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How can you address deviations found in a GMP audit?

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A good manufacturing practice (GMP) audit is a systematic and independent examination of your production processes, facilities, documents, and records to verify compliance with the applicable regulations and standards. A GMP audit can reveal deviations, which are any departures from the approved procedures, specifications, or instructions that may affect the quality, safety, or efficacy of your products. How can you address deviations found in a GMP audit? Here are some steps you can follow to resolve them effectively and prevent recurrence.

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Laisa D. Feliciano [CAPA Made Easy]????

I help Quality Leaders of pharma regulated industries build competent empowered teams by simplifying CAPA, Root Cause…

1 Identify the deviations

The first step is to identify the deviations and document them in a clear and accurate manner. You should use a standardized form or system to record the deviations, including the date, time, location, product, batch, auditor, description, category, and impact of each deviation. You should also assign a unique identifier or number to each deviation for easy tracking and referencing.

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Laisa D. Feliciano [CAPA Made Easy]????

I help Quality Leaders of pharma regulated industries build competent empowered teams by simplifying CAPA, Root Cause Analysis and Investigation Reports?? Let’s prevent, quality issues, delays and non-compliances easily.
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Deviations found during audits are commonly identified as observations with an associated risk level. They require to provide a response with an adequate investigation and associated action plan. One important thing is to be clear on the requirement not met so that the action plan is correct and will be effective.

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2 Evaluate the deviations

The next step is to evaluate the deviations and determine their root causes, consequences, and risk levels. You should use a structured and objective method to analyze the deviations, such as the 5 Whys, fishbone diagram, or failure mode and effects analysis (FMEA). You should also consult with the relevant personnel, departments, and stakeholders to gather information and feedback on the deviations. You should then classify the deviations according to their severity, frequency, and potential for harm, and prioritize them for corrective and preventive actions (CAPA).

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3 Implement CAPA

The third step is to implement CAPA to correct the deviations and prevent them from happening again. You should define the objectives, scope, responsibilities, timelines, and resources for each CAPA, and document them in a detailed plan. You should also follow the plan-do-check-act (PDCA) cycle to execute, monitor, verify, and improve the CAPA. You should ensure that the CAPA are effective, sustainable, and aligned with the GMP requirements and best practices.

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4 Report the deviations

The fourth step is to report the deviations and the CAPA to the auditor and the relevant authorities. You should prepare a comprehensive and transparent report that summarizes the deviations, the root causes, the risk assessment, the CAPA, and the results. You should also provide evidence and documentation to support your report, such as records, data, tests, validations, and reviews. You should submit your report within the agreed timeframe and format, and respond to any queries or feedback from the auditor or the authorities.

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5 Review the deviations

The final step is to review the deviations and the CAPA to identify any gaps, weaknesses, or opportunities for improvement. You should conduct a periodic and systematic review of the deviations and the CAPA, and measure their performance, effectiveness, and compliance. You should also use the review findings to update or revise your procedures, specifications, instructions, training, or controls to enhance your GMP compliance and quality management. You should also share your lessons learned and best practices with your team, organization, and industry.

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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 address deviations found in a GMP audit?

1

2

3

4

5

6

1 Identify the deviations

2 Evaluate the deviations

3 Implement CAPA

4 Report the deviations

5 Review the deviations

6 Here’s what else to consider

Quality Management

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How can you address deviations found in a GMP audit?

1

2

3

4

5

6

1 Identify the deviations

2 Evaluate the deviations

3 Implement CAPA

4 Report the deviations

5 Review the deviations

6 Here’s what else to consider

Quality Management

给文章评分

感谢您的反馈

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