Definition

In the EU, a person legally responsible for certifying that each batch of product has been manufactured and tested in compliance with GMP and the MA. Must meet defined education and training requirements.

Example

The QP performs batch certification before release; failure to have a named QP can suspend the licence.

Regulatory source

Directive 2001/83/EC, 2001/82/EC

Common mistakes

QP certifying without having personally verified compliance. Delegating certification in a way that breaches legal duties.

Inspector question

How does the QP verify compliance before certification? Show batch release records.

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