Commissioning, qualification and validation (CQV) is a complex process. Over the years CQV has become Adryan’s strategic flagship.

Commissioning ensures that facilities, systems and equipment are designed and installed as specified and that they function as intended. Commissioning is the managed and planned process of bringing a facility, system or equipment from its installed or constructed state into operational service.

Qualification ensures that equipment and systems function to produce products correctly. Qualification is a process of providing assurance and documented evidence that specific facilities, systems, or equipment meet predetermined acceptance criteria and are ready for the intended use.

Validation applies to processes and procedures, and it’s purpose is to demonstrate that the processes, equipment, methods, tests, and activities involve they can repeatedly produce the desired product. For that reason, each critical step in the manufacturing process must be validated, as it must be verified that these steps perform as intended under defined conditions.

Integrated commissioning and qualification

Adryan’s approach to commissioning and qualification is based on the cGMP requirements and ASTM E2500 method.

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Cleaning validation

The approach of Adryan as member of a subject matter expert team will help you to identify the cleaning validation issues that could affect patient safety or product quality.

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Analytical method validation

Adryan’s approach to analytical method validation is based on the cGMP requirements and ICH Q2 guidelines.

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Design qualification

Adryan’s approach will help the suppliers to identify the design issues that could affect patient safety or product quality.

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Computerized system validation

Computerized systems must be qualified in order to address the specific security and data integrity risks, besides the operational risks.

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Essential document preparation

The experts of Adryan can provide assistance in creating essential written documents.

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Process validation

The process validation engineers of Adryan are able to assure that your qualified equipment and personnel, and the process as well as its process controls are consistently able to produce your product in line with patient safety requirements.

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Any life sciences company needs to follow processes in order to comply with the applicable standards, laws and regulations.

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Engineers use scientific principles to make sure projects can be executed in a safe manner with the expected level of quality. Engineers are involved in phases such as basis of design, testing and maintenance of products and systems.

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The practice of project management within the highly regulated pharmaceutical industry provides unique challenges and opportunities.

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