Learn how to lead and influence GMP quality systems in your organization by following these six steps: assess, define, engage, monitor, review, and communicate.

Implementing advanced quality metrics to monitor & improve GMP compliance is crucial for identifying areas of improvement. I developed a set of key performance indicators (KPIs) that tracked critical aspects of our GMP compliance, including deviation rates, audit findings & corrective action closure times. By regularly reviewing these metrics with the team, we identified areas for improvement, leading to 20% reduction in deviations over 6 months Strengthening supplier quality management ensures that all materials & components meet GMP standards, reducing risks in manufacturing process. I led a project to enhance our supplier qualification process, which included more rigorous initial evaluations, regular audits, & performance monitoring.

Last updated on Jul 12, 2024

How do you lead and influence GMP quality systems?

Good Manufacturing Practice (GMP) is a set of standards and guidelines that ensure the quality, safety, and consistency of products in the pharmaceutical, biotechnology, and medical device industries. GMP quality systems are the backbone of any GMP-compliant organization, as they define the policies, procedures, and controls for all aspects of the product lifecycle. As a leader in your organization, you have a critical role in influencing and shaping the GMP quality systems to meet the regulatory requirements and customer expectations. In this article, you will learn how to lead and influence GMP quality systems by following these six steps:

1 Assess the current state

The first step to lead and influence GMP quality systems is to assess the current state of your organization's quality performance, culture, and compliance. You can use various tools and methods to collect and analyze data, such as audits, inspections, risk assessments, quality metrics, feedback surveys, and root cause analysis. The goal is to identify the strengths and weaknesses of your quality systems, as well as the gaps and opportunities for improvement.

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Sameer Kalghatgi, PhD

Director of Manufacturing @ Fujifilm Diosynth Biotechnologies | Advanced Therapies
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This is the first place where most well meaning leaders trip up. Do not go into it with the intention of playing the blame game, finding the low hanging fruit - people, and throw them under the bus for the sake of a quick win. No one wants to purposely follow or adhere to non-compliant practices. It is really important to perform an emotion free, blame free gap analysis and involve the people who would be responsible to adhere to compliant practices. Celebrate what is going well, identify gap, try to find why the gaps exist, and brainstorm to come up with some ideas to bridge the gap - better software, additional or comprehensive training, reduce burden on overworked employees, metrics based approach.

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Ifeanyi AMAH (MEM in-view), MNSE, MIAENG,

Mechanical Specialist/ Engineer |Process Operator at CCHBC with 4 year experience in FMCG | * ONO| Project Engineer
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Ascertain the norm or what the current trend Assess critically for loopholes, drawbacks, inconsistencies, gaps Come up with and recommend a fool proof solution Pitch this solution Drive this alternative way(solution) Sustain

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2 Define the vision and goals

The next step is to define the vision and goals for your GMP quality systems, based on the assessment results and the strategic objectives of your organization. You should communicate a clear and compelling vision of what you want to achieve and why it matters, as well as set specific, measurable, achievable, realistic, and time-bound (SMART) goals for each quality system element. You should also align your vision and goals with the regulatory expectations and industry best practices.

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3 Engage and empower your team

The third step is to engage and empower your team to implement and maintain the GMP quality systems. You should involve your team members in the planning and decision-making process, as well as provide them with the necessary training, resources, and support. You should also foster a culture of quality, where your team members understand their roles and responsibilities, follow the quality standards and procedures, and report and resolve any quality issues. You should also recognize and reward your team members for their quality achievements and contributions.

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Sameer Kalghatgi, PhD

Director of Manufacturing @ Fujifilm Diosynth Biotechnologies | Advanced Therapies
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It’s only common sense to include and engage the front line staff when it comes to planning and decision making for transforming the quality and GMP culture from the grassroots. Far too often leaders lay the road for quality, but don’t really know the path that the front line workers walk on when it comes to establishing and enforcing GMP culture. A punitive action for a mistake is not going to fix the issue or improve the culture, instead use these incidents as a learning and use it to implement better quality processes to reduce quality incidents and improve quality to attain higher right-first-time score.

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4 Monitor and measure the progress

The fourth step is to monitor and measure the progress of your GMP quality systems, using the quality metrics and indicators that you have established. You should track and evaluate the performance of your quality systems against the goals and benchmarks, as well as identify any deviations, trends, or risks. You should also collect and review feedback from your internal and external stakeholders, such as customers, suppliers, regulators, and auditors.

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5 Review and improve the process

The fifth step is to review and improve the process of your GMP quality systems, based on the monitoring and measurement results and feedback. You should conduct regular reviews and audits of your quality systems, as well as implement corrective and preventive actions (CAPA) to address any nonconformities or deficiencies. You should also apply continuous improvement techniques, such as lean, Six Sigma, or Kaizen, to optimize your quality processes and eliminate waste and variation.

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6 Communicate and share the results

The final step is to communicate and share the results of your GMP quality systems, both internally and externally. You should report and document the outcomes and achievements of your quality systems, as well as the challenges and lessons learned. You should also share the best practices and success stories of your quality systems, as well as the feedback and recognition from your stakeholders. You should also celebrate and appreciate your team's efforts and accomplishments in leading and influencing GMP quality systems.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Dr Reji Kurien Thomas

I Empower Sectors as a Global Tech & Business Transformation Leader| Stephen Hawking Award| Harvard Leader | UK House of Lord's Awardee | Fellow Royal Society | CyberSec I 175x LinkedIn Top Voice | CCISO CISM
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Implementing advanced quality metrics to monitor & improve GMP compliance is crucial for identifying areas of improvement. I developed a set of key performance indicators (KPIs) that tracked critical aspects of our GMP compliance, including deviation rates, audit findings & corrective action closure times. By regularly reviewing these metrics with the team, we identified areas for improvement, leading to 20% reduction in deviations over 6 months Strengthening supplier quality management ensures that all materials & components meet GMP standards, reducing risks in manufacturing process. I led a project to enhance our supplier qualification process, which included more rigorous initial evaluations, regular audits, & performance monitoring.

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How do you lead and influence GMP quality systems?

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1 Assess the current state

2 Define the vision and goals

3 Engage and empower your team

4 Monitor and measure the progress

5 Review and improve the process

6 Communicate and share the results

7 Here’s what else to consider

GMP

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