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What are the best ways to improve GMP quality while keeping costs low?

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If you work in the pharmaceutical, biotechnology, or medical device industry, you know how important it is to follow good manufacturing practices (GMP) to ensure the quality, safety, and efficacy of your products. However, you also know how challenging and costly it can be to meet the regulatory standards and customer expectations. How can you improve your GMP quality while keeping your costs low? Here are some best practices that can help you achieve both goals.

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Keval Pednekar

Quality Assurance Auditor

1 Conduct a gap analysis

A gap analysis is a systematic process of identifying and evaluating the differences between your current GMP performance and the desired or required level. It can help you pinpoint the areas where you need to improve, prioritize the actions you need to take, and allocate the resources you need to implement them. A gap analysis can also help you avoid unnecessary or redundant activities that do not add value to your quality system or your products.

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Keval Pednekar

Quality Assurance Auditor
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In my opinion to improve GMP quality while minimizing costs, focus on streamlining processes, optimizing resource utilization, enhancing supplier relationships, implementing efficient quality control measures, and utilizing lean manufacturing principles. Additionally, prioritize preventive maintenance, invest in automation where feasible, optimize inventory management, and foster a culture of quality consciousness among employees.

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Muhammad Muddassir Siddique

Manager Microbiology at Evolution Pharmaceuticals (Pvt) Ltd.
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1- Fix the batch size (Large batch size) it can reduce the a- material transport cost b- raw material testing cost c- batch whole process testing(inprocess, finished) cost. d- power, labour, paper usage etc.

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2 Implement a risk-based approach

A risk-based approach is a method of applying the appropriate level of control and oversight to your GMP processes and activities based on the potential impact they have on the quality, safety, and efficacy of your products. It can help you focus your efforts and resources on the most critical aspects of your quality system, such as design, validation, testing, and monitoring. A risk-based approach can also help you reduce the likelihood and severity of errors, deviations, and non-conformities that can compromise your GMP quality.

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3 Adopt a continuous improvement culture

A continuous improvement culture is a mindset and a practice of constantly seeking ways to enhance your GMP quality and efficiency. It can help you foster a learning environment where you and your team members are encouraged to identify and solve problems, share best practices, and implement changes that can improve your processes and products. A continuous improvement culture can also help you adapt to the changing regulatory requirements and customer expectations and stay ahead of the competition.

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4 Use digital tools and technologies

Digital tools and technologies are devices and systems that can help you automate, streamline, and optimize your GMP processes and activities. They can help you collect, store, analyze, and share data and information that can support your quality decision-making and actions. They can also help you enhance your communication, collaboration, and coordination with your internal and external stakeholders. Some examples of digital tools and technologies that can improve your GMP quality include software, sensors, scanners, cameras, and cloud platforms.

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5 Train and empower your staff

Your staff are your most valuable asset when it comes to improving your GMP quality. They are the ones who perform, manage, and oversee your GMP processes and activities. Therefore, it is essential that you train and empower them to perform their roles and responsibilities effectively and efficiently. You can do this by providing them with the necessary knowledge, skills, tools, and feedback that can help them achieve the quality objectives and standards. You can also do this by involving them in the planning, implementation, and evaluation of the quality improvement initiatives and rewarding them for their contributions and achievements.

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David Jones

Large Scale Manufacturing at Wyeth, Pfizer and Biogen Pharmaceuticals
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Continuous training is important. Annual refreshing via e-learnings will keep your staff on track. Make sure the training is inter-active. Knowledge checks will ensure staff understood the training.

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6 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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What are the best ways to improve GMP quality while keeping costs low?

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3

4

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1 Conduct a gap analysis

2 Implement a risk-based approach

3 Adopt a continuous improvement culture

4 Use digital tools and technologies

5 Train and empower your staff

6 Here’s what else to consider

Quality Management

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What are the best ways to improve GMP quality while keeping costs low?

1

2

3

4

5

6

1 Conduct a gap analysis

2 Implement a risk-based approach

3 Adopt a continuous improvement culture

4 Use digital tools and technologies

5 Train and empower your staff

6 Here’s what else to consider

Quality Management

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