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How to fill out out-of-specification results - gmp-navigator

Point by point, here is how to fill out out-of-specification results on the GMP-Navigator platform:

1. Access the GMP-Navigator platform by logging in with your credentials.
2. Once logged in, navigate to the "Out-of-Specification" section or module within the platform.
3. Select the option to create a new out-of-specification result entry.
4. Provide the necessary information for the out-of-specification result, such as the product or sample name, batch number, and date of analysis.
5. Fill in the observed out-of-specification result value or parameter, along with the associated specification limits.
6. If applicable, provide any additional details or comments regarding the out-of-specification result.
7. Attach any supporting documentation or evidence, such as laboratory test reports or analysis data.
8. Review the filled-out out-of-specification result form for accuracy and completeness.
9. Save or submit the out-of-specification result entry as per the platform's instructions.

Who needs out-of-specification results on the GMP-Navigator platform:

1. Quality Assurance Department: The Quality Assurance department needs access to out-of-specification results to assess the compliance of products and take necessary actions, such as initiating investigations or implementing corrective measures.
2. Manufacturing Department: The Manufacturing department requires out-of-specification results to identify any potential production issues or deviations from specifications.
3. Regulatory Authorities: Regulatory authorities may ask for out-of-specification results from pharmaceutical or manufacturing companies as part of their regulatory compliance activities or inspections.
4. Management: The management team of a company needs access to out-of-specification results to review the overall quality performance and make informed decisions regarding product release or rejections.
5. Auditors: Internal or external auditors may need to review out-of-specification results to assess the effectiveness of the company's quality management system and compliance with GMP regulations.

For pdfFiller’s FAQs

What is out-of-specification results - gmp-navigator?

Out-of-specification results refer to test results that fall outside the accepted criteria or specifications outlined in the GMP-navigator guidelines.

Who is required to file out-of-specification results - gmp-navigator?

All parties involved in the testing and analysis of pharmaceutical products are required to file out-of-specification results in accordance with GMP-navigator regulations.

How to fill out out-of-specification results - gmp-navigator?

Out-of-specification results should be filled out by providing detailed information about the test conducted, the results obtained, the potential reasons for the deviation, and any corrective actions taken.

What is the purpose of out-of-specification results - gmp-navigator?

The purpose of out-of-specification results is to ensure the quality and efficacy of pharmaceutical products by identifying and addressing any deviations from the specified criteria.

What information must be reported on out-of-specification results - gmp-navigator?

The information that must be reported on out-of-specification results includes the test conducted, the results obtained, the acceptance criteria, any deviations observed, potential reasons for the deviation, and any corrective actions taken.

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