D
D Value
The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Debugging
The process of locating, analysing, and correcting suspected faults. [PIC/S PI 011-3]
Decision Maker
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions. [ICH Q9]
Decontamination
A process that eliminates viable bioburden via use of sporicidal chemical agents. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Dedicated
(dédié) Facility or piece of equipment used only in the fabrication of a particular product. [Canadian GMP Guidelines, Annex 2]
(réservé) Facility or piece of equipment used only in the fabrication of a particular product or a closely related group of products. [Canadian GMP Guidelines, Annex 3, Annex 5]
Degradation Product
An impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system. [ICH Q3B]
A molecule resulting from a change in the drug substance (bulk material) brought about over time. For the purpose of stability testing of the products described in this guideline, such changes could occur as a result of processing or storage (e.g., by deamidation, oxidation, aggregation, proteolysis). For biotechnological/biological products some degradation products may be active. [ICH Q5C]
A molecule resulting from a chemical change in the drug molecule brought about over time and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Also called decomposition product. [ICH Q6A]
Molecular variants resulting from changes in the desired product or product-related substances brought about over time and/or by the action of, e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Such changes may occur as a result of manufacture and/or storage (e.g., deamidation, oxidation, aggregation, proteolysis). Degradation products may be either product-related substances, or product-related impurities. [ICH Q6B]
Degradation Profile
A description of the degradation products observed in the drug substance or drug product. [ICH Q3B]
Delayed Release
Release of a drug (or drugs) at a time other than immediately following oral administration. [ICH Q6A]
Depyrogenation
A process used to destroy or remove pyrogens (e.g., endotoxin). [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Design Condition
Design condition relates to the specified range or accuracy of a controlled variable used by the designer as a basis for determining the performance requirements of an engineered system. [Main Principles for Pharmaceutical Products, WHO]
Design History File
Compilation of records which describes the design history of a finished [medical] device. [21 CFR Part 820, FDA]
Design Input
The physical and performance requirements of a [medical] device that are used as a basis for device design. [21 CFR Part 820, FDA]
Design Output
The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the [medical] device, its packaging and labeling, and the device master record. [21 CFR Part 820, FDA]
Design Qualification (DQ)
The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose. [EU GMP Guide, Annex 15]
Documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of good manufacturing practices (GMP). [TRS 961 Annex 7, WHO]
Design Review
A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. [21 CFR Part 820, FDA]
Design Space
The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. [ICH Q8]
Design Validation
Establishing by objective evidence that device specifications conform with user needs and intended use(s). [21 CFR Part 820, FDA]
Desired Product
Detectability
The ability to discover or determine the existence, presence, or fact of a hazard. [ICH Q9]
Detection Limit
The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value. [ICH Q2]
Detoxification
(détoxification) Conversion of bacterial toxins to toxoids (non-toxic but immunogenic derivatives of toxins) by chemical treatment. [Canadian GMP Guidelines, Annex 2]
Development Study
Studies conducted to scale-up, optimise, and validate the manufacturing process for a drug product. [ICH Q3B]
Deviation / Discrepancy
Departure from an approved instruction or established standard. [EU GMP Guide Part II, ICH Q7]
Failure to meet a critical limit. [Hazard and Risk Analysis, WHO]
Datum or result outside of the expected range, an unfulfilled requirement, may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Deviation Report
A deviation report is a report of any deviation from standard procedures and documentation that occurs during the preparation process, and consequent remedial action. [PIC/S PE 010-4]
Device History Record
A compilation of records containing the production history of a finished [medical] device. [21 CFR Part 820, FDA]
Device Master Record (DMR)
A compilation of records containing the procedures and specifications for a finished [medical] device. [21 CFR Part 820, FDA]
Dilute Drug Premix
A drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. [Canadian GMP Guidelines 2009, Annex 4]
Diploid Cell Line
A cell line having a finite in vitro lifespan in which the chromosomes are paired (euploid) and are structurally identical to those of the species from which they were derived. [ICH Q5D]
Direct Donation
Blood collected from an individual for the purpose of transfusion to a different individual, named by the donor, who has been identified in advance to be compatible. [Canadian GMP Guidelines, Annex 14]
Direct Impact System
A system that is expected to have a direct impact on product quality. These systems are designed and commissioned in line with good engineering practice (GEP) and, in addition, are subject to qualification practices. [Main Principles for Pharmaceutical Products, WHO]
Discrepancy
see Deviation
Disinfection
Process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Distribution
The procuring, purchasing, holding, storing, selling, supplying, importing, exporting, or movement of pharmaceutical products, with the exception of the dispensing or providing pharmaceutical products directly to a patient or his or her agent. [Good Distribution Practices for Pharmaceutical Products, WHO]
Document Submission
The working documents received from the PDG or one or more pharmacopoeial sources (USP, Ph. Eur., or JP) that contain the proposed pharmacopoeial text and any other support documents provided for Q4B evaluation. [ICH Q4B]
Donor
The person who donates the cells or tissue that serves as the raw materials for the cell/tissue-based drugs (excluding those concerned with the body of a brain-dead person specified in Paragraph 2 of Article 6 of Law on Organ Transplantation (Law No. 104, 1997)). [Japan MHLW Ministerial Ordinance No. 179, 2004]
Donor Animal
The animal which provides the cells or tissue that serves as the raw materials for the cell/tissue-based drugs. [Japan MHLW Ministerial Ordinance No. 179, 2004]
Dosage Form
A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients. [ICH Q1A]
Drug Identification Number
(drogue: identification numérique) A number assigned to each drug in dosage form under the Food and Drug Regulations with the exception of blood and blood components and radiopharmaceuticals. [Canadian GMP Guidelines 2009]
Drug Master File (DMF)
Detailed information concerning a specific facility, process or product submitted to the medicines regulatory authority, intended for incorporation into the application for marketing authorization. [TRS 961 Annex 7, WHO]
Drug Premix / Medicated Premix
A drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (C.01A.001 of the Food and Drugs Regulations). It is a veterinary drug product prepared in advance with a view to the subsequent manufacture of medicated feeds. [Canadian GMP Guidelines, Annex 4]
Drug Product
The dosage form in the final immediate packaging intended for marketing. [ICH Q1A]
A pharmaceutical product type that contains a drug substance, generally, in association with excipients. [ICH Q6B]
A finished dosage form (e.g., tablet, capsule, solution) that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient, but is intended to be used as a placebo. [FDA Guidance for Industry cGMP for Phase 1 Investigational Drugs, 21 CFR 210, FDA]
A pharmaceutical product type that contains a biological drug substance, generally in association with excipients. It corresponds to the dosage form in the immediate packaging intended for marketing (also called dosage form, finished product, final container product). [Canadian GMP Guidelines 2009, Annex 2]
Drug Substance (bulk material)
(see also Active Pharmaceutical Ingredient) The material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers. [ICH Q6B]
Dynamic
Conditions relating to clean area classification under conditions of normal production. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Debugging
The process of locating, analysing, and correcting suspected faults. [PIC/S PI 011-3]
Decision Maker
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions. [ICH Q9]
Decontamination
A process that eliminates viable bioburden via use of sporicidal chemical agents. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Dedicated
(dédié) Facility or piece of equipment used only in the fabrication of a particular product. [Canadian GMP Guidelines, Annex 2]
(réservé) Facility or piece of equipment used only in the fabrication of a particular product or a closely related group of products. [Canadian GMP Guidelines, Annex 3, Annex 5]
Degradation Product
An impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system. [ICH Q3B]
A molecule resulting from a change in the drug substance (bulk material) brought about over time. For the purpose of stability testing of the products described in this guideline, such changes could occur as a result of processing or storage (e.g., by deamidation, oxidation, aggregation, proteolysis). For biotechnological/biological products some degradation products may be active. [ICH Q5C]
A molecule resulting from a chemical change in the drug molecule brought about over time and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Also called decomposition product. [ICH Q6A]
Molecular variants resulting from changes in the desired product or product-related substances brought about over time and/or by the action of, e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Such changes may occur as a result of manufacture and/or storage (e.g., deamidation, oxidation, aggregation, proteolysis). Degradation products may be either product-related substances, or product-related impurities. [ICH Q6B]
Degradation Profile
A description of the degradation products observed in the drug substance or drug product. [ICH Q3B]
Delayed Release
Release of a drug (or drugs) at a time other than immediately following oral administration. [ICH Q6A]
Depyrogenation
A process used to destroy or remove pyrogens (e.g., endotoxin). [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Design Condition
Design condition relates to the specified range or accuracy of a controlled variable used by the designer as a basis for determining the performance requirements of an engineered system. [Main Principles for Pharmaceutical Products, WHO]
Design History File
Compilation of records which describes the design history of a finished [medical] device. [21 CFR Part 820, FDA]
Design Input
The physical and performance requirements of a [medical] device that are used as a basis for device design. [21 CFR Part 820, FDA]
Design Output
The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the [medical] device, its packaging and labeling, and the device master record. [21 CFR Part 820, FDA]
Design Qualification (DQ)
The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose. [EU GMP Guide, Annex 15]
Documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of good manufacturing practices (GMP). [TRS 961 Annex 7, WHO]
Design Review
A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. [21 CFR Part 820, FDA]
Design Space
The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. [ICH Q8]
Design Validation
Establishing by objective evidence that device specifications conform with user needs and intended use(s). [21 CFR Part 820, FDA]
Desired Product
- The protein which has the expected structure, or
- the protein which is expected from the DNA sequence and anticipated post-translational modification (including glycoforms), and from the intended downstream modification to produce an active biological molecule. [ICH Q6B]
Detectability
The ability to discover or determine the existence, presence, or fact of a hazard. [ICH Q9]
Detection Limit
The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value. [ICH Q2]
Detoxification
(détoxification) Conversion of bacterial toxins to toxoids (non-toxic but immunogenic derivatives of toxins) by chemical treatment. [Canadian GMP Guidelines, Annex 2]
Development Study
Studies conducted to scale-up, optimise, and validate the manufacturing process for a drug product. [ICH Q3B]
Deviation / Discrepancy
Departure from an approved instruction or established standard. [EU GMP Guide Part II, ICH Q7]
Failure to meet a critical limit. [Hazard and Risk Analysis, WHO]
Datum or result outside of the expected range, an unfulfilled requirement, may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Deviation Report
A deviation report is a report of any deviation from standard procedures and documentation that occurs during the preparation process, and consequent remedial action. [PIC/S PE 010-4]
Device History Record
A compilation of records containing the production history of a finished [medical] device. [21 CFR Part 820, FDA]
Device Master Record (DMR)
A compilation of records containing the procedures and specifications for a finished [medical] device. [21 CFR Part 820, FDA]
Dilute Drug Premix
A drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. [Canadian GMP Guidelines 2009, Annex 4]
Diploid Cell Line
A cell line having a finite in vitro lifespan in which the chromosomes are paired (euploid) and are structurally identical to those of the species from which they were derived. [ICH Q5D]
Direct Donation
Blood collected from an individual for the purpose of transfusion to a different individual, named by the donor, who has been identified in advance to be compatible. [Canadian GMP Guidelines, Annex 14]
Direct Impact System
A system that is expected to have a direct impact on product quality. These systems are designed and commissioned in line with good engineering practice (GEP) and, in addition, are subject to qualification practices. [Main Principles for Pharmaceutical Products, WHO]
Discrepancy
see Deviation
Disinfection
Process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Distribution
The procuring, purchasing, holding, storing, selling, supplying, importing, exporting, or movement of pharmaceutical products, with the exception of the dispensing or providing pharmaceutical products directly to a patient or his or her agent. [Good Distribution Practices for Pharmaceutical Products, WHO]
Document Submission
The working documents received from the PDG or one or more pharmacopoeial sources (USP, Ph. Eur., or JP) that contain the proposed pharmacopoeial text and any other support documents provided for Q4B evaluation. [ICH Q4B]
Donor
The person who donates the cells or tissue that serves as the raw materials for the cell/tissue-based drugs (excluding those concerned with the body of a brain-dead person specified in Paragraph 2 of Article 6 of Law on Organ Transplantation (Law No. 104, 1997)). [Japan MHLW Ministerial Ordinance No. 179, 2004]
Donor Animal
The animal which provides the cells or tissue that serves as the raw materials for the cell/tissue-based drugs. [Japan MHLW Ministerial Ordinance No. 179, 2004]
Dosage Form
A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients. [ICH Q1A]
Drug Identification Number
(drogue: identification numérique) A number assigned to each drug in dosage form under the Food and Drug Regulations with the exception of blood and blood components and radiopharmaceuticals. [Canadian GMP Guidelines 2009]
Drug Master File (DMF)
Detailed information concerning a specific facility, process or product submitted to the medicines regulatory authority, intended for incorporation into the application for marketing authorization. [TRS 961 Annex 7, WHO]
Drug Premix / Medicated Premix
A drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (C.01A.001 of the Food and Drugs Regulations). It is a veterinary drug product prepared in advance with a view to the subsequent manufacture of medicated feeds. [Canadian GMP Guidelines, Annex 4]
Drug Product
The dosage form in the final immediate packaging intended for marketing. [ICH Q1A]
A pharmaceutical product type that contains a drug substance, generally, in association with excipients. [ICH Q6B]
A finished dosage form (e.g., tablet, capsule, solution) that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient, but is intended to be used as a placebo. [FDA Guidance for Industry cGMP for Phase 1 Investigational Drugs, 21 CFR 210, FDA]
A pharmaceutical product type that contains a biological drug substance, generally in association with excipients. It corresponds to the dosage form in the immediate packaging intended for marketing (also called dosage form, finished product, final container product). [Canadian GMP Guidelines 2009, Annex 2]
Drug Substance (bulk material)
(see also Active Pharmaceutical Ingredient) The material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers. [ICH Q6B]
Dynamic
Conditions relating to clean area classification under conditions of normal production. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]