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Full Facility Validation in Eleven Months

 

INDUSTRY

Pharmaceuticals

SERVICES

Commissioning & Qualification
Validation
Facility Set-Up & Inspection

SKILLS

Validation Plan
Development
Seven consultants provided to assist with opening a fully operational facility.

The Challenge

A pharmaceutical manufacturer was facing a challenge: to open a new facility and achieve full validation — from equipment to processes, within the course of a year. However, a lack of resources and a small in-house validation team was hindering their progress. As a result, they decided to seek outside assistance to help them achieve their goals. After vetting several organizations, the client chose Oxford Global Resources to provide the talent they needed due to our proven ability to partner with them and source talent in a short timeframe.

The Solution

After an initial review of the project plan, equipment, and current processes with the client we were able to fully understand the needs of the initiative and provide a comprehensive, customized solution. From there, we established a resource plan to serve the needs of the client and ensure all aspects of the project were addressed.

To increase efficiency and streamline efforts, the project was divided into three phases. The first phase included writing and execution of protocols for various pieces of equipment which included qualification, cleaning verification, and process verification. The second phase involved validating existing equipment, performing cleaning verifications, and process validations for media fill operations. Because the existing facility was being renovated for the client’s use, this included existing equipment re-qualifications and new equipment qualifications. The final phase of the initiative involved validating lab equipment, HVAC system, ISO class 5 and 7 room classifications, and final processes.

It was determined that seven consultants total would be required to get the new facility operational. This team of consultants included a Subject Matter Expert, Project Manager, Validation Engineers, Equipment Engineers, Technical Writers, and QA Support. Through their combined efforts, the following expertise was provided:

  • Engineering Reviews
  • Technical Writing
  • Redevelopment of Work Instructions
  • Overall Equipment and Process Validation
  • Quality Assurance
  • Factory Acceptance Testing
  • Equipment Setup

The Result

Although the expected duration of the project was a full 12 months, our Oxford team was able to help the client achieve full facility validation in 11 months.