The terms that matter in an audit.

The user-side requirement spec: defines what a plant or system must do. The basis of every qualification; it must be testable, unambiguous and traceable.

Documented evidence that the planned design meets the URS requirements, before construction.

Evidence that the plant and system are installed in accordance with the specification.

Evidence that the system functions as intended across its entire operating range.

Evidence that the system performs reliably and reproducibly under real operating conditions.

Integrated approach that brings technical commissioning and regulatory qualification together (leveraging), instead of testing twice.

Risk-based, periodic evidence that a system maintains the validated state. Annex 15 deliberately names no rigid interval, but requires a justified determination.

A lifecycle in three stages: Process Design, Process Qualification (PPQ) and Continued Process Verification (CPV). Does not end with three successful batches.

Risk- and science-based standard for verifying plants and systems. The basis for integrated C&Q.

Revised EU-GMP guideline (2022, in force since 2023) for the manufacture of sterile medicinal products. Puts the Contamination Control Strategy at the centre.

A facility-wide, documented strategy bringing together all contamination-relevant measures: from personnel and gowning to monitoring. Not a binder document, but a living management instrument.

Classification of air cleanliness by particle and microbial count. Class A is the most critical zone for aseptic processes.

Barrier technology that separates the product from the operator (Restricted Access Barrier System or isolator). Annex 1 expects it for aseptic processes.

Aseptic Process Simulation: filling with growth medium instead of product to qualify the aseptic process and the personnel.

Ongoing monitoring of particles and microorganisms in the cleanroom, with trending. What matters is not the volume of data, but its significance.

Umbrella term for the «Good x Practice» regulations: GMP (Manufacturing), GLP (Laboratory), GCP (Clinical), GDP (Distribution).

Good Manufacturing Practice: the binding rules for the manufacture and testing of medicinal products. The «c» stands for «current».

ISPE guide for the risk-based validation of computerised systems. The 2nd edition emphasises Critical Thinking over form-filling.

Documented evidence that a computerised system is fit for its purpose and safeguards data integrity. Effort scales with patient risk and GxP impact.

Risk-based FDA approach that focuses testing effort where patient risk exists: less documentation, more assurance.

Principles of data integrity: Attributable, Legible, Contemporaneous, Original, Accurate, plus complete, consistent, enduring, available.

Secure, time-stamped record of the creation, change and deletion of GxP-relevant data. Must be reviewed on a risk basis, not merely recorded.

Regulations on computerised systems and electronic records: EU-GMP Annex 11 and US-FDA 21 CFR Part 11.

Completeness, consistency and trustworthiness of data across the entire lifecycle. Created at the outset through design, not at the end through inspection.

Media and supply systems (water, cleanroom air, gases) that determine product quality behind the scenes. Rarely in the spotlight, until they fail.

The highest pharmaceutical water quality, for injectables. Qualified in three phases and monitored microbiologically.

Purified water for non-sterile applications. Likewise qualified and monitored with trending.

Heating, Ventilation, Air Conditioning: controls cleanroom class, pressure cascades and recovery times. Drifts when filter loading and air flows are not readjusted.

Transfer of a process from laboratory to production scale under GMP. What works in the lab does not automatically work at full scale.

Guideline on Quality Risk Management. The basis for risk-based decisions, for example on alarm and action limits.

Corrosion film in stainless-steel water systems. Goes unnoticed without regular inspection and undermines system integrity.