Glossary

A processing variable (temperature, pressure, pH, etc.) associated with a processing operation.

A system for the monitoring of process performance and product quality to ensure a state of control is maintained.

(FDA) Establishing confidence that the process is effective and reproducible.

(FDA – 2011) Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing.

Specified range within which the process should operate.

Risk Assessment to systematically review the process, unit operation by unit operation, so that the critical unit operation(s), and hence critical process step(s), can be identified.

The extent to which the process operating conditions and raw materials can vary while continuing to assure the required product quality.

An attempt to view any production process and identify if steps can be removed without negatively impacting the overall process.

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A process step generally includes one or more unit operations. The output of a process step is either an API or an intermediate.

The established capacity of the manufacturing process to produce effective and reproducible results consistently.

Systems that do not contact product and are generally engineered systems.

Systems that directly support the process operations.

Systems which either are in contact with the drug substance in its purified or unpurified state, or in contact with the materials (that) which will ultimately become, or be in contact with the drug substance.

Systems that may contact the drug substance or could otherwise directly impact product quality.

Any technology required to convert raw materials into finished product and package the product for delivery.

Process Validation(FDA – 2011) The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

A documented program that provides a high degree of assurance that a specific process will consistently produce a result meeting the pre- determined acceptance criteria.

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (characteristics).

Documented plan for testing a pharmaceutical product that confirms that the production process used to manufacture the product performs as intended. This includes a review of process variables and operational limitations as well as providing the sampling plan under actual use conditions.

(ICH Q6B) Impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or column leachables).

A process/system critical instrument is an instrument whose accuracy/failure may have a direct effect on process or system performance without affecting final product quality, or safety.

Any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.

Prescribed value for process critical parameters, including the process “recipe”.