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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

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Rapid Microbiological Methods (RMMs; Alternative Microbiological Methods)

Technologies that allow users to obtain microbiology test results more quickly than traditional microbiological methods, which are usually culture/ growth based. (TR69)

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Raw Data (FDA)

Any laboratory worksheets, records, memoranda, notes, or exact copies thereof that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.(TR80)

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Raw Data (MHRA)

The original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state.(TR80)

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Raw Materials

Starting materials, reagents, and solvents used in the production of intermediates or APIs/drug substance. (TR54-4) (TR83)

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Rect A

The longest side length when a rectangle is constructed around the particle. (TR85)

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Redundant Filtration

A type of serial filtration in which a second sterilizing-grade filter is used as a backup in the event of an integrity failure of the primary sterilizing filter. (TR26)

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Reference Strain

A well characterized, widely accepted preparation of viable organisms that is used to validate a microbiological assay. (TR50)

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Registration Stability Lots

The lots of drug substance manufactured to establish the stability profile in support of the regulatory filing. (TR56)

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Reportable result

The final analytical result. This result is defined in the written approved test method and derived from one full execution of that method, starting from the original sample. (TR57)

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Requalification

Periodic confirmation to demonstrate that equipment performance has not changed from its qualified state. (TR3)

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Reserve/Reference Samples

An appropriately identified reserve sample that is representative of each lot of intermediate product and in each shipment of each active ingredient shall be retained (at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications; this is a regulatory Requirement). (TR56)

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Residual Risk

Risk remaining after risk control measures have been taken. (TR44) (TR58) Risk remaining after risk control measures have been implemented (derived from ISO 14971:2007). (TR54) (TR54-2) Risk remaining after risk control measures has been implemented. (TR54-5)

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Restricted Access Barrier System (RABS)

RABS are aseptic processing systems (ISO 5) intended to substantially reduce human borne contamination within the aseptic environment where sterile product, containers, closures and equipment are exposed by the use of separative devices and defined mechanical features and operating procedures. (TR22) (TR62) Aseptic processing systems (ISO 5) intended to substantially reduce human-borne contamination within the aseptic environment where sterile product, containers, closures, and equipment are exposed by the use of separative devices and defined mechanical features and operating procedures. (TR13)

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Retain (Retention) Samples

Intermediate and final and finished product samples that are stored for the intent of repeating any in-process or release analysis. Typically this is twice the amount of material that is required to perform these. (TR56)

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Retrospective Process Validation

Validation of an existing manufacturing process that occurs by reviewing data from relevant historical and test production records. (TR14) (TR42)

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Revalidation

Repeating partial or full validation of a process after a process change is implemented. Re-validation is change-based, not time-based. (TR14) (TR3) (TR42)

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Rework

Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent). (TR74)

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Risk

The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)

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Risk Acceptance

The decision to accept risk (ISO Guide 73). (TR54) (TR54-2) (TR58)

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Risk Analysis

The estimation of the risk associated with the identified hazards. (TR13) (TR30) (TR44) (TR54) (TR54-2) (TR58) (TR54-5)

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Risk Assessment

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards. (TR30) (TR44) (TR54) (TR58) (TR55) (TR67) (TR57-2) (TR54-5) (TR88)

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Risk Control

Items in place and/or actions to implement risk management decisions. (TR44) Actions implementing risk management decisions. (TR54-2) (TR54-5) (TR84)

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Risk Evaluation

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk (TR30) (TR54-2) (TR44) (TR58) (TR54-5)

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Risk Identification

The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.(TR44) (TR54-2) (TR58) (TR54-5)

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Risk Management

The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)

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Risk Management Report

Report that summarizes the outcomes of the QRM process. (TR54) (TR54-2) (TR54-5)

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Risk Mitigation

Active systematic steps taken to reduce or limit risk. (TR55) (TR67)

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Risk Prioritization Number (RPN)

A quantitative method for determining the level of risk by multiplying the severity, occurrence and detectability rankings of the failure or event. (TR44) The Risk Priority Number, or RPN, is a numeric assessment of risk assigned to a process, or steps in a process, as part of Failure Modes and Effects Analysis (FMEA), in which a team assigns each failure mode a numeric values that quantifies likelihood of occurrence, likelihood of detection, and severity of impact. (TR54-4) A quantitative measure used when assessing the level of risk. (TR54-5)

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Risk Prioritization Ranking (RPR)

A qualitative method for determining the level of risk by combining severity, occurrence and detectability rankings of the failure or event. (TR44)

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Risk Priority Level

A relative priority ranking assigned to a risk based on a combination of a) therapeutic use of a product and patient impact due to product unavailability, b) availability of alternatives, and c) likelihood of a shortage. (TR68)

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Risk Priority Number (RPN)

A quantitative measure used when assessing the level of risk. (TR54-2) The product of severity (S), occurrence (O) and detection (D) used to determine the significance of the risk. (TR54-3)

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Risk Reduction

The process of decreasing the level of risk. (TR44) Process for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level (e.g., reduce severity, probability of harm, and improves detectability of hazards and quality risks). (TR58) Actions taken to lessen the probability of occurrence of harm and the severity of that harm. (TR54-2) (TR54-5)

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Risk Review

An ongoing monitoring of events, output and results of the risk management process that takes into account new knowledge and experience. [A] step in the risk management process for taking in account of new knowledge and experiences. (TR44) (TR58) Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk. (TR54-2) (TR54-5)

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Risk-based Triage for Drug Shortages

A process of assessing and assigning priorities for managing drug shortage risks based on criticality and impact to patients (TR68)

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Robustness

The measure of capacity to remain unaffected by small, but deliberate, variations in method parameters and provides an indication of its reliability during normal usage. (TR57) (TR33)

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Root Cause Analysis (RCA)

An evaluation conducted for the purpose of identifying the cause of the deviation or non-conformance. (TR52)

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Routine Operational Process

Parameters that are specified for ongoing operations. The operational process is typically controlled to produce additional lethality over the qualified minimum parameters (i.e., time and temperature) in order to provide increased sterility assurance. (TR3)

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Ruggedness

The degree of intermediate precision or reproducibility of test results obtained by assessing the same samples under a variety of normal test conditions. (TR33)