F
Facility
Any area, including mobile clinic sites, used for the collection, testing, component production, storage (including records) or distribution of blood and blood components. [Canadian GMP Guidelines, Annex 14]
Factory Acceptance Test (FAT)
The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricators site (ISPE).
Failure Mode and Effects Analysis (FMEA)
Provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and / or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. [ICH Q9]
Failure Mode, Effects and Criticality Analysis (FMECA)
A systematic method of identifying and preventing product and process problems. [TRS 981 Annex 2, WHO]
Falsified Medicinal Product
Any medicinal product with a false representation of:
Feedback/Feedforward
Feedback: The modification or control of a process or system by its results or effects.
Feedforward: The modification or control of a process using its anticipated results or effects. (Oxford Dictionary of English. Oxford University Press, 2003)
Feedback/ feedforward can be applied technically in process control strategies and conceptually in quality management. [ICH Q10]
Feeder Cells
Cells used in co-culture to maintain pluripotent stem cells. For human embryonic stem cell culture, typical feeder layers include mouse embryonic fibroblasts (MEFs) or human embryonic fibroblasts that have been treated to prevent them from dividing. [EU GMP Guide, Annex 2]
Fermentation
A process in which cells or microorganisms are cultured in a container (bioreactor or fermenter), in liquid or solid medium, for experimental or commercial processes. [Canadian GMP Guidelines, Annex 2]
Fiber
Any particulate contaminant with a length at least three times greater than its width. [21 CFR Part 210, FDA]
Filling
(remplissage) Transferring a bulk drug into its final container and enclosing it in the container. [Canadian GMP Guidelines 2009]
Finished Device
Any [medical] device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. [21 CFR Part 820, FDA]
Finished Product
A medicinal product which has undergone all stages of production, including packaging in its final container. [EU GMP Guide, Part I, Glossary, PIC/S PE 010-4]
A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling. [TRS 908 Annex 4, WHO]
(produit fini) A product that has undergone all stages of production, including packaging in its final container and labelling. [Canadian GMP Guidelines 2009]
Finished Product Batch
With reference to the control of the finished product, a finished product batch is defined in Part 1 Module 3 point 3.2.2.5 of Directive 2001/83/EC2 and in Part 2 section F 1 of Directive 2001/82/EC. In the context of this annex the term in particular denotes the batch of product in its final pack for release to the market. [EU GMP Guide, Annex 16]
Firmware
A software program permanently recorded in a hardware device, such as an EPROM. (Note: EPROM stands for ‘Erasable Programmable Read Only Memory’). [PIC/S PI 011-3]
First Expiry, First Out (FEFO)
A distribution procedure that ensures that the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used. [Good Distribution Practices for Pharmaceutical Pro-ducts, WHO]
Flanking Control Region
Non-coding nucleotide sequences that are adjacent to the 5' and 3' end of the coding sequence of the product which contain important elements that affect the transcription, translation, or stability of the coding sequence. These regions include, e.g., promoter, enhancer, and splicing sequences and do not include origins of replication and antibiotic resistance genes. [ICH Q5B]
FMEA
see Failure Mode and Effects Analysis
FMECA
see Failure Mode, Effects and Criticality Analysis
Forced Degradation Testing Study
Studies undertaken to degrade the sample deliberately. These studies, which may be undertaken in the development phase normally on the drug substances, are used to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation. [ICH Q1B]
Formal Experimental Design
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. Also known as “Design of Experiments”. [ICH Q8]
Formal Stability Study
Long term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the re-test period of a drug substance or the shelf life of a drug product. [ICH Q1A]
Formulating
(transformation) Preparing components and combining raw materials into a bulk drug. [Canadian GMP Guidelines 2009]
Free Zone and Free Warehouse
Parts of the customs territory of the Community or premises situated in that territory and separated from the rest of it which:
Functional Requirement
Statements that describe functions a computer-related system must be capable of performing. [PIC/S PI 011-3]
Functional Specification
Statements of how the computerised system will satisfy functional requirements of the computer-related system. [PIC/S PI 011-3]
Functional Testing
A process for verifying that software, a system, or a system component performs its intended functions. [PIC/S PI 011-3]
Any area, including mobile clinic sites, used for the collection, testing, component production, storage (including records) or distribution of blood and blood components. [Canadian GMP Guidelines, Annex 14]
Factory Acceptance Test (FAT)
The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricators site (ISPE).
Failure Mode and Effects Analysis (FMEA)
Provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and / or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. [ICH Q9]
Failure Mode, Effects and Criticality Analysis (FMECA)
A systematic method of identifying and preventing product and process problems. [TRS 981 Annex 2, WHO]
Falsified Medicinal Product
Any medicinal product with a false representation of:
- Its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients,
- its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder, or
- its history, including the records and documents relating to the distribution channels used. [EU GDP Guidelines, Directive 2001/83/EC]
Feedback/Feedforward
Feedback: The modification or control of a process or system by its results or effects.
Feedforward: The modification or control of a process using its anticipated results or effects. (Oxford Dictionary of English. Oxford University Press, 2003)
Feedback/ feedforward can be applied technically in process control strategies and conceptually in quality management. [ICH Q10]
Feeder Cells
Cells used in co-culture to maintain pluripotent stem cells. For human embryonic stem cell culture, typical feeder layers include mouse embryonic fibroblasts (MEFs) or human embryonic fibroblasts that have been treated to prevent them from dividing. [EU GMP Guide, Annex 2]
Fermentation
A process in which cells or microorganisms are cultured in a container (bioreactor or fermenter), in liquid or solid medium, for experimental or commercial processes. [Canadian GMP Guidelines, Annex 2]
Fiber
Any particulate contaminant with a length at least three times greater than its width. [21 CFR Part 210, FDA]
Filling
(remplissage) Transferring a bulk drug into its final container and enclosing it in the container. [Canadian GMP Guidelines 2009]
Finished Device
Any [medical] device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. [21 CFR Part 820, FDA]
Finished Product
A medicinal product which has undergone all stages of production, including packaging in its final container. [EU GMP Guide, Part I, Glossary, PIC/S PE 010-4]
A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling. [TRS 908 Annex 4, WHO]
(produit fini) A product that has undergone all stages of production, including packaging in its final container and labelling. [Canadian GMP Guidelines 2009]
Finished Product Batch
With reference to the control of the finished product, a finished product batch is defined in Part 1 Module 3 point 3.2.2.5 of Directive 2001/83/EC2 and in Part 2 section F 1 of Directive 2001/82/EC. In the context of this annex the term in particular denotes the batch of product in its final pack for release to the market. [EU GMP Guide, Annex 16]
Firmware
A software program permanently recorded in a hardware device, such as an EPROM. (Note: EPROM stands for ‘Erasable Programmable Read Only Memory’). [PIC/S PI 011-3]
First Expiry, First Out (FEFO)
A distribution procedure that ensures that the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used. [Good Distribution Practices for Pharmaceutical Pro-ducts, WHO]
Flanking Control Region
Non-coding nucleotide sequences that are adjacent to the 5' and 3' end of the coding sequence of the product which contain important elements that affect the transcription, translation, or stability of the coding sequence. These regions include, e.g., promoter, enhancer, and splicing sequences and do not include origins of replication and antibiotic resistance genes. [ICH Q5B]
FMEA
see Failure Mode and Effects Analysis
FMECA
see Failure Mode, Effects and Criticality Analysis
Forced Degradation Testing Study
Studies undertaken to degrade the sample deliberately. These studies, which may be undertaken in the development phase normally on the drug substances, are used to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation. [ICH Q1B]
Formal Experimental Design
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. Also known as “Design of Experiments”. [ICH Q8]
Formal Stability Study
Long term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the re-test period of a drug substance or the shelf life of a drug product. [ICH Q1A]
Formulating
(transformation) Preparing components and combining raw materials into a bulk drug. [Canadian GMP Guidelines 2009]
Free Zone and Free Warehouse
Parts of the customs territory of the Community or premises situated in that territory and separated from the rest of it which:
- Community goods are considered, for the purpose of import duties and commercial policy import measures, as not being on Community customs territory, provided they are not released for free circulation or placed under another customs procedure or used or consumed under conditions other than those provided for in customs regulations,
- Community goods for which such provision is made under Community legislation governing specific fields qualify, by virtue of being placed in a free zone or free warehouse, for measures normally attaching to the export of goods. [EU GDP Guidelines]
Functional Requirement
Statements that describe functions a computer-related system must be capable of performing. [PIC/S PI 011-3]
Functional Specification
Statements of how the computerised system will satisfy functional requirements of the computer-related system. [PIC/S PI 011-3]
Functional Testing
A process for verifying that software, a system, or a system component performs its intended functions. [PIC/S PI 011-3]