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Last updated on 2024年8月15日

How do you learn from the best practices in GMP validation and verification?

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GMP validation and verification are essential activities to ensure the quality, safety, and efficacy of pharmaceutical products. They involve testing and documenting the performance of equipment, systems, processes, and methods against predefined specifications and standards. However, validation and verification are not static or one-time events. They require continuous learning and improvement based on the best practices in the industry. In this article, you will discover how to learn from the best practices in GMP validation and verification and apply them to your own projects.

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Juan Valdez, CLSSBB

Senior Executive in Manufacturing & Product Development | Lean Six Sigma Black Belt | Innovator Driving Operational…
Ts. Muhammad Syazwanul Badri Ruslan

CQV Manager | CSV, Process Validation, Automation, Paperless Validation, Project Management, Utilities, HVAC | Master…

1 Define your objectives and scope

The first step to learn from the best practices in GMP validation and verification is to define your objectives and scope clearly. What are you trying to validate or verify? Why is it important? How will you measure the results? What are the acceptance criteria? What are the risks and challenges? By answering these questions, you will have a clear vision of what you want to achieve and how to plan your activities. You will also be able to benchmark your objectives and scope against the best practices in the industry and identify any gaps or opportunities for improvement.

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Juan Valdez, CLSSBB

Senior Executive in Manufacturing & Product Development | Lean Six Sigma Black Belt | Innovator Driving Operational Excellence | Industry 4.0 Leader | Strategic Business Development Expert
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1. Define Objectives and Scope SMART: Establish Specific, Measurable, Achievable, Relevant, and Time-bound goals to ensure clarity and effectiveness in your validation efforts. 2. Use QFD: Apply Quality Function Deployment to translate customer needs and regulatory requirements into precise technical specifications. 3. VSM: Utilize Value Stream Mapping to analyze and optimize processes, identifying areas for improvement and eliminating waste. 4. Benchmarking: Compare your practices with industry leaders to identify gaps and adopt effective strategies, ensuring continuous improvement and adherence to standards.

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Ts. Muhammad Syazwanul Badri Ruslan

CQV Manager | CSV, Process Validation, Automation, Paperless Validation, Project Management, Utilities, HVAC | Master In AI
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I'm 100% agree with the statement. Objective and Scope plays big roles in planning validation or verification activities. There are several factor need to be taken into account to properly define objective an scope such as Product Impact to Quality & Safety, does it impacting other validated system/process, does the changes directly/indirectly impact the product and other. These will be key factor to derive the validation strategy especially when we talked about risk-based approach.

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2 Follow a structured approach

The second step to learn from the best practices in GMP validation and verification is to follow a structured approach that covers all the necessary stages and documentation. Depending on the type and complexity of your validation or verification project, you may need to follow different guidelines or standards, such as ICH Q9, ISO 13485, or ASTM E2500. However, a common framework that applies to most validation and verification projects consists of four phases: planning, design, execution, and review. Each phase should have a clear purpose, deliverables, roles, and responsibilities. You should also follow the principles of change control, traceability, and data integrity throughout the process.

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Ts. Muhammad Syazwanul Badri Ruslan

CQV Manager | CSV, Process Validation, Automation, Paperless Validation, Project Management, Utilities, HVAC | Master In AI
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Structured approach shall be followed when derived a validation/verification plan. This is to ensure all required aspect are covered and following the proper guideline written. If the team would like to defer from the structured approach, proper justification shall be presented with supporting data (where applicable).

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3 Learn from the experts and peers

The third step to learn from the best practices in GMP validation and verification is to learn from the experts and peers who have experience and knowledge in the field. You can find many sources of information and guidance, such as books, articles, webinars, podcasts, courses, or workshops. You can also join professional networks, forums, or communities where you can ask questions, share insights, or seek feedback. By learning from the experts and peers, you will gain valuable tips, tricks, and best practices that you can apply to your own projects. You will also be able to stay updated on the latest trends, innovations, and regulations in the industry.

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Ts. Muhammad Syazwanul Badri Ruslan

CQV Manager | CSV, Process Validation, Automation, Paperless Validation, Project Management, Utilities, HVAC | Master In AI
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Totally agree. Validation is a learning process. for new validation engineer, structured approach are you main goal when planning your activities. With enough experience, simplified approach can be use while maintaining the regulation and quality standard. this can be achieve by presenting a data an scientific justification.

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4 Implement feedback and improvement

The fourth step to learn from the best practices in GMP validation and verification is to implement feedback and improvement based on the results and outcomes of your projects. You should always monitor and evaluate the performance and effectiveness of your validation or verification activities and compare them with your objectives and scope. You should also collect and analyze feedback from your stakeholders, customers, or end-users to identify any issues, gaps, or opportunities for improvement. By implementing feedback and improvement, you will be able to enhance the quality, safety, and efficacy of your products and processes. You will also be able to demonstrate compliance with the regulatory requirements and standards.

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Ts. Muhammad Syazwanul Badri Ruslan

CQV Manager | CSV, Process Validation, Automation, Paperless Validation, Project Management, Utilities, HVAC | Master In AI
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Reviewing process play a big roles in learning GMP validation. this to ensure the next project can be performed much better (better planning, less deviation, less time consume). this reviewing process all good to innovate your validation approach which already gained much needed experience.

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5 Share your knowledge and experience

The fifth step to learn from the best practices in GMP validation and verification is to share your knowledge and experience with others who can benefit from it. You can share your lessons learned, best practices, or case studies through various channels, such as blogs, podcasts, webinars, articles, or presentations. You can also mentor, coach, or train others who are new to the field or want to improve their skills and competencies. By sharing your knowledge and experience, you will be able to contribute to the advancement and innovation of the industry. You will also be able to build your reputation, credibility, and network as a validation or verification professional.

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6 Keep learning and improving

The sixth and final step to learn from the best practices in GMP validation and verification is to keep learning and improving. Validation and verification are dynamic and evolving activities that require constant adaptation and optimization. You should always seek new knowledge, skills, and tools that can help you perform better and faster. You should also always look for new challenges, opportunities, or projects that can test your abilities and expand your horizons. By keeping learning and improving, you will be able to stay ahead of the curve and deliver excellence in GMP validation and verification.

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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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How do you learn from the best practices in GMP validation and verification?

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1 Define your objectives and scope

2 Follow a structured approach

3 Learn from the experts and peers

4 Implement feedback and improvement

5 Share your knowledge and experience

6 Keep learning and improving

7 Here’s what else to consider

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