EU GMP Chapter 6 - Quality Control

What it says

Quality control must be independent of production, with adequate facilities, trained personnel and approved procedures for sampling, testing and monitoring, and sufficient authority to ensure no material is released or rejected other than by the systems established by the manufacturer.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Chapter 6 establishes quality control independence in a manner closely paralleling quality unit independence expectations under 21 CFR 211.22, reflecting a shared underlying principle across both frameworks despite different specific provision structures.
• This chapter covers the full analytical testing lifecycle expectations, sampling, testing, retained samples and stability, in one consolidated chapter rather than distributed across many separate provisions.
• Quality control's authority over release and rejection decisions is explicit and absolute under this chapter - no other function can override or bypass the established quality control release system.

What inspectors look for

• Whether quality control genuinely operates independently of production influence in practice, not just in organisational structure.
• Whether quality control has sufficient resources and authority to prevent release decisions being made outside its established systems.
• Whether the full scope of quality control responsibilities described in this chapter, sampling, testing, stability and retained samples, functions as one connected system.

Related regulations