New Protocols Support Better Instrument Quality Control

The Client

A large, leading manufacturer

The Challenge

The client had to write numerous qualification and validation protocols following a recent FDA inspection. The client was struggling to get the User Requirements Specification (URS documents) and the protocols written and executed, as they did not have the staff to complete such a huge undertaking, nor the budget to hire staff to complete the prject. The client reached out to Actalent to find validation engineers to help support this project because they trusted us to provide the right experts to execute the project. More specifically, the client was looking for validation engineers with experience in writing URS and IQ/OQ/PQ documents, as well as experience in Computer System Validation (CVS) to validate the *instruments' operating system.

Without additional support, the client would have struggled to support the writing and execution of protocols while trying to maintain their rigid manufacturing schedule.

They also would not have been able to have the *documents authored, approved and executed by the FDA deadline, which would have delayed or prevented manufacturing and release testing. As a result, the client would have failed to get their product to market and meet consumer demands, in addition to running the risk of damaging their reputation as a leading manufacturer.

The Actalent Solution

Actalent's goal was to develop a strong team of self-starters with the exact qualifications and abilities critical to the success of the project. Actalent wanted to deploy engineers with excellent communication skills who could understand what each instrument needed from a qualification perspective. These individuals also would have the ability to author comprehensive URS documents and qualification protocols, as well as an understanding of the technical operations and testing requirements per GMPs, 21 CRF part 11 and the client.

The project team Actalent assembled included a validation engineer with five years of experience working with and qualifying analytical instruments. It also included a project manager with over 30 years of experience in quality control, quality assurance and qualifying and validating instruments.

Actalent's technical lead specialized in qualifying analytical instruments, analytical test method validation, HPLC method development and CSV. The validation program lead specialized in analytical instrument qualifications, technical writing, cleaning and process validation, CSV and quality assurance. Both of these team members had over 35 years of combined experience and proven abilities to tackle the qualification and validation protocol work needed.

The Results

Actalent's ability to quickly find and deploy an experienced team of engineers equipped with required skills specified by the client, technical writing, analytical instrument qualification and computer system validation, allowed the client to meet their compliance deadline with the FDA. Actalent's ability to complete the project on time and under budget allowed the client to execute the instrument qualifications and to deliver the required documentation to the FDA in an efficient and timely manner. By meeting this deadline the client avoided further audits and citations from the FDA. They were able to continue manufacturing quality products to meet the demands of their customers and remain on schedule. The client’s reputation as a responsible, quality manufacturer remained intact.

Actalent managed the project remotely so the client could continue their daily manufacturing and testing schedules. Working remotely allowed the client to maintain schedule and it greatly reduced the client's cost of compliance. They client was able to meet with Actalent's team on a weekly basis to stay updated on the project and to provide insight for project needs without hindering manufacturing and release schedules and without the added cost of travel time and expenses.

The client was pleased with Actalent's performance. In the project close out meeting the client stated "We are very pleased and happy to use Actalent's services for the next project as they kept us informed with the progress to ensure our expectations were met."

*The instruments included:

• UV-Vis
• Viscosity Rheometer
• Refractometer
• Moisture Analyzer
• Lab Autoclave
• Luminometer
• Karl Fisher Titrator
• Density Meter
• Air Sampler

*The documents included:

• User Requirement Documents (URS)
• Installation Qualification protocols (IQs)
• Operational Qualification protocols (OQs)
• Performance Qualification protocols (PQs)
• Final Reports