Streamline and Automate SPL/SPM submissions with
Structured Product Labeling (SPL) & Structure Product Monograph (SPM) are the mandatory document mark-up standards for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format.
The US FDA has mandated SPL requirements for over 50 types of documents, and HC has mandated SPM requirements for over 6 types of documents. They are also mandated for various types of products including human prescription/Standard template at HC drugs (labeling of pharmaceutical products, biological and generic drugs), over-the-counter (OTC) products, veterinary medicine, homeopathic products, bulk ingredients, etc. Some of the common document types SPL/SPM format that are supported by the US FDA and Health Canada are listed below.
Structure Product Monograph (SPM) is the mandatory document mark-up standard for Regulatory submission of label content. As SPL format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA) while SPM is for Health Canada.
The transition period provided by Health Canada to make the shift easy for industry systems to completely plan for Fall 2020. Health Canada extended timelines and decided to make XML format a mandatory requirement by Winter 2021.
As per the Health Canada directives, adoption of technology, administering, handling, labeling and details of any label changes made, including changing the content of the formatted label and changing the carton labeling or container labeling must be electronically submitted using Structure Product Monograph (SPM) format.
Adapting a new change is always a task in an industry but we are proud to assure you that we have Freyr SPL/SPM, an integrated tool imbibed with all the current updates in industry, that provides a complete solution for Health Canada SPM requirements. Freyr is supporting to perform pilot activities for major clients in the pharma industry.
Freyr SPL/SPM software is enhanced with extensive features like text comparison, data migration, automation, validation and integration with EDMS. We have introduced both on cloud and on-premises models to help client in reduction of time taken for implementation by providing cost-effective solutions for SPL/SPM submissions.
Freyr SPL/SPM Expertise
- Administration of users, roles, SPL/SPM data elements, company & products information
- Email notifications to stakeholders with annual notifications and workflow updates
- SPL/SPM and supporting documents repository and SPL/SPM versions management
- Bulk SPLs/SPMs data migration at the time of client site hosting
- Open web APIs that can be integrated with leading DMS systems
- Robust, user friendly web interface
- Submission Life Cycle Management
- Text compare
- Up versioning the existing SPLs and SPMs
- Health Agency validation rules based on the updated guidelines
- Reduced manual efforts and time taken to work with XMLs with the help of automation
- Administration of users, roles, FDA SPL data elements and Health Canada SPM data elements, company and products information
- Bulk SPL/SPM data migration
- Open architecture integrated with leading document management system (DMS)
- Compliant with HL7 SPL/SPM specifications
- Compliant with 21 CFR Part 11 (e-signature, Audit trails, etc.)