.