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7 Steps to Establishing a Validated cGMP facility

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When a scientist leaves a big pharma company and ventures out on their own, they may want to establish their own cGMP facility to produce products for sale in both domestic and foreign markets. Following are the recommended steps to establishing a validated cGMP facility.

1. Conduct a risk assessment (FMEA – failure, mode, effect, analysis) on the proposed location. Some factors that may affect the building selection include limits on roof loads or power available for the building. Site restrictions can include capacity of utilities, and proper zoning.

2. The owner / user must then create a “User Requirement Specification Document” (based on scientist intended use of the facility). The URS document will be the basis for subsequent system design, configuration, testing, and validation deliverables. From this document, flow charts, sequence of operations and a forecast of work and allocation of resources can be created. This information is needed prior to beginning design work or identifying needed equipment.

3. At this point it is time to build a team and enlist professionals with experience in business acumen – engineering, construction, validation, etc. This team can translate user specifications as necessary to accomplish assigned multiple tasks.

4. Now it is time to design / redesign the facility utilizing the engineering and construction team. The facility is then constructed and commissioned, e.g. start up has begun.

5. Finally the lab is ready for validation. A review of commissioning and start up activities is performed. A master validation plan is created; validation and various protocols are established. A master validation summary report is created post validation activities.

6. The facility is now operational. The owner / users ensure the validated state of the facility is maintained throughout its operational life. This includes the creation of programs that support change control, periodic review of manufacturing operations and maintenance, as well as calibration of equipment, and constant monitoring.

7. Annual re-validation and periodic review programs must be written, approved, and exercised as necessary to ensure compliance.

It is important to understand that the validation is specific for the initial use or product it was designed for. If in the future the scientist wishes to produce a variation from the initial validated process such as a different size or type of product then a change control must be issued. The proposed changes must be validated prior to use.

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