E
Electrodeionisation (EDI)
(CDI = Continuous Deionisation, EDI = Electrodeionisation) A desalination process based on electrodialysis and mixed bed technology.
Electronic Signature
(see also Advanced Electronic Signature)
An electronic measure that can be substituted for a handwritten signature or initials for the purpose of signifying approval, authorisation or verification of specific data entries. [PIC/S PI 011-3]
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [21 CFR Part 11, FDA]
Embedded System
A system, usually microprocessor or PLC based, whose sole purpose is to control a particular piece of automated equipment. This is contrasted with a standalone computer system. [PIC/S PI 011-3]
Enabler
A tool or process which provides the means to achieve an objective. [ICH Q10]
Enantiomer
Compounds with the same molecular formula as the drug substance, which differ in the spatial arrangement of atoms within the molecule and are non-superimposable mirror images. [ICH Q6A]
Enantiomeric Impurity
A compound with the same molecular formula as the drug substance that differs in the spatial arrangement of atoms within the molecule and is a non-superimposable mirror image. [ICH Q3A]
Endogenous Virus
Viral entity whose genome is part of the germ line of the species of origin of the cell line and is covalently integrated into the genome of animal from which the parental cell line was derived. For the purposes of this document, intentionally introduced, non-integrated viruses such as EBV used to immortalise cell substrates or Bovine Papilloma Virus fit in this category. [ICH Q5A]
Endotoxin
A pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Enhanced Approach
A development approach where risk management and scientific knowledge ist used to identify and understand the material attributes and process parameters which influence the critical quality attributes of a product. [Guideline on Process Validation for Finished Products, EMA]
Enterprise Resource Planning System (ERPS)
ERP systems belong to the company management levels with strategic, commercial tasks with a longer-term time frame. The most widely used ERP system is SAP.
Environmental Monitoring Programme
Defined documented programme which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded. [PIC/S PI 007-6]
Ethics Committee
An independent body in a Member State, consisting of healthcare professionals and nonmedical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent. [Directive 2001/20/EC]
Evacuate
To remove the residual gas from a container/system to a pressure less than 1.013 bar, using a vacuum system. [EU GMP Guide, Annex 6]
Ex-Vivo
Where procedures are conducted on tissues or cells outside the living body and returned to the living body. [EU GMP Guide, Annex 2]
Excipient
Any constituent if a medicinal product other than the active substance and the packaging material. [Directive 2011/62/EU]
Anything other than the drug substance in the dosage form. [ICH Q1A]
An ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used. [ICH Q6B]
Auxiliary materials used in the preparation of biological medicinal products, e.g., adjuvants, stabilisers, excipients. [Chinese GMP Guidelines, Annex 3]
Executive Program
A computer program, usually part of the operating system, that controls the execution of other computer programs and regulates the flow of work in a data processing system. [PIC/S PI 011-3]
Exotic Organism
A biological agent where either the corresponding disease does not exist in a given country or geographical area, or where the disease is the subject of prophylactic measures or an eradication programme undertaken in the given country or geographical area. [EU GMP Guide, Glossary]
Expiry Date / Expiration Date
(see also Shelf-Life)
The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used. [EU GMP Guide Part II, ICH Q7]
The date placed on the container label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification if stored under defined conditions, and after which it must not be used. [ICH Q1A]
The date given on the individual container (usually on the label) of a pharmaceutical product/drug product up to and including the date on which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
The end of the shelf life period, in non-coded form, after which the medicinal product should not be used. Also called the use before date. [PIC/S PE 010-4]
(date limite d’utilisation) Means the earlier of (a) the date, expressed at minimum as a year and month, up to and including which a drug maintains its labelled potency, purity and physical characteristics, and (b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the drug not be used.” C.01.001) [Canadian GMP Guidelines 2009]
Export Procedure
Allow Community goods to leave the customs territory of the Union. For the purpose of these guidelines, the supply of medicines from EU Member State to a contracting State of the European Economic Area is not considered as export. [EU GDP Guidelines]
Expression Construct
The expression vector which contains the coding sequence of the recombinant protein and the elements necessary for its expression. [ICH Q5B]
Extemporaneous Preparation
A product, which is dispensed immediately after preparation and not kept in stock. [PIC/S PE 010-4]
Extended Release
Products which are formulated to make the drug available over an extended period after administration. [ICH Q6A]
Extraneous Contaminant
An impurity arising from any source extraneous to the manufacturing process. [ICH Q3A]
(CDI = Continuous Deionisation, EDI = Electrodeionisation) A desalination process based on electrodialysis and mixed bed technology.
Electronic Signature
(see also Advanced Electronic Signature)
An electronic measure that can be substituted for a handwritten signature or initials for the purpose of signifying approval, authorisation or verification of specific data entries. [PIC/S PI 011-3]
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [21 CFR Part 11, FDA]
Embedded System
A system, usually microprocessor or PLC based, whose sole purpose is to control a particular piece of automated equipment. This is contrasted with a standalone computer system. [PIC/S PI 011-3]
Enabler
A tool or process which provides the means to achieve an objective. [ICH Q10]
Enantiomer
Compounds with the same molecular formula as the drug substance, which differ in the spatial arrangement of atoms within the molecule and are non-superimposable mirror images. [ICH Q6A]
Enantiomeric Impurity
A compound with the same molecular formula as the drug substance that differs in the spatial arrangement of atoms within the molecule and is a non-superimposable mirror image. [ICH Q3A]
Endogenous Virus
Viral entity whose genome is part of the germ line of the species of origin of the cell line and is covalently integrated into the genome of animal from which the parental cell line was derived. For the purposes of this document, intentionally introduced, non-integrated viruses such as EBV used to immortalise cell substrates or Bovine Papilloma Virus fit in this category. [ICH Q5A]
Endotoxin
A pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Enhanced Approach
A development approach where risk management and scientific knowledge ist used to identify and understand the material attributes and process parameters which influence the critical quality attributes of a product. [Guideline on Process Validation for Finished Products, EMA]
Enterprise Resource Planning System (ERPS)
ERP systems belong to the company management levels with strategic, commercial tasks with a longer-term time frame. The most widely used ERP system is SAP.
Environmental Monitoring Programme
Defined documented programme which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded. [PIC/S PI 007-6]
Ethics Committee
An independent body in a Member State, consisting of healthcare professionals and nonmedical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent. [Directive 2001/20/EC]
Evacuate
To remove the residual gas from a container/system to a pressure less than 1.013 bar, using a vacuum system. [EU GMP Guide, Annex 6]
Ex-Vivo
Where procedures are conducted on tissues or cells outside the living body and returned to the living body. [EU GMP Guide, Annex 2]
Excipient
Any constituent if a medicinal product other than the active substance and the packaging material. [Directive 2011/62/EU]
Anything other than the drug substance in the dosage form. [ICH Q1A]
An ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used. [ICH Q6B]
Auxiliary materials used in the preparation of biological medicinal products, e.g., adjuvants, stabilisers, excipients. [Chinese GMP Guidelines, Annex 3]
Executive Program
A computer program, usually part of the operating system, that controls the execution of other computer programs and regulates the flow of work in a data processing system. [PIC/S PI 011-3]
Exotic Organism
A biological agent where either the corresponding disease does not exist in a given country or geographical area, or where the disease is the subject of prophylactic measures or an eradication programme undertaken in the given country or geographical area. [EU GMP Guide, Glossary]
- A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to:
- aid in the processing of the drug delivery system during its manufacture,
- protect, support or enhance stability, bioavailability, or patient acceptability,
- assist in product identification, or
- enhance any other attribute of the overall safety and effectiveness of the drug during storage or use. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
Expiry Date / Expiration Date
(see also Shelf-Life)
The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used. [EU GMP Guide Part II, ICH Q7]
The date placed on the container label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification if stored under defined conditions, and after which it must not be used. [ICH Q1A]
The date given on the individual container (usually on the label) of a pharmaceutical product/drug product up to and including the date on which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
The end of the shelf life period, in non-coded form, after which the medicinal product should not be used. Also called the use before date. [PIC/S PE 010-4]
(date limite d’utilisation) Means the earlier of (a) the date, expressed at minimum as a year and month, up to and including which a drug maintains its labelled potency, purity and physical characteristics, and (b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the drug not be used.” C.01.001) [Canadian GMP Guidelines 2009]
Export Procedure
Allow Community goods to leave the customs territory of the Union. For the purpose of these guidelines, the supply of medicines from EU Member State to a contracting State of the European Economic Area is not considered as export. [EU GDP Guidelines]
Expression Construct
The expression vector which contains the coding sequence of the recombinant protein and the elements necessary for its expression. [ICH Q5B]
Extemporaneous Preparation
A product, which is dispensed immediately after preparation and not kept in stock. [PIC/S PE 010-4]
Extended Release
Products which are formulated to make the drug available over an extended period after administration. [ICH Q6A]
Extraneous Contaminant
An impurity arising from any source extraneous to the manufacturing process. [ICH Q3A]