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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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Adverse Event (AE) Report

An AE report is a communication to the U.S. FDA of an undesirable sign or symptom associated with use of a drug as required and detailed by 21 CFR 314.80. These reports are logged into the U.S. FDA’s Adverse Event Reporting System (AERS). Drug manufacturers are required to report adverse event information to FDA. These reports may also may be voluntarily submitted to the FDA directly by healthcare professionals or the general public at Med Watch. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by the Center for Drug Evaluation and Research (CDER). (TR55)

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Adverse Trend

A series of alert-level or action-level excursions that indicates the system or areas are not in control and have the potential to affect the product quality. (TR 70) An increase in the frequency of alert- and action-level excursions or repeated recovery of low levels of microorganisms below the alert level during microbial monitoring or of pharmaceutical ingredient or finished product failure that is indicative of a loss of process control. (TR88)

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Aggregation

Clumping of proteins, viruses, or bacteria that may arise from several mechanisms and may be classified in numerous ways, including soluble/insoluble, covalent/noncovalent, reversible/irreversible, and native/denatured. (TR47)

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Aspect Ratio

The length of a particle or fiber divided by its width. (TR85)

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Batch Record Review

Review by the quality control unit of the batch manufacturing record for accuracy and completeness and for absence of derivation from the approved manufacturing and testing processes. The batch record is inclusive of all in-process testing and release records for a batch. (TR88)

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Biomethylation

The enzyme chlorophenol o-methyltransferase responsible for fungal methylation has been isolated in cell-free extracts. Biomethylation, in this context, may be seen as a detoxification mechanism, although it plays a role in the production of mycotoxins by secondary metabolism. Slightly xerophilic fungi frequently associated halophenol biomethylation include Trichoderma longibrachiatum, Trichoderma virgatum, Aspergillus sydowii, and Penicillium islandicum. (TR55)

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Calibration Curve

The relationship between measured response values and analytical concentrations of a standard or reference material. (TR57)

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Capsule

A self-contained filter device. (TR45)

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Capsule Filter

Compact, self-contained filter assembly. Generally, the whole assembly is disposable. (TR26) (TR41)

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Carrier

A solid support upon which the test organism used in biological monitoring is inoculated. (TR51)

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Cartridge Filter

Filter elements encased in a housing. Generally, the filter elements are disposable while the housing units are multi-use. In a few cases, both filter and housings are disposable. (TR26) (TR41)

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Class I Recall

A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. (TR55)

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Class II Recall

A situation in which use of or exposure to a violative product or may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.(TR55)

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Clean

Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49) The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)

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Clean in Place (CIP)

The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)

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Clean(liness)

The measurement for the level of particulates, microbes, or other extraneous substances on an item or surface. (TR 70)

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Cleaning Validation

Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)

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Cleaning Verification

A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)

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Clinician

A physician, psychiatrist, etc., who specializes in clinical work as opposed to one engaged in laboratory or experimental studies. (TR58)

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Commissioning

A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases: 1. Inspection, testing, and regulation 2. Adjustment and setting of work 3. Functional testing (TR 3) A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48) A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)

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Comparability Protocol

A protocol submitted by an applicant under CFR 601.12(e) and 314.70 (g) that describes the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, and potency of the product as they may relate to the safety or effectiveness of the product. Any such protocols, or change to a protocol, shall be submitted as a supplement requiring approval from FDA prior to distribution of the product. The supplement, if approved, may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect. (TR38)

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Comparability Study

An assessment of the similarities between the critical parameters and output results of two or more separate processes or methods. (TR50)

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Comparative Transfer

Transfer of a method that involves the analysis of a predetermined number of samples of the same lot by both the sending and the receiving unit. (TR 57-2)

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Compatibility

Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26) A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)

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Compatibility (Filter)

The ability of a filter to be used with a particular process fluid without a change in the inherent properties of the filter. (TR41)

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Compendial Procedure

A method that is considered validated as published in one of the recognized compendia. (TR57)

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Complaint Files

(a) As defined by 21 CFR Part 211.198- Complaint Files. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. 1.The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant .2.Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180. (TR55)

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Corrective Action and Preventative Action (CAPA)

Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5) A subsystem used to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective measures to prevent recurrence of the identified problem (8). (TR88)

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Decision Maker(s)

Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)

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Extemporaneous Preparation (EP)

A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)

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FDA Form 483

Inspectional observation sheet used by FDA investigators to document their findings. (TR67)

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Fault Tree Analysis (FTA)

A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)

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Historical Data

For purposes of this guidance, data on impurities or physical attributes from three or more consecutive, representative pre-modification batches. (TR38)

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ISO/IEC

International Organization for Standardization/International Electrotechnical Commision. (TR52)

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Implants

Implants are long-acting dosage forms that provide continuous release of an API for periods of months to years. They are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or, for local delivery, they can be placed in a specific region in the body. (TR79)

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Incident

Any event that occurs during the shelf life of a product that may have an adverse effect on quality (e.g., temperature excursion, missing temperature monitor when required, shipment time in excess of qualified packout duration, wet/ crushed packaging). (TR58)

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Incident Management System

Part of the Quality Management System that handles incidents, deviations, excursions, and exceptions in the supply chain. (TR58)

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Incoming Inspection

A preventative program where parts or products are subjected to evaluation upon receipt.(TR43) A program where, upon receipt, parts or products are subjected to measuring, examining, testing, or gauging one or more characteristics of a product or service, and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.(TR 76)

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Justification

Reports containing scientific data and expert professional judgment to substantiate decisions. (TR38)

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Lot or Batch

A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits.(TR76)

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Manual Baseline

Data generated from visual inspection of a blinded set of seeded test containers that demonstrates the detection capability of human inspection. The test set is sometimes referred to as a “particle size threshold set,” where various foreign particulate types in a gradation of sizes are examined to yield a statistically significant probability of detection percentage for each unit. This allows the determination of what types and sizes of particulates can be reproducibly detected in a specific product/container system. (TR79)

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Material Safety Data Sheet (MSDS)

Information provided with chemicals and other materials intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner. Includes information such as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill-handling procedures. (TR65)

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Method Comparability

The demonstration of analytical method comparability (AMC) for method replacements. A study to demonstrate that a modification to an existing method either improves or does not significantly change the analytical procedure’s characteristics relative to the methods’ validation and intended use. (TR57)

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Powders

Powders are defined as a solid or a mixture of solids in a finely divided state intended for internal or external use. Powders used as pharmaceutical dosage forms may contain one or more APIs and can be mixed with water for oral administration or injection. (TR79)

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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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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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Semiautomated Inspection

Consists of machine-assisted handling and presentation of filled containers to allow for human visual inspection. (TR79)

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Subject Matter Experts (SMEs)

Individuals with specific technical expertise such as engineers, quality experts, automation specialists, scientists, etc. (TR54-5)

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Supplemental Testing or Inspection

Destructive reconstitution, dilution, transfer, clearing, solubilizing, filtration, screening, or sieving that allows a product to be visually examined or evaluated microscopically to determine the presence, type, and size of foreign particulate contamination present within the product, container, or device. (TR79)

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Tyndall Lighting

Collimated lighting at right angle to the viewing direction, typically against a black or dark background, which is useful during manual visual inspection to detect fine dispersions of small particulate that scatter the light making them more detectable. (TR79)

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