I
Identification Threshold
A limit above (>) which a degradation product should be identified. [ICH Q3A, Q3B]
Identified Degradation Product
A degradation product for which a structural characterisation has been achieved. [ICH Q3B]
Identified Impurity
An impurity for which a structural characterisation has been achieved. [ICH Q3A, Q6A]
Immediate (Primary) Pack
That constituent of the packaging that is in direct contact with the drug substance or drug product, and includes any appropriate label. [ICH Q1B]
Immediate Packaging
The container or other form of packaging immediately in contact with the medicinal product. [Directive 2001/83/EC]
Immediate Release
Allows the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug [ICH Q6A]
Immunological Medicinal Product
Any medicinal product consisting of vaccines, toxins, serums or allergen products:
Impermeable Container
Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed aluminum tubes for semi-solids, sealed glass ampoules for solutions. [ICH Q1A]
Importer
The holder of the authorisation required by Article 40.3 of Directive 2001/83/EC and Article 44.3 of Directive 2001/82/EC for importing medicinal products from third countries. [EU GMP Guide, Annex 16]
Impurity
Any component present in the intermediate or API that is not the desired entity. [EU GMP Guide Part II, ICH Q7]
Any component of the drug substance (bulk material) or drug product (final container product) which is not the chemical entity defined as the drug substance, an excipient, or other additives to the drug product. [ICH Q5C, see also: Q3A, Q3B, Q6A, Q6B]
Impurity Profile
A description of the identified and unidentified impurities present in an API. [EU GMP Guide Part II, ICH Q3A, Q3B, Q7]
In Operation State
The "in operation" state is the condition where the installation is functioning in the defined operating mode with the specified number of personnel working. [EU GMP Guide, Annex 1]
In-house Primary Reference Material
An appropriately characterized material prepared by the manufacturer from (a) representative lot(s) for the purpose of biological assay and physicochemical testing of subsequent lots, and against which in-house working reference material is calibrated. [ICH Q6B]
In-house Working Reference Material
A material prepared similarly to the primary reference material that is established solely to assess and control subsequent lots for the individual attribute in question. It is always calibrated against the in-house primary reference material. [ICH Q6B]
In-line
Measurement where the sample is analysed within the process stream and not removed from it. [Guideline on Process Validation for Finished Products, EMA]
In-process Control
Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control. [EU GMP Guide, Glossary]
(contrôle en cours de fabrication) Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the finished product conforms to its specifications. The control of the production environment or equipment may also be regarded as a part of in-process control. [ICH Q7, Canadian GMP Guidelines 2009]
In-process Drug
(drogue semi-finie) Any material or mixture of materials that must, to become a drug in dosage form, undergo further processing. [Canadian GMP Guidelines 2009]
In-process Material
Any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.[21 CFR Part 210, FDA]
Any material fabricated, compounded, blended, or derived by chemical reaction (e.g., intermediate) that is manufactured for, and used in, the preparation of the phase 1 investigational drug. [Guidance for Industry cGMP for Phase 1 Investigational Drugs, FDA]
In-process Test
Tests which may be performed during the manufacture of either the drug substance or drug product, rather than as part of the formal battery of tests which are conducted prior to release. [ICH Q6A]
In-use Expiry Date
The end of the application period, in which a medicinal product may be taken or applied after the package has been opened, respectively after a first dose of the medicinal product has been taken from the package. [PICS/S PE 010-4]
In-vitro Cell Age
A measure of the period between thawing of the MCB vial(s) and harvest of the production vessel measured by elapsed chronological time in culture, population doubling level of the cells or passage level of the cells when subcultivated by a defined procedure for dilution of the culture [ICH Q5B, Q5A, Q5D]
In-vivo
Procedures conducted in living organisms. [EU GMP Guide, Annex 2]
Inactivation
Removal of infectivity of microorganisms by chemical or physical modification. [ICH Q5A]
Indirect Impact System
This is a system that is not expected to have a direct impact on product quality, but typically will support a direct impact system. These systems are designed and commissioned according to GEP only. [Main Principles for Pharmaceutical Products, WHO]
Industrial Isolator used for Aseptic Processing
Industrial isolators used for aseptic processing are isolators in which the internal space and exposed surfaces are microbiologically controlled. Control is achieved by the use of microbiologically retentive filters, sterilization processes, sporicidal processes (usually by gassing) and prevention of recontamination from the external environment. [PIC/S PI 014-3]
Infiltration
The ingress of contaminated air from an external zone into a clean area. [Main Principles for Pharmaceutical Products, WHO]
Informed Consent (IC)
Decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative. If the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation. [Directive 2001/20/EC]
Innovation
The introduction of new technologies or methodologies. [ICH Q10]
Inspection
see Auditing
Installation Qualification (IQ)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. [EU GMP Guide, Annex 15]
The performance and documentation of tests to ensure that equipment (such as machines, measuring equipment) used in a manufacturing process, are appropriately selected, correctly installed and work in accordance with established specifications. [PIC/S PI 006-3]
(qualification d'installation) The documented act of demonstrating that process equipment and ancillary systems are appropriately selected and correctly installed. [Canadian GMP Guidelines 2009]
Integration Site
The site where one or more copies of the expression construct is integrated into the host cell genome. [ICH Q5B]
Integration Testing
An orderly progression of testing in which software elements, hardware elements, or both are combined and tested until the entire system has been integrated. [PIC/S PI 011-3]
Integrity Test
Test to determine the functional performance of a filter system. [PIC/S PI 007-6]
Interchangeable
Where such status is indicated, any of the official texts from JP, EP, or USP can be substituted one for the other (appropriately referenced) in the ICH regions for purposes of the pharmaceutical registration/approval process. Using any of the interchangeable methods, an analyst will reach the same accept or reject decisions irrespective of which PDG pharmacopeia is used. [ICH Q4B]
Intermediate
Partly processed material which must undergo further manufacturing steps before it becomes a bulk product. [EU GMP Guide, Glossary]
A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) [EU GMP Guide, Part II, see also ICH Q3A]
For biotechnological/biological products, a material produced during a manufacturing process which is not the drug substance or the drug product but whose manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step prior to continuation of the manufacturing process. This includes material which may undergo further molecular modification or be held for an extended period of time prior to further processing. [ICH Q5C]
Intermediate Precision
Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. [ICH Q2]
Intermediate Product
A partly processed material, which should undergo further preparation steps before it becomes a bulk product. [EU GMP Guide, Glossary, PIC/S PE 010-4, Good Distribution Practices for Pharmaceutical Products, WHO, Main Principles for Pharmaceutical Products, WHO]
Intermediate Testing
Studies conducted at 30 °C / 65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25 °C. [ICH Q1A]
Intervention
An aseptic manipulation or activity that occurs at the critical area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Investigational Medicinal Product
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. [Directive 2001/20/EC]
(médicament expérimental) A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. [EU GMP Guide, Annex 13; Canadian GMP Guidelines 2009, Annex 13]
Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [EU GMP Guide, Annex 13]
A doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires. The investigator is responsible for conducting a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator. [Directive 2001/20/EC]
The person responsible for the trial and for protecting the rights, health and welfare of the subjects in the trial. The investigator must be an appropriately qualified person legally allowed to practise medicine/dentistry. [Good Manufacturing Practices: Specific Pharmaceutical Products, WHO]
(chercheur) The person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association, and in any other case, a physician and a member in good standing of a professional medical association. [Canadian GMP-Guidelines, Annex 13]
Investigators Brochure
A compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects. [Directive 2001/20/EC]
Isolator
A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA] A barrier or system that is equiped with Grade B (ISO 5) or even higher cleanness air handling units and can isolate completely the internal environment from external environment (e.g clean room and operators). [Chinese GMP Guidelines, Annex1]
A limit above (>) which a degradation product should be identified. [ICH Q3A, Q3B]
Identified Degradation Product
A degradation product for which a structural characterisation has been achieved. [ICH Q3B]
Identified Impurity
An impurity for which a structural characterisation has been achieved. [ICH Q3A, Q6A]
Immediate (Primary) Pack
That constituent of the packaging that is in direct contact with the drug substance or drug product, and includes any appropriate label. [ICH Q1B]
Immediate Packaging
The container or other form of packaging immediately in contact with the medicinal product. [Directive 2001/83/EC]
Immediate Release
Allows the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug [ICH Q6A]
Immunological Medicinal Product
Any medicinal product consisting of vaccines, toxins, serums or allergen products:
- vaccines, toxins and serums shall cover in particular:
- agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine,
- agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin,
- agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin,
- 'allergen product' shall mean any medicinal product which is intended to identify or induce a specific aquired alteration in the immunological response to an allergizing agent. [Directive 2001/83/EC]
Impermeable Container
Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed aluminum tubes for semi-solids, sealed glass ampoules for solutions. [ICH Q1A]
Importer
The holder of the authorisation required by Article 40.3 of Directive 2001/83/EC and Article 44.3 of Directive 2001/82/EC for importing medicinal products from third countries. [EU GMP Guide, Annex 16]
Impurity
Any component present in the intermediate or API that is not the desired entity. [EU GMP Guide Part II, ICH Q7]
Any component of the drug substance (bulk material) or drug product (final container product) which is not the chemical entity defined as the drug substance, an excipient, or other additives to the drug product. [ICH Q5C, see also: Q3A, Q3B, Q6A, Q6B]
Impurity Profile
A description of the identified and unidentified impurities present in an API. [EU GMP Guide Part II, ICH Q3A, Q3B, Q7]
In Operation State
The "in operation" state is the condition where the installation is functioning in the defined operating mode with the specified number of personnel working. [EU GMP Guide, Annex 1]
In-house Primary Reference Material
An appropriately characterized material prepared by the manufacturer from (a) representative lot(s) for the purpose of biological assay and physicochemical testing of subsequent lots, and against which in-house working reference material is calibrated. [ICH Q6B]
In-house Working Reference Material
A material prepared similarly to the primary reference material that is established solely to assess and control subsequent lots for the individual attribute in question. It is always calibrated against the in-house primary reference material. [ICH Q6B]
In-line
Measurement where the sample is analysed within the process stream and not removed from it. [Guideline on Process Validation for Finished Products, EMA]
In-process Control
Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control. [EU GMP Guide, Glossary]
(contrôle en cours de fabrication) Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the finished product conforms to its specifications. The control of the production environment or equipment may also be regarded as a part of in-process control. [ICH Q7, Canadian GMP Guidelines 2009]
In-process Drug
(drogue semi-finie) Any material or mixture of materials that must, to become a drug in dosage form, undergo further processing. [Canadian GMP Guidelines 2009]
In-process Material
Any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.[21 CFR Part 210, FDA]
Any material fabricated, compounded, blended, or derived by chemical reaction (e.g., intermediate) that is manufactured for, and used in, the preparation of the phase 1 investigational drug. [Guidance for Industry cGMP for Phase 1 Investigational Drugs, FDA]
In-process Test
Tests which may be performed during the manufacture of either the drug substance or drug product, rather than as part of the formal battery of tests which are conducted prior to release. [ICH Q6A]
In-use Expiry Date
The end of the application period, in which a medicinal product may be taken or applied after the package has been opened, respectively after a first dose of the medicinal product has been taken from the package. [PICS/S PE 010-4]
In-vitro Cell Age
A measure of the period between thawing of the MCB vial(s) and harvest of the production vessel measured by elapsed chronological time in culture, population doubling level of the cells or passage level of the cells when subcultivated by a defined procedure for dilution of the culture [ICH Q5B, Q5A, Q5D]
In-vivo
Procedures conducted in living organisms. [EU GMP Guide, Annex 2]
Inactivation
Removal of infectivity of microorganisms by chemical or physical modification. [ICH Q5A]
Indirect Impact System
This is a system that is not expected to have a direct impact on product quality, but typically will support a direct impact system. These systems are designed and commissioned according to GEP only. [Main Principles for Pharmaceutical Products, WHO]
Industrial Isolator used for Aseptic Processing
Industrial isolators used for aseptic processing are isolators in which the internal space and exposed surfaces are microbiologically controlled. Control is achieved by the use of microbiologically retentive filters, sterilization processes, sporicidal processes (usually by gassing) and prevention of recontamination from the external environment. [PIC/S PI 014-3]
Infiltration
The ingress of contaminated air from an external zone into a clean area. [Main Principles for Pharmaceutical Products, WHO]
Informed Consent (IC)
Decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative. If the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation. [Directive 2001/20/EC]
Innovation
The introduction of new technologies or methodologies. [ICH Q10]
Inspection
see Auditing
Installation Qualification (IQ)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. [EU GMP Guide, Annex 15]
The performance and documentation of tests to ensure that equipment (such as machines, measuring equipment) used in a manufacturing process, are appropriately selected, correctly installed and work in accordance with established specifications. [PIC/S PI 006-3]
(qualification d'installation) The documented act of demonstrating that process equipment and ancillary systems are appropriately selected and correctly installed. [Canadian GMP Guidelines 2009]
Integration Site
The site where one or more copies of the expression construct is integrated into the host cell genome. [ICH Q5B]
Integration Testing
An orderly progression of testing in which software elements, hardware elements, or both are combined and tested until the entire system has been integrated. [PIC/S PI 011-3]
Integrity Test
Test to determine the functional performance of a filter system. [PIC/S PI 007-6]
Interchangeable
Where such status is indicated, any of the official texts from JP, EP, or USP can be substituted one for the other (appropriately referenced) in the ICH regions for purposes of the pharmaceutical registration/approval process. Using any of the interchangeable methods, an analyst will reach the same accept or reject decisions irrespective of which PDG pharmacopeia is used. [ICH Q4B]
Intermediate
Partly processed material which must undergo further manufacturing steps before it becomes a bulk product. [EU GMP Guide, Glossary]
A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.) [EU GMP Guide, Part II, see also ICH Q3A]
For biotechnological/biological products, a material produced during a manufacturing process which is not the drug substance or the drug product but whose manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step prior to continuation of the manufacturing process. This includes material which may undergo further molecular modification or be held for an extended period of time prior to further processing. [ICH Q5C]
Intermediate Precision
Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. [ICH Q2]
Intermediate Product
A partly processed material, which should undergo further preparation steps before it becomes a bulk product. [EU GMP Guide, Glossary, PIC/S PE 010-4, Good Distribution Practices for Pharmaceutical Products, WHO, Main Principles for Pharmaceutical Products, WHO]
Intermediate Testing
Studies conducted at 30 °C / 65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25 °C. [ICH Q1A]
Intervention
An aseptic manipulation or activity that occurs at the critical area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Investigational Medicinal Product
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. [Directive 2001/20/EC]
(médicament expérimental) A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. [EU GMP Guide, Annex 13; Canadian GMP Guidelines 2009, Annex 13]
Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [EU GMP Guide, Annex 13]
A doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires. The investigator is responsible for conducting a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator. [Directive 2001/20/EC]
The person responsible for the trial and for protecting the rights, health and welfare of the subjects in the trial. The investigator must be an appropriately qualified person legally allowed to practise medicine/dentistry. [Good Manufacturing Practices: Specific Pharmaceutical Products, WHO]
(chercheur) The person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association, and in any other case, a physician and a member in good standing of a professional medical association. [Canadian GMP-Guidelines, Annex 13]
Investigators Brochure
A compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects. [Directive 2001/20/EC]
Isolator
A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA] A barrier or system that is equiped with Grade B (ISO 5) or even higher cleanness air handling units and can isolate completely the internal environment from external environment (e.g clean room and operators). [Chinese GMP Guidelines, Annex1]