Medical device quality agreement

In the medical devices, pharmaceutical and life sciences industries, there is a growing tilt towards contract manufacturing. This is done by organizations that perceive benefits in the form of increased ROI and operational ease. In the process of getting these works carried out, organizations have to ensure that their quality and other traits are maintained. In order to make sure that these are present, a medical device quality agreement becomes necessary.

What is a medical device quality agreement?

We can understand a medical device quality agreement as a formal document that defines the terms of engagement between the supplier and the contractor (sponsor) the sets out the ways in which pre-defined quality processes are going to be laid out and monitored. This is necessary as medical devices and products of the pharmaceutical and life sciences require a high degree of scientific precision, which have to be ensured no matter where and by whom they are manufactured. The product has to also meet regulatory requirements, since this cannot be compromised on.

Shared responsibility

The foundation of a medical device quality agreement is the level of similarity the product brings when it is manufactured by the supplier. Since a medical device quality agreement involves both the parties, its benefits and pitfalls are mutual and shared. The reputation of both the supplier and the sponsor is at stake, and both are equally responsible for the product outcome and quality. The medical device quality agreement should state the extent to which this is going to operate during the contract.

In which areas are medical device quality agreements done?

A medical device quality agreement is done in relation to the following among related areas:

  • Maintenance, qualification and validation activities
  • GMP audits by third parties
  • Label printing
  • Release activities
  • Storage and transport

References:

http://www.mastercontrol.com/newsletter/quality_agreements_1209.html

http://www.asqlongisland.org/seminars/QualityAgreements-Bailey2005.pdf

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