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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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C Validation

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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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Chamber Leak Test

A test conducted to evaluate possible air infiltration to the chamber under vacuum. [Synonym: Vacuum Leak Test] (TR1) (TR48)

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Change Control

A formal program that describes evaluation and actions to be taken if a change is proposed or completed to facilities, materials, equipment, and/or processes used in the fabrication, packaging, and testing of drugs, or a proposed or completed change that may affect the operation of the quality or support systems. (TR22) (TR39) (TR52) (TR58) (TR64) (TR 70)

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Characterization Study

A series of tests designed to increase process knowledge by examining proposed operational ranges and their individual and/or combined impact on the chromatography process. (TR14) A late-stage study that evaluates the process to increase process knowledge and examines proposed operational ranges and their individual and/or combined impact on target protein quality. (TR42)

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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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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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Cold Chain

A temperature- and time-controlled supply chain for products (e.g., refrigerated products typically have a temperature storage range of 2 °C to 8 °C). (TR58)

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Cold Chain Tolerance Groups

This concept expands the “normal” definition of cold chain to include all products that need to be stored below 250C and also introduces the ancillary terms “ambient temperatures” and “controlled ambient”. (TR46)

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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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Component, Primary

Element of the assembled prefilled syringe (needle, plunger stopper and tip closure, or adhesive) directly in contact with the drug. (TR 73)

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Component, Secondary

Element of the assembled prefilled syringe (plunger rod, backstop, or safety system) that interacts with the primary components and provides functionality to the delivery system. (TR 73)

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Composite Membrane

A membrane consisting of multiple layers. (TR15)

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Compounding

A process in which a bulk drug substance is combined with one or more excipients and/or another bulk drug substance to produce a drug product. (TR22) A process wherein bulk drug substance is combined with one or more excipients and/or another bulk drug substance to produce a drug product. (TR62) The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following: • Preparation of drug dosage forms for both human and animal patients • Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns • Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients • Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis • Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law. (TR63)

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Concurrent Validation

Validation that occurs during manufacturing of drug substance for batches that can be released and used in a final drug product for commercial distribution based on thorough monitoring and heightened testing of the drug substance batches. (TR42)

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Condenser

Component that removes the heat absorbed by the refrigerant from the compressor and temperature- controlled area. (TR64)

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Conformance Batches/Lots

A pre-determined number of production lots, typically three, that represent the process and are evaluated to demonstrate consistency. [Synonyms: validation, consistency, demonstration lots, qualification lots] (TR14) (TR42)

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Contact Time

The minimum amount of time that a sanitizer, disinfectant, or sporicide must be left in complete (wet) contact with the surface to be treated in order to be effective. (TR70)

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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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Container Cold Spot

The location within a sealed liquid container that achieves the lowest process lethality (F0) during a sterilization process. (TR01)

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Contaminants (Contamination)

Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product (16). The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API [drug substance] during production [manufacture], sampling, packaging or repackaging, storage or transport (17).

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Continued Process Verification (CPV)

Assuring that during routine production the process remains in a state of control. (TR60) US FDA: Assuring that during routine production the process remains in a state of control. ICH: An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. (TR60-2)

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Continuous Manufacturing

At least two process unit operations conducted under predetermined control conditions without process interruptions, where real-time process controls (PATs) may be used to meet the process requirements.

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Continuous Process Verification

An alternative approach to process Validation in which manufacturing process performance is continuously monitored and evaluated. (TR60)

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Continuum of Criticality (As Used for Attributes)

Following comprehensive assessments of scientific evidence and risk, quality attributes are ranked according to the degree of criticality. The continuum, as opposed to binary classifications of Critical and Non-Critical, is thought to “more accurately reflect complexity of structure-function relationships and the reality that there is some uncertainty around attribute classification”. (TR60)

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Continuum of Criticality (As Used for Parameters)

A non-discrete scale where parameters or attributes are evaluated relative to their impact on drug substance and drug product quality. (TR60)

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Control Strategy

A planned set of controls, derived from current product and process understanding, which ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (TR 54) (TR 60) (TR 54-5) (TR56)

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Controlled Environmental Space (CES)

An area that is controlled by regulating temperature. (TR64)

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Controlled Room Temperature (CRT)

Defined by USP <1079> as the usual and customary working environment of 20 °C to 25 °C (68 - 77 F) that allows for deviations between 15 °C and 30 °C (59 - 86 F) based on stability data. (TR58)

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Cool-Down Phase

The phase of a sterilization cycle that occurs after completion of the exposure phase. Parameters of a cool-down phase are typically defined in order to meet applicable user requirements for load cooling and drying. (TR01) The phase of a sterilization cycle that occurs after completion of the exposure phase. [Synonym: post-conditioning phase, slow exhaust phase, drying phase, equalization phase] (TR48) The phase of an SIP cycle that occurs after completion of the exposure phase. Parameters (e.g., time, temperature, pressure) of a cool-down phase are typically defined in order to meet applicable user requirements for system cooling and drying. (TR61)

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Correction

Repair, rework, or adjustment relating to the disposition of an existing deviation. (TR88)

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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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Correlation Coefficient ( r )

A measure of covariation, the square root of the coefficient of determination. (TR57)

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Coupon

A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)

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Coverage

The appropriate distribution of a chemical agent needed on the equipment surface to be effective. (TR70)

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Critical Area/Critical Zone

An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas. (TR13) (TR22) (TR44) (TR62)

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Critical Control Point

A step at which control can be applied and that is essential to prevent or eliminate a pharmaceutical quality hazard or reduce it to an acceptable level. (TR54-4) (TR61)

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Displaying results 1 - 50 of 59