EU GMP Chapter 5 - Production

What it says

Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorisations, with particular attention to preventing cross-contamination, ensuring proper material and product identification throughout processing, and validating processes and their critical steps periodically.

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

What it means in practice

• Chapter 5 places strong, explicit emphasis on cross-contamination prevention as a production-wide responsibility, connecting facility design under Chapter 3 with actual production practice and material handling.
• Process validation under this chapter follows a similar lifecycle logic to other EU GMP validation expectations, requiring periodic revalidation rather than treating initial validation as sufficient indefinitely.
• Material and product identification and status throughout production, similar in principle to equipment status labeling under 21 CFR 211.105, is treated as a core production control preventing mix-ups at every processing stage.

What inspectors look for

• Whether cross-contamination prevention measures are visibly and consistently applied during actual production observed during a facility walkthrough, not just described in procedure.
• Whether process validation, including periodic revalidation, is current for the processes and products being manufactured.
• Whether material and product status is clearly and consistently identified at every stage of production, from receipt through to finished product.

Related regulations