Building a Compliant SOP Framework for a Local Pharma Company
How we established a rock-solid operational foundation for a leading pharmaceutical distributor in Kenya.
The Challenge
A local pharmaceutical company, a leading clinical trials service provider in Kenya, was on the verge of opening a new, state-of-the-art warehousing facility.
To ensure a successful launch and immediate compliance with the Pharmacy and Poisons Board (PPB) regulations, they required a comprehensive Standard Operating Procedure (SOP) framework that covered every aspect of their operations-from goods-in to final dispatch.
Key Requirements: Complete SOP framework, PPB compliance, staff training readiness, and pre-audit preparation-all within a tight timeline.
Our Solution
The Pharma Partner was engaged to lead the development and implementation of this critical SOP framework.
Our approach was hands-on and collaborative, focusing on creating procedures that were not only compliant but also practical for their team to implement.
Our Methodology
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1Gap Analysis: We began with a thorough review of the firm's planned workflows and PPB guidelines to identify all required procedures.
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2SOP Authoring: We authored over 15 distinct SOPs covering key areas such as receiving, quarantine, storage, pest control, cold chain management, picking, packing, and returns.
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3Staff Training: We conducted on-site meetings and training sessions with the firm's warehouse team to ensure a clear understanding and smooth adoption of the new procedures.
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4Pre-Audit Support: We performed a mock audit to pressure-test the new system and prepare the team for the official regulatory inspection.
Key SOPs Delivered
The Result
Thanks to the robust SOP framework, the Local Pharma successfully passed their initial PPB inspection with no major observations.
Their new facility launched on schedule with a fully trained team and a quality system designed for efficiency and compliance.
This foundational work has empowered the firm to scale their operations with confidence, knowing their commitment to quality is built into their daily processes.
We are proud to have played a key role in their journey towards excellence in pharmaceutical distribution.