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What are the best ways to validate GMP technology in manufacturing operations?

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GMP technology is essential for ensuring quality, safety and compliance in manufacturing operations. However, implementing new or updated technology requires careful validation to verify that it meets the intended specifications and performance. Validation is a systematic process that involves planning, testing, documenting and reviewing the results of each phase. In this article, you will learn about the best ways to validate GMP technology in manufacturing operations, based on the following steps:

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Saul Favela, PMP

Manufacturing | PMP | LSSBB | PhD Student in Technology | PhD Student in Mechatronics Engineering | Polymath |…
Saleh Saeed Mohammed Ali

Quality |Production |R&D |Manufacturing Manger |FMCG

1 Define the scope and objectives

The first step is to define the scope and objectives of the validation project, including the technology to be validated, the intended use and the regulatory requirements. You should also identify the stakeholders, roles and responsibilities, deliverables and timelines for the project. A clear and detailed scope and objectives will help you to avoid unnecessary or redundant work, manage expectations and risks, and align the validation activities with the business goals.

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Saul Favela, PMP

Manufacturing | PMP | LSSBB | PhD Student in Technology | PhD Student in Mechatronics Engineering | Polymath | Knowledge Broker | MES R&D
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It is very important to define the scope and objectives of the validation project in a Master Validation Plan (MVP). Depending on the SOP placed in each organization regarind the implementation of validation process, the MVP could include the protocols IQ, OQ, and PQ, reports and deviations. Basically, your MVP will direct your efforts in the validation process.

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2 Develop the validation plan and protocols

The next step is to develop the validation plan and protocols, which are the documents that describe how the validation will be conducted, what criteria will be used to evaluate the results, and how the data will be recorded and reported. The validation plan and protocols should follow the relevant guidelines and standards, such as the FDA's General Principles of Software Validation or the ISPE's GAMP 5. The validation plan and protocols should also define the validation stages, such as design qualification, installation qualification, operational qualification and performance qualification, and the acceptance criteria for each stage.

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Saul Favela, PMP

Manufacturing | PMP | LSSBB | PhD Student in Technology | PhD Student in Mechatronics Engineering | Polymath | Knowledge Broker | MES R&D
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SOPs for validation process should be in place to avoid redundancy over information and tasks. Templates and forms should help engineers to facilitate these tasks. Also, remember that not all the equipment and machines have the same way or method of validation; it would depends of the intent of the equipment/machines in the manufacturing process.

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3 Execute the validation tests

The third step is to execute the validation tests, which are the activities that demonstrate that the technology functions as intended and meets the specifications and performance requirements. The validation tests should follow the validation protocols and use appropriate methods, tools and equipment. The validation tests should also be performed by qualified personnel, under controlled conditions, and with adequate documentation and traceability. The validation tests should cover all the relevant aspects of the technology, such as functionality, reliability, security, usability and compatibility.

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Saul Favela, PMP

Manufacturing | PMP | LSSBB | PhD Student in Technology | PhD Student in Mechatronics Engineering | Polymath | Knowledge Broker | MES R&D
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Validation tests are part of the scientific method: you will use objective evidence to prove your hypothesis. Determine the best method and technique to analyze data, and don't forget to use validated and calibrated equipment to perform your tests.

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4 Analyze and report the validation results

The fourth step is to analyze and report the validation results, which are the outcomes of the validation tests and the evidence that the technology is validated. The validation results should be compared with the acceptance criteria and analyzed for any deviations, errors or discrepancies. The validation results should also be reported in a clear, concise and consistent manner, using formats such as validation summary reports or certificates of validation. The validation results should also be reviewed and approved by the authorized parties, such as the validation team, the quality assurance team or the regulatory authorities.

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5 Implement and monitor the technology

The fifth step is to implement and monitor the technology, which are the actions that ensure that the technology is integrated into the manufacturing operations and maintained in a validated state. The implementation and monitoring of the technology should follow the change management and risk management processes, as well as the standard operating procedures and good documentation practices. The implementation and monitoring of the technology should also involve regular verification, calibration, maintenance and audit activities, as well as feedback and improvement mechanisms.

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6 Update the validation as needed

The sixth step is to update the validation as needed, which are the modifications that reflect any changes or enhancements to the technology or the requirements. The update of the validation should follow the same steps as the initial validation, but with a proportionate and risk-based approach. The update of the validation should also be documented and communicated to the relevant stakeholders, and comply with the regulatory obligations.

By following these steps, you can validate GMP technology in manufacturing operations effectively and efficiently, and ensure that you deliver high-quality products and services to your customers and stakeholders.

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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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Saul Favela, PMP

Manufacturing | PMP | LSSBB | PhD Student in Technology | PhD Student in Mechatronics Engineering | Polymath | Knowledge Broker | MES R&D
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Validation process is a shared effort and activity where different departments in the organization work: engineering, manufacturing, quality, and management.

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Saleh Saeed Mohammed Ali

Quality |Production |R&D |Manufacturing Manger |FMCG
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the best way to validate GMP technology in manufacturing operations is use the GMP technology in a way that is consistent with the quality of the product. This can be done by: Validation of cleaning and sanitation procedures: This can be done by testing surfaces for the presence of residues of cleaning agents or microorganisms. Validation of sterilization procedures: This can be done by using biological indicators to test the effectiveness of the sterilization process. Validation of equipment: This can be done by testing the equipment to ensure that it is operating within the specified parameters. Validation of computer systems: This can be done by testing the systems to ensure that they are meeting the requirements of the GMP regulations.

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What are the best ways to validate GMP technology in manufacturing operations?

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3

4

5

6

7

1 Define the scope and objectives

2 Develop the validation plan and protocols

3 Execute the validation tests

4 Analyze and report the validation results

5 Implement and monitor the technology

6 Update the validation as needed

7 Here’s what else to consider

Manufacturing Operations

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What are the best ways to validate GMP technology in manufacturing operations?

1

2

3

4

5

6

7

1 Define the scope and objectives

2 Develop the validation plan and protocols

3 Execute the validation tests

4 Analyze and report the validation results

5 Implement and monitor the technology

6 Update the validation as needed

7 Here’s what else to consider

Manufacturing Operations

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