SOP Consolidation across Multiple Global Sites Promotes Move towards Lean Operations

SOp consolidation

Brevitas consultants provided technical and compliance expertise to a leading Canadian pharmaceutical company for the revision and creation of global GMP, GLP and GCP Standard Operating Procedures (SOPs). Within 5 months, the number of global R&D SOPs was reduced from 100 to 50, to help achieve lean operations.

Industry

Pharmaceuticals

Area of Expertise

Regulatory Compliance

Duration

7 months

Services Provided

  • Project Management
  • Technical Documentation
  • Organizational Change Management

Impact

SOP consolidation helped the R&D department of a leading Canadian pharmaceutical company achieve lean operations by reducing the number of redundant SOPs and creating global policies for standard use.

Business Challenge

Our international client was faced with a tight timeline to complete a lean documentation initiative across multiple global sites, including Canada, the United States, India, and Europe. The goal was to reduce the number of redundant R&D SOPs and create new global policies & SOPs, incorporating current regulatory expectations (FDA, EU, Canada). The completion of the project was crucial to achieve lean operations across all global sites.

Our Approach

Brevitas consultants expedited the reduction and revision of Standard Operating Procedures in 5 short months. They consolidated duplicate procedures and reduced the number of redundant documents which increased the efficiency of R&D documentation. The consultants then developed process maps to identify gaps and make improvements to procedures and policies across multiple global sites.

Results Achieved

  • Created new global GMP, GLP, and GCP policies and SOPs to improve compliance across all sites
  • Harmonized R&D SOPs reducing the document quantity from 100 to 50 across global sites within a 5-month timespan
  • Developed 80 global GMP, GLP, & GCP SOPs and policies to streamline the processes across all global sites

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