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P101: Transforming Traditional SOPs and Creating Job Aids to Improve Consistency and Enhance Regulatory Compliance

Poster Presenter

      Kurt Douglass

      • Director, GPV Compliance & Business Management (CBM)
      • Otsuka Pharmaceutical Development & Commercialization, Inc.
        United States


To harmonize and enhance the efficiency of standard operating procedures (SOPs) of pharmacovigilance (PV) controlled documents by transforming all traditional and local SOPs into centralized global SOPs with related Working Practices (WP). Job Aids (JA) were created to support local practice.


The harmonization project was divided into four phases - gap analysis, impact analysis, create/retire, and implementation. More than 75 local SOPs (LSOPs) were compared with global SOPs (GSOPs) by analyzing the current processes at a local and regional level as part of the integration efforts.


Global Transformation Workshop was conducted to perform the gap analysis. The attendees included members from Global Pharmacovigilance, Medical Affairs, Clinical, and Regulatory Affairs, and PV Stakeholders. The European Union Quality Person for Pharmacovigilance (EU QPPV) served as moderator. Decentralized oversight of SOPs led to inconsistencies and redundancies, which were identified during the gap analysis. The second phase involved examining each procedural section to eliminate redundant steps and harmonize global and local practices taking care to address local or regional regulatory-driven requirements. The third phase involved condensing these practices into centralized global SOPs by document scope, a laborious task, as it involved working with the respective key stakeholders, drafting, and redrafting each procedural section, among others, all while maintaining strict timelines. The final stage involved the upload of the GSOP onto the document repository. Regarding LSOPs, about 11% were reviewed and retained, and where the content of the LSOP could not be incorporated into the GSOP, a controlled JA was developed for approximately 27% of affiliates based on regulatory requirements. The culmination of the Global Harmonization initiative resulted in the effective decommissioning of about 88% of LSOPs, resulting in a 44% reduction in procedural documents.


Harmonizing the traditional SOPs with GSOPs was challenging, as it required a cross-functional and comprehensive strategy. Among the new design’s highlights were the following: 1. Conducting a gap analysis to assess SOP content at a global, regional, and local level 2. Reviewing each procedure section and identifying relevant procedures against shared content 3. Grouping the multiple SOPs for each affiliate into global SOPs 4. Defining the roles and responsibilities of global leads  A consolidated project plan improved the oversight of SOP development and streamlined the communication and alliances between Pharmacovigilance, Medical Affairs, Clinical, Regulatory, and regional teams, among others.  The transformation initiative resulted in developing a coalition among the customer’s regional stakeholders to ensure the harmonization of procedural documents. The harmonization improved the consistency of the procedural documents, enhanced their quality, and reduced the probable risks and non-compliances during future regulatory audits and inspections. Improvements in SOP effectiveness are being monitored. This procedural redesign reinforces the significance of understanding local regulatory environments, involving local affiliate teams in decision-making, and fostering collaboration across multiple functional areas within a global organization. Along with a reduction in the number of SOPs and impact on audit/inspections, the future goal is to continue the global transformation of remaining LSOPs based on the regulatory environment.