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How can you identify GMP risks in pharmaceutical manufacturing?

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Good Manufacturing Practice (GMP) is a set of standards and guidelines that ensure the quality, safety, and efficacy of pharmaceutical products. However, following GMP is not enough to prevent or eliminate all possible risks that may affect the manufacturing process, the product, or the patient. Therefore, it is essential to identify, assess, and manage GMP risks in a systematic and proactive way. In this article, you will learn how to use some practical tools and methods to identify GMP risks in pharmaceutical manufacturing.

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1 What are GMP risks?

GMP risks are the potential hazards or failures that may compromise the quality, safety, or efficacy of a pharmaceutical product or the compliance with GMP regulations. GMP risks can arise from various sources, such as raw materials, equipment, facilities, personnel, procedures, documentation, validation, testing, storage, distribution, or post-marketing surveillance. GMP risks can have different impacts, such as product defects, recalls, deviations, non-conformities, complaints, adverse events, or regulatory actions.

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Paul Spencer, MBA, BSChemEng, PE, PMP

Problem resolution specialist with multiple contacts as clients and resources. Specialist in leading teams to success
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There are often process steps that have "Tribal Knowledge " from legacy changes to batch records. Clear, defined documents are somewhat followed by individuals that have worked on steps for many years. Or a development person for a process may have not thought of a scaleup challenge. These impact the GMP nature of a product.

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Abel Salazar

Manager
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Back in 2000 a lab tech at our lab used an expired reagent and caused a hold on our plasma units in storage. There were many units involved. I was the Project Manager tasked with bringing all results to a main facility and identifying and clearing results from these units. I worked on this project for four months until we cleared all units on hold. I had four teams made up of an Operation Manager and a Quality Specialist releasing the units. There was a Regional Quality Manager and me, who had to sign off on all paperwork. I was a Regional Operations Manager with Seramed/ Serologicals at the time. This is what happens when people are careless with testing.

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Bill M.

Manager, Engineering Services
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Another example would be complacency towards maintenance procedures. Maintenance technicians must be vigilant to read maintenance task instructions each time work is performed in case a change was made since the last work was done. We all have to read so many SOP updates that sometimes we can forget that a very familiar procedure has changed.

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2 Why is GMP risk identification important?

GMP risk identification is the first and most important step in GMP risk management and assessment. It involves collecting and analyzing information about the manufacturing process and the product characteristics, as well as identifying the potential sources and causes of GMP risks. By identifying GMP risks, you can prioritize them according to their likelihood and severity, and plan appropriate measures to prevent, reduce, or control them. GMP risk identification also helps you to comply with the regulatory expectations and requirements for GMP risk management and assessment.

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Abel Salazar

Manager
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When identifying GMP we need to be careful that we do not just change a procedure to satisfy an inspecting agency. We must look at all the things that might affect both quality and operations in the company.

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3 How to identify GMP risks?

Identifying GMP risks in pharmaceutical manufacturing can be done through several tools and methods, such as process mapping, failure mode and effects analysis (FMEA), hazard analysis and critical control points (HACCP), and risk ranking and filtering. Process mapping provides a graphical representation of the manufacturing process, allowing you to visualize the process flow and identify potential sources of GMP risks. FMEA is a systematic technique that identifies the possible failure modes of each process step, their effects, and their causes. HACCP is a preventive approach that identifies hazards that may affect product quality, safety, or efficacy, as well as corresponding control points. Lastly, risk ranking and filtering uses predefined criteria to rank and filter GMP risks according to importance and relevance. These tools and methods can help you to focus on the most significant GMP risks and allocate resources accordingly.

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Abel Salazar

Manager
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When identifying a GMP risk one must first identify what part of GMP is being compromised and then look at the process to see where the process or procedure failed.

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4 How to document GMP risk identification?

When conducting GMP risk identification, it must be documented in a clear, concise, and consistent way, following the principles of good documentation practice (GDP). The documentation should include the scope and objectives of the GMP risk identification, the roles and responsibilities of the team, the sources and references of the information used, the tools and methods employed, the results and outcomes of the GMP risk identification, any assumptions and limitations, as well as any recommendations or actions derived from it.

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Abel Salazar

Manager
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In documenting risk identification, one must use our logic, we must ask ourselves these questions; What? When? Where? and Who? document this a simply as possible, because we do not know our audience at this time.

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5 How to improve GMP risk identification?

GMP risk identification is a continuous and dynamic process that should be updated and reviewed regularly. To improve this process, you should involve a multidisciplinary team with relevant knowledge, experience, and skills. A combination of qualitative and quantitative tools and methods should be used to consider all possible scenarios and perspectives. Seeking feedback and input from internal and external stakeholders is also important, as well as incorporating the lessons learned from previous incidents and best practices. Finally, it is essential to monitor and evaluate the effectiveness of the GMP risk identification.

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Abel Salazar

Manager
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My experience in improving GMP risk identification and best practice, would be to send the process or risk identified to a team in the field. They can tell you if it is still a viable process.

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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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How can you identify GMP risks in pharmaceutical manufacturing?

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1 What are GMP risks?

2 Why is GMP risk identification important?

3 How to identify GMP risks?

4 How to document GMP risk identification?

5 How to improve GMP risk identification?

6 Here’s what else to consider

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