Pharmaceuticals Workflows & Process Definitions

What is a Pharmaceutical Process Flow Chart

Pharmaceutical process flow charts, also called workflows, process maps, or value stream maps, are defined as diagrams of pharmaceutical business processes, created graphically in software, drawn by hand, or even laid out with a series of post-it notes, that are used to document procedures and steps of a finite scope of work. Pharmaceutical workflows visually depict granular activities involved in developing a new product, from the initial R&D work to the final packaging and shipping process.

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Identifying Steps in Pharmaceutical Manufacturing Process Flow Charts

The goal of mapping processes in pharmaceuticals manufacturing is to document work steps for a business problem that management is trying to solve. But, identifying the main steps in the beginning, and keeping those steps confined to a reasonable scope, can be tricky. Most pharmaceuticals manufacturing processes have multiple sub-processes that spin off from main work flows, so not all should be mapped at once. Start with the understanding that at the end of your flow chart project, the process should have around 100 steps on it to be thorough enough to use for problem solving or documentation for automation. 4 major steps in the pharmaceuticals manufacturing process that must be captured when creating a work flow include:

1. Staging and weighing of raw materials

2. Compounding, blending, and drying of combined and mixed materials

3. Compounding, blending, and drying of combined and mixed materials

4. Package and prepare final product for shipment and distribution

The Role and Benefits of Pharmaceutical Process Flow Charts

Developing and maintaining process maps for pharmaceutical processes gives several broad benefits. In an industry as regulated as pharma, flow chart and workflow analysis contribute to wider data and process visibility among stakeholders, potentially saving hundreds of hours of work time reducing compliance risk activity – all while providing ideas for better internal controls and efficiency. Benefits of flow charting in pharma include:

• Improved Regulatory Procedures: Requests from regulatory bodies can be tied up due to executive staff working on other projects, but deadlines for replies are almost immediate. Operational readiness is paramount in many cases. These requests can be moved along by less senior members on staff but procedures must be clear on how to proceed and be identified during process mapping.

• Reduced Operational Cost: Back office pharmaceuticals processes can be plagued by duplicate or redundant work steps. Creating a pharmaceutical’s back office workflow, or flow chart, allows companies to identify areas where operations can be simplified or centralized, getting rid of those duplicate processes and saving big dollars on overhead

• Speed to Market Improvement: Getting new products to market can be slowed down by slow approval rates and the speed of product development. Process analysis can be used to develop standardized workflows to get new products created and out to market faster.

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