Mastering Modified Release: A Guide to Optimizing Oral Solid Dosage Processes in Pharmaceutical Manufacturing

Introduction

As a Process Engineer within the Manufacturing Science and Technology (MS&T) division, Process Management stands as a cornerstone of our daily endeavors. Integral to our role is the strategic steering and refinement of manufacturing processes for oral solid dosage forms, particularly those with modified release attributes. This involves a continuous and iterative cycle through which we strive to drive innovation, enhance efficiency, and maintain the utmost quality.

In the context of our daily work, Process Management is the meticulous orchestration of various activities aimed at ensuring the commercial manufacturing processes under our watch are not only robust but also cost-effective and environmentally conscious. Using both conventional and novel technological approaches, we are champions of process excellence—responsibly shepherding products through their lifecycle, from conception to patient delivery, with an eye for the most nuanced improvements in performance.

Our commitment to Process Management means that we are persistently on the lookout for opportunities to innovate processes, optimize production methodologies, and troubleshoot any arising issues. By applying sophisticated techniques, such as process simulation, we are able to anticipate challenges in scaling up or transferring technology, thus preempting inefficiencies or potential quality concerns. This proactive stance ensures that we can refine our processes, sustainably minimize waste, and contribute to the overall success of our operations.

At the heart of our Process Management endeavours is the dedication to develop manufacturing processes that not only meet but exceed the stringent industry standards, thereby ensuring that patients receive high-quality, reliable products that improve health outcomes. Through relentless pursuit of process optimization, we as Process Engineers embody the driving force behind innovative solutions that yield tangible benefits across the entire spectrum of pharmaceutical manufacturing.

KanBo: When, Why and Where to deploy as a Process Management tool

What is KanBo?

KanBo is an adaptable process management tool that facilitates effective organization, visualization, and collaboration for teams handling various workflows and projects. It operates within a hierarchical model of workspaces, folders, spaces, and cards that allows team members to manage tasks, track progress, and improve communication.

Why should Process Engineers use KanBo?

Process Engineers should use KanBo as it provides a centralized platform to manage complex projects, optimize workflows, and enhance productivity. With features like card grouping, Gantt Charts, Forecast Charts, and real-time updates, engineers can streamline process planning, monitor timelines, identify bottlenecks, and forecast completion dates. KanBo's flexibility enables customization to fit specific process engineering needs, such as process design, execution, monitoring, and improvement.

When is KanBo most beneficial?

KanBo is most beneficial during the planning, execution, and monitoring phases of a process. It helps in setting clear milestones, delegating tasks, and tracking progress against deadlines. During periods that require collaborative efforts, KanBo enhances communication, transparency, and accountability among team members. It is also valuable when analyzing and optimizing processes for greater efficiency, as it offers visual tools and analytical insights.

Where can KanBo be utilized by Process Engineers?

Process Engineers can utilize KanBo across a variety of environments, including but not limited to research and development, manufacturing, quality assurance, and continuous improvement initiatives. Its versatility enables use in both office settings and on the production floor, with the ability to access the platform through various devices and integrate with commonly used Microsoft applications.

Should a Process Engineer (MS&T Specialist II) use KanBo as a Process Management tool?

Yes, a Process Engineer should use KanBo as a Process Management tool. It can significantly enhance their ability to manage projects efficiently, align cross-functional teams, and maintain oversight of operational processes. KanBo's capabilities in managing tasks, setting dependencies, resolving bottlenecks, and providing analytics support a Process Engineer's goal of continually improving systems and maintaining high-quality standards in the manufacturing and technology space.

How to work with KanBo as a Process Management tool

Instructions for a Process Engineer (MS&T Specialist II) Using KanBo for Process Management in a Business Context

Setting Up Your KanBo Environment

1. Create a Workspace (Purpose: Centralizing Process Management)

Why: A dedicated workspace for Process Management creates a centralized location where all process-related projects and tasks can be monitored and tracked against the organization’s strategic goals.

- Access the KanBo dashboard.

- Click on the plus icon (+) or "Create New Workspace."

- Name the workspace “Process Management” and provide a related description.

- Choose Workspace type as Private to ensure data security.

- Set roles and permissions for relevant team members.

2. Create Folders and Spaces (Purpose: Categorizing Processes)

Why: Organizing spaces within folders allows for a clearer structure, making it easier to manage individual processes by category (e.g., production, quality assurance, logistics).

- Click on "Add new folder" and name appropriately (e.g., "Quality Processes").

- Inside each folder, create Spaces that represent individual processes (e.g., "Batch Record Review").

- Assign team members to each Space based on their role in the process.

Process Analysis and Design

3. Create Cards for Process Tasks (Purpose: Process Decomposition)

Why: Cards serve as components of a process and their detailed breakdown allows for in-depth analysis and understanding of each step for potential refinement.

- Within a Space, add a Card for every key step in a process.

- Include relevant details, owners, and deadlines for each Card.

Execution and Monitoring

4. Utilize Card Statuses (Purpose: Tracking Progress)

Why: Card statuses help visualize where the task is in its lifecycle, facilitating proactive management and timely interventions to minimize disruptions and maintain workflow momentum.

- Update Card statuses as tasks move from "To Do" to "In Progress," then to "Completed."

- Monitor the Card activity stream for real-time updates.

5. Outline Card Blockers (Purpose: Identifying Constraints)

Why: Highlighting blockers helps in pinpointing challenges or bottlenecks that can impede the process flow, allowing for targeted problem-solving.

- Add a Card Blocker to any task facing an obstacle.

- Categorize the blocker to clarify whether it’s a local, global, or on-demand issue.

Continuous Improvement

6. Analyze the Space with Gantt and Forecast Charts (Purpose: Process Improvement)

Why: Using KanBo's visual tools provides insights into process timelines and workloads, identifying improvement opportunities.

- Regularly review the Gantt Chart view for an overview of the processes along a timeline.

- Utilize the Forecast Chart to predict process completion and adjust workload.

7. Refine Processes with Card Relations and Statistics (Purpose: Optimization)

Why: Understanding the interdependencies between tasks and reviewing performance statistics supports informed decision-making to enhance overall process efficiency.

- Establish card relationships to define dependencies within the process.

- Review card statistics to identify trends in performance and areas for optimization.

Documentation and Standardization

8. Employ Document Templates and Card Templates (Purpose: Consistency and Knowledge Retention)

Why: Utilizing templates ensures standardization and best practices across the company, making it easier to maintain consistent documentation and train new employees.

- Create Document Templates for standard operating procedures (SOPs).

- Use Card Templates for repetitive tasks to maintain consistency.

Collaboration and Communication

9. Facilitate Team Collaboration (Purpose: Team Efficiency)

Why: Seamless teamwork is essential in ensuring smooth, uninterrupted process management within a collaborative space.

- Assign team members to relevant Cards and Spaces.

- Communicate actively using the comments section and mentions.

- Coordinate problem-solving efforts with team presence indicators.

Reflection and Recap

10. Review Workspaces Regularly (Purpose: Strategic Alignment)

Why: Regular workspace reviews ensure that the process management efforts remain aligned with the company's strategic objectives, identifying areas of success and those needing improvement.

- Schedule a monthly review of the entire Workspace.

- Assess if the processes within each Space are achieving desired efficiencies and match strategic goals.

- Adjust processes and tasks as needed, based on insights gained.

Through these steps, you will leverage KanBo to optimize your process management, aligning day-to-day operations with broader business goals, and striving for continuous improvement to sustain organizational growth and operational excellence.

Glossary and terms

Process Management: The practice of analyzing, designing, executing, monitoring, and improving business processes to enhance efficiency, effectiveness, and alignment with organizational goals.

Process Engineer: A professional who focuses on designing and implementing process systems for scaling production, improving quality, and optimizing workflows.

MS&T Specialist II: A role in the pharmaceutical industry that stands for Manufacturing, Science, and Technology Specialist, Level II, often involved in process development and improvement.

Workspace: An organizational level within a process management tool that groups related spaces (projects or teams) together for better navigation and collaboration.

Space: A collection of cards (tasks or items) in a digital environment that visually represents a workflow and is typically project-specific or represents an area of focus.

Card: The smallest unit of work within a process management platform, representing an actionable item or task with relevant details like notes, files, comments, and due dates.

Card Status: An indicator that shows the current stage or condition of a card, such as "To Do" or "Completed," for organizing workflow and calculating progress.

Card Activity Stream: A real-time log of all activities and updates associated with a card, providing a chronological history of actions and fostering transparency.

Card Blocker: An issue or obstacle hindering the progress of a task represented as a card.

Card Grouping: A way to categorize cards based on criteria such as status, user, or due date to efficiently organize and manage tasks.

Card Issue: A problem associated with a card that impedes its effective management, often highlighted with specific colors to indicate urgency.

Card Relation: A dependency link between cards where one card's progress may depend on the completion of another, categorized as parent-child or sequential relationships.

Card Statistics: Analytical insights offered by the process management platform showing visual representations of a card’s lifecycle, including charts and summaries.

Dates in Cards: Specific schedules associated with cards such as start date, due date, and reminders that represent important milestones or durations.

Completion Date: The specific date when the status of a card is changed to "Completed," signifying the task's conclusion.

Default Parent Card: In cases where a card has multiple parent cards, one is designated as the main card for progress tracking and hierarchical organization.

Forecast Chart View: A visual representation of project progress that provides data-driven forecasts based on the velocity of work completion, aiding in predictive analysis and planning.

Gantt Chart View: A space view displaying time-dependent cards along a timeline, allowing for chronological tracking and advanced planning of tasks and milestones.

Grouping: The act of organizing related cards within a space based on specified categories to enhance management and order.

List: A custom field type used to categorize cards within a space, with each card being assignable to only one list for clarity and organization.