Glossary

(ICH Q7) Materials, excluding solvents, used as an aid in the manufacture of an intermediate or API that do not themselves participate in a chemical or biological reaction (e.g. filter aid, activated carbon, etc.).

Tools and systems that utilize real-time measurements, or rapid measurements. It may be used during development or manufacturing of pharmaceuticals to monitor and/or control process parameters.

System for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.

For the purpose of this guidance, PAT is considered to be a system for dsigning, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.

System for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.

The process equipment and the interface, through which is changed, discharged, sampled, intervened, and recovered.

(ICH Q5A (R1)) Viral clearance studies in which non-specific “model” viruses are used to assess the robustness of the manufacturing process to remove and/or inactivate viruses.

Surfaces of process components that, under normal design operating conditions are in direct contact with, or have the potential to come in contact with raw materials, in-process materials, Active Pharmaceutical Ingredients (APIs), clean utilities (e.g., WFI, Pure Steam, CIP solutions, process gases), and where there is a potential for a component (e.g., stoppers) surface to impact drug product(s) strength, identity, safety, purity, and quality.(also see: Product Contact Surfaces)

(also see: In-Process Control)

(ICH Q7)

Location at which the process and the interaction between the environment and the process occurs. ISO 14644-4.

(FDA – 2011) Defining the commercial manufacturing process based on knowledge gained through development and scale-up activities.

(ICH Q5A (R1)) Viral clearance studies in which “relevant” and/or specific “model” viruses are used to determine the ability of the manufacturing process to remove and/or inactivate these viruses.

A detailed and accurate diagrammatic representation (drawing) of the sequential steps required for a specific process and/or utility system through each manufacturing phase.

A schematic of the system which utilizes graphic symbols and text to illustrate the steps of an operation in proper sequence. A PFD should present a detailed, accurate, and ordered flow of raw material or ingredient through each manufacturing phase.

Process gases are defined as gases which can affect product quality.

Environmental limits that, if exceeded, may affect product quality adversely.

Extent of the process range.

Monitors production and either automatically corrects or provides decision support to operators for correcting and improving in-process activities. These activities may be inter-operational and focus specifically on machines or equipment being monitored and controlled, as well as intra-operational, which is tracking the process from one operation to the next. It may include alarm management to make sure factory personnel are aware of process changes that are outside acceptable tolerances. It provides interfaces between intelligent equipment and Manufacturing Execution Systems (MES), possibly through Data Collection/Acquisition.

Possible SQL Injection attack, value has been removed

Head of the production department or nominated deputy.

The person ultimately responsible for the business process or processes being managed.

A process variable (e.g., temperature, compression force) that can be assigned values to be used as control levels or operating limits.

(PDA) A variable that defines or controls a process and can affect the outputs.