International Forum on Process Analytical Chemistry - IFPAC

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Glossary

1

PAT (Process Analytical Technology)

A regulatory framework, set out in the FDA's 2004 PAT guidance, for designing, analysing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw materials and processes. At IFPAC, PAT is the organising theme: sessions and exhibitors cover in-line analysers, control strategies and the validation evidence regulators expect.

2

QbD (Quality by Design)

A systematic approach to development that starts from predefined objectives and builds product and process understanding from risk assessment and experimental data. IFPAC sessions track how QbD design spaces translate into control strategies that plant teams can actually run.

3

Design space

The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality. Exhibitors and speakers discuss how design space boundaries are verified with PAT data rather than end-product testing alone.

4

CQA (Critical Quality Attribute)

A physical, chemical, biological or microbiological property that must stay within an approved limit to ensure product quality. Method selection at IFPAC usually starts from the CQA list, then asks which attribute can be measured in process instead of in the QC lab.

5

CPP (Critical Process Parameter)

A process variable whose variability has a measurable impact on a CQA and therefore must be monitored or controlled. PAT deployments shown at the meeting typically pair analyser output with CPP control loops.

6

Chemometrics

The multivariate statistical methods (PCA, PLS and related models) used to turn spectral or multi-sensor data into actionable measurements. It is a recurring IFPAC track because model maintenance, transfer and validation are where most PAT projects succeed or stall.

7

NIR spectroscopy

Near-infrared spectroscopy used in process for moisture, blend uniformity, content uniformity and reaction endpoint. NIR probes and model libraries are among the most common hardware on the IFPAC exhibition floor.

8

Raman spectroscopy

A vibrational technique suited to polymorph identification, reaction monitoring and aqueous or glass-packed processes where NIR struggles. Raman vendors at IFPAC typically present probe interfaces and chemometric models validated for GMP use.

9

Real-time release testing (RTRT)

Replacing end-product testing with in-process measurement and model-based assurance that the batch meets specification. It depends on validated PAT methods and control strategies, which is why RTRT appears in both regulatory and engineering sessions at IFPAC.

10

Continuous manufacturing

Integrated flow-based production using feeders, blenders, extruders and tablet presses in a linked line. IFPAC covers the analyser placement, residence time and control-loop questions that determine whether a continuous line can be validated and released in real time.

11

Residence time distribution (RTD)

The spread of material residence times through a continuous process unit. RTD models link in-line measurement at a probe point to the material actually leaving the line, and they are a standard discussion topic for continuous manufacturing exhibitors.

12

Soft sensor

A model that infers a hard-to-measure property from easier measurements such as temperature, pressure or spectra. Soft sensors and AI-based predictive models are increasingly presented as a way to extend PAT coverage without adding hardware at every step.

13

ICH Q8-Q12

The ICH quality guidelines covering pharmaceutical development, risk management, quality systems, process development and lifecycle management. IFPAC speakers reference them because a PAT control strategy has to sit inside a Q8-Q12 filing rather than beside it.

14

Data integrity and 21 CFR Part 11

The US rules on electronic records and signatures that govern how analyser software stores, audits and signs data. Almost every PAT software vendor on the IFPAC floor has to explain audit trails, user access control and model versioning against these requirements.