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How do you measure and improve the quality and efficiency of your GLP and GMP documentation?

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Good laboratory practice (GLP) and good manufacturing practice (GMP) are essential standards for ensuring the quality, safety, and reliability of products and processes in the pharmaceutical, biotechnology, and medical device industries. However, complying with these standards also requires a lot of documentation, which can be time-consuming, complex, and prone to errors. How do you measure and improve the quality and efficiency of your GLP and GMP documentation? Here are some tips and best practices to help you optimize your documentation process.

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William D Fox, MPH CQA

GxP Quality Assurance Professional, Certified Quality Auditor

1 Define your objectives

Before you start writing or revising your GLP and GMP documentation, you need to have a clear idea of what you want to achieve and how you will measure it. Do you want to reduce the number of deviations, corrections, or rejections? Do you want to improve the readability, clarity, or consistency of your documents? Do you want to save time, money, or resources? Define your objectives and set specific, measurable, achievable, realistic, and time-bound (SMART) goals for your documentation process.

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Stewart Neithercut

Business Development Manager at Tepnel Pharma Services
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The person writing or revising documentation must have a complete understanding of the process. Readability, clarity and consistency requires peer review of current, future and past operators where available. Clarity as to purpose and outcomes of documentation needs to be clearly defined in the introduction.

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2 Follow the guidelines

The next step is to follow the guidelines and regulations that apply to your industry and product. Depending on the type and scope of your documentation, you may need to comply with different GLP and GMP principles, such as those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other national or regional authorities. Make sure you understand the requirements and expectations for your documentation and use the appropriate templates, formats, and terminology.

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William D Fox, MPH CQA

GxP Quality Assurance Professional, Certified Quality Auditor
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Simplify the ability to revise SOPs. To often I have audited an process and come to find out that there was great variation in the actual process. Many front line workers are in a better position to know but are yet intimidated by the process of changeing the SOP. So it becomes easier for them to just do it as they see is "the wright way."

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3 Use the right tools

Another way to improve the quality and efficiency of your GLP and GMP documentation is to use the right tools and software to create, manage, and store your documents. For example, you can use a document management system (DMS) to organize, track, and control your documents throughout their lifecycle. You can also use a word processor or an editor that supports features such as spell check, grammar check, formatting, version control, and collaboration. Moreover, you can use a validation tool or a software quality assurance (SQA) tool to verify and test your documents for accuracy, completeness, and compliance.

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Utiéyin Dediare

Pharmacist, Clinical Operations & Design Strategist
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QPULSE ??was helpful in the it could amalgamate _ automate maintenance of the SOPs even from the other clinical and QA - QC specialties that fed into the GMP. The email notification option to the users was a double edged sword- but it needs a good grasp of your systems users and processes. Always remember to declutter the processes and procedures with a process map that will give the process times, people and fundamentals before embarking on such a project… pilot it first then roll out for general consumption.

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4 Review and update regularly

Even if you have created your GLP and GMP documentation according to the guidelines and using the right tools, you still need to review and update them regularly to ensure they reflect the current state of your products and processes. You should conduct periodic reviews and audits of your documentation to identify any gaps, inconsistencies, or errors that need to be corrected or improved. You should also update your documentation whenever there are any changes or modifications in your products, processes, methods, equipment, or regulations that affect your documentation.

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5 Train and communicate

Finally, you can improve the quality and efficiency of your GLP and GMP documentation by training and communicating with your staff and stakeholders. You should provide adequate training and guidance to your staff on how to write, review, approve, and use your documentation according to the standards and procedures. You should also communicate with your stakeholders, such as customers, suppliers, regulators, or auditors, on how to access, interpret, and verify your documentation. By training and communicating, you can ensure that everyone involved in your documentation process is on the same page and understands their roles and responsibilities.

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How do you measure and improve the quality and efficiency of your GLP and GMP documentation?

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1 Define your objectives

2 Follow the guidelines

3 Use the right tools

4 Review and update regularly

5 Train and communicate

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