Who Should Sign Quality Agreement

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However, the FDA guidelines state that quality agreements should cover activities that fall under Part 820 of the 21 CFR, the Quality System Regulation (QSR) for medical device companies, “where applicable.” Taking into account the inclusion of Part 820 in the Guidelines, a quality agreement between a medical device company and a CMO should address the following aspects to varying degrees, depending on the nature of the relationship between the two parties and the products and services concerned: Quality agreements should be prepared by the quality assurance (QA) functions of both parties. involve relevant operating personnel such as manufacturing and laboratory personnel. They must be approved by the quality assurance function of both parties and the operations department of both parties. The legal department may or may not be involved in the quality agreement.

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