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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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Displaying results 1 - 50 of 53

Action Plan

A written plan consisting of elements to be accomplished to achieve a specific result. The plan describes responsibility for each element and a target date for completion. (TR22)

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Anaerobic Microorganism

A microorganism that does not utilize oxygen as the final electron acceptor during metabolism; microorganism that will grow only in the absence of oxygen. (TR62)(TR22)

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Aseptic Processing

Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69) Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)

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Aseptic Processing Area (APA)

Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)

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Aseptic Processing Simulation (APS)

A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)

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Assess the Effects of the Change

To evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a drug product as those factors may relate to the safety or effectiveness of the drug product. (TR38)

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Attachment (Adhesion)

Discrete association of a microorganism with an animate or inanimate surface. (TR69)

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Attribute

A physical, chemical, or microbiological property or characteristic of an input or output material. (TR60)

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Attributes (Process Performance Attribute)

An output variable or outcome that cannot be directly controlled, but is an indicator that the process performed as expected.(Synonym - Process Performance Parameter) (TR60)

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Attributes (Quality Attribute)

A molecular or product characteristic that is selected for its ability to indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. (TR60)

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Bulk Packaged Product

Consists of solid, liquid, or frozen product in a bulk container configuration such as a bag, tank, or drum. The product may be in these container configurations between process steps or prior to filling into vials, ampoules, cartridges, or syringes. (TR39)

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Changeover

The steps taken for switching multiproduct equipment from the manufacture of one product to the manufacture of a different product. (TR29) (TR49)

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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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Clinical Protocol

A document, together with any amendments to it, that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. (TR63)

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Clinical Trial Material (CTM)

A drug or combination of drugs and/or excipients that are produced with the intent that it be used in a clinical trial, or that is released or otherwise authorized for use in such. This could, subject to appropriate regulatory approval, be an experimental medicine, a product with marketing authorization used in a clinical trial within or beyond the approved indication and/or any placebo articles produced for use in a clinical trial. (TR63)

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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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Closed System

An isolated system that has no interaction with its external environment, preventing contamination and release of the material contained.(TR28) (TR 66)

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Color Changing Unit (CCU)

The quantity of mycoplasma contained in the highest dilution of a test article that produces a color change in a pH-sensitive liquid medium (typically containing phenol red) within a specified time of incubation, used for end-point determination of growth. (TR50)

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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

The quality or state of being suitable for comparison. FDA may determine that two products are comparable if the results of the comparability testing demonstrate that a manufacturing change does not affect identity, strength, quality, purity, or potency as they may relate to the safety or effectiveness of the product. (TR38)

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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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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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Concentration Factor

The ratio of the initial feed volume to the retentate volume. (TR15)

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Concentration Polarization

A phenomenon in which the concentration of retained solutes increases in the region adjacent to the membrane surface due to limitations in particle transport back into the bulk solution. (TR15)

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Container Closure Integrity (CCI)

The ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards.(TR76)

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Critical Process (CP)

A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.

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Defect

(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51) (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)

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Difficult-to-inspect Parenterals (DIP)

When the nature of the product or package limits the ability to perform a thorough inspection for particles. (TR79)

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Excipient

A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4) An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57) Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67) (TR88)

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Extractable

A chemical component that is removed from a material by application of an artificial or exaggerated force (e.g., solvent, temperature, time). The term extractable is often erroneously used to describe a leachable. (TR14) (TR15) (TR26) (TR41) (TR45) Chemical substances that can be extracted from components of material process fluid contact surfaces by exertion of an exaggerated force (e.g., organic solvent, extreme elevated temperature, ionic strength, pH, contact time, etc.) Extractables may represent most but not all of the potential leachables that may be seen in process fluids. (TR66) Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. (TR54-4) Organic or inorganic chemical entity that is forced out of container closure system materials and components under laboratory experimental conditions. (TR73)

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First Expiration, First Out (FeFo)

A method of controlling inventory to ensure that the material with the shortest remaining shelf-life is distributed first. (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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In-Process Observations

Observations or findings that are found during the processing of a product or products.(TR76)

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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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Intrinsic Particles

Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78) A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)

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Leachable

A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)

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Manufacturing

The production, packing, testing, storage, release and distribution of drugs or medical devices for use in humans or animals where the manufacturing is indented to produce doses, typically in significant numbers, for an undefined population of future patients or clinical trial subjects. (TR63) All operations including purchasing and receipt of materials to production, packaging, labelling, quality control, release, storage, distribution of components and the related controls. (TR 76)

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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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Nonconformity (ANSI def.)

A departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement. [Synonym: Defect] (TR43)(TR76)

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Nonconformity Classifications

Critical: A Nonconformity that is likely to result in personal injury or potential hazard to the patient. This classification includes any nonconformity that compromises the integrity of the container, and risks microbiological contamination of a sterile product. Major A: A Nonconformity leading to serious impairments, for example, a malfunction that makes the packaging unusable. Major B: A Nonconformity leading to impairments of a lesser degree, for example, reduced efficiency in production. Minor: A Nonconformity that does not impact product quality or process capability. N/A: An imperfection classification that is less than the size, magnitude and impact of a nonconformity is considered not applicable. Therefore an imperfection that is considered to be non-applicable is acceptable.(TR43) Critical: A nonconformity that risks personal injury or potential hazard to the patient. Any nonconformity that risks container closure in¬tegrity is assigned to this classification. Major A: A nonconformity leading to serious container impairments, e.g., a malfunction making packaging unusable. Major B: A nonconformity leading to contain¬er impairments of a lesser degree, e.g., reduced efficiency in production. Minor: A nonconformity that does not impact product quality or process capability. N/A: Imperfections that are considered to be nonapplicable or nondefects and are therefore acceptable.(TR 76)

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