• Mar 5, 2024
  • Quality Assurance and Methods Compliance
  • By Amy Ganden

Supplier Qualification of Your Contract Laboratory

Do you need to audit your contract laboratories as part of your supplier qualification process? Qualifying new vendors can be a labor-intensive, frustrating process with the answers you need oftentimes difficult to obtain. Our team at Particle Technology Labs strives to make your supplier qualification smooth and efficient, assisting you with whatever help you need.

What type of supplier qualification support does PTL offer?

PTL’s quality and laboratory systems can be evaluated via:

  • Provision of PTL’s current ISO/IEC 17025:2017 accreditation certificate, FDA registration and the Establishment Inspection Report from our most recent FDA inspection
  • Completion of a client-provided quality questionnaire
  • On-site one day facility audit
  • Remote one day facility audit
  • Client-provided quality agreements, master service agreements and confidentiality agreements can be reviewed and executed.

 
To start qualification of PTL as your preferred particle characterization vendor, please send us a message.

What is the process to schedule an audit?

PTL’s sales staff will forward your audit inquiry to our experienced audit team. Our audit hosts will work with you to schedule your one-day audit of the PTL facility. The format, whether on-site or remote, is determined by the client based on their requirements. Prior to the audit, basic information such as accreditation certificates, registrations, organizational charts and procedure indices can be shared if requested.

What can you expect during your on-site audit of PTL?

The goal of the audit is to build a trusted, supported relationship between PTL and the client. The audit day is framed around the client’s needs and what their auditors wish to experience and see.

Typically, the day begins with an opening meeting between the PTL audit hosts, PTL quality management and the client auditors. This meeting establishes a foundational understanding of Particle Technology Labs’ history, offerings and business overview. The audit day will proceed into a laboratory facility tour including the sample receipt and storage areas where the auditor will be provided an overview of project and sample movement through the PTL lifecycle. Auditors have direct access to the laboratories to see the instruments of interest, discuss the techniques used with technical staff and get a feel for the laboratory systems and controls in place at PTL. Throughout the tour, laboratory staff are available to answer questions and provide information.

For the remainder of the day, auditors spend their time reviewing PTL’s quality systems – such as procedures, analytical records, training records, instrument qualifications and maintenance records – to provide evidence PTL indeed follows established procedures and fulfills regulatory requirements. Throughout the day, auditors are encouraged to ask questions and discuss concerns or questions that arise. PTL strives to help each client understand how we manage and control our quality systems, analytical results and client relationships.

At the conclusion of the audit day, a closing meeting is held to formally review observed strengths and opportunities for improvement. It is our hope that through the audit process we will gain insight into our client’s requirements and needs while they, in turn, achieve an understanding of PTL’s processes to establish a high level of trust and confidence in our analytical services.

What support is offered by PTL after an audit?

PTL’s quality team continues to support our clients after the completion of the audit. Any valid observations will be addressed proactively and corrected to ensure PTL’s systems comply with current quality expectations and requirements. In addition, we will continue to be a resource for any future quality needs. Our team is always on the ready to help assist you: we are always one message away. Contact us today with your supplier qualification needs!

By Amy Ganden, Quality Assurance and Methods Compliance Manager.