The contract laboratory sector has seen enormous growth over the past two decades, largely from providing specialty testing to full-service contract manufacturing and development. However, locating an organization that can support your project in a cost-effective manner is only the start of the process. We can help find a laboratory and navigate you through the complex issues of development testing, manufacturing and release.
We can provide services in the following laboratory management areas.
In today’s business climate, there are many laboratory options, from small specialty firms to full-service testing and manufacturing. The qualification process is a comprehensive, holistic approach to assessing the overall quality of the laboratory and is an essential part of any quality system. It provides documented verification that a facility complies with your specific requirements, and it can produce an analytical product meeting your specific standards.
The qualification areas include, but are not limited to the following
Qualification is just one step in the larger quality picture. Ongoing inspections are necessary to ensure the laboratory remains in compliance with state and federal laws, and continues to provide you with a quality process and product.
Whereas the qualification process is a holistic approach, inspections should focus on detailed and targeted areas that are critical to the success of your product.
Inspections are conducted to determine the degree of conformity with GxP Principles. They assure that resulting data are of adequate quality for assessment and decision-making by National Regulatory Authorities. They result in a report that describes the degree of compliance with GxP Principles and should be conducted on a routine basis.
Study audits are designed to review on-going or completed studies and maybe requested by Regulatory Authorities. The objective should be to reconstruct the study by comparing interim and final reports to the study protocol, relevant SOPs, raw data and other archived material.
The audits should be conducted throughout the lifespan of a study to ensure that data is being collected, analyzed and reported according to the study protocol. They should be performed before any inspection by Regulatory Authorities to ensure that any deviations are properly investigated, documented and resolved.
Data integrity refers to the completeness, consistency, and accuracy of the data. The data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate (ALCOA).
To establish data integrity, organizations must take steps to protect original data from accidental or intentional modification, falsification, or deletion. Whether data is recorded in paper or electronic formats, or a hybrid of both, the FDA requires the data to comply with the principles of ALCOA. In our increasing reliance on storage systems, such as cloud based storage, it is imperative to establish how data is collected, stored, protected and retrieved.