W
Water for Injection (WFI)
Aqua ad iniectabilia, ultra pure water, distilled water. [Pharmacopoea Europaea]
Wholesale
To sell drugs, other than at retail sale, where the seller's name does not appear on the label of the drugs. [Canadian GMP Guidelines 2009]
Wholesale Distribution of a Medicinal Product
All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned. [Directive 2001/83/EC]
Working Cell Bank (WCB)
A culture of cells derived from the master cell bank and intended for use in the preparation of production cell cultures. The working cell bank is usually stored at -70°C or lower. [EU GMP Guide, Glossary]
A homogeneous pool of micro-organisms or cells, that are distributed uniformly into a number of containers derived from a MCB that are stored in such a way to ensure stability and for use in production. Working virus seed (WVS) – as above but in relation to viruses, working transgenic bank – as above but for transgenic plants or animals. Zoonosis: Animal diseases that can be transmitted to humans. [EU GMP Guide, Annex 2]
The WCB is prepared from aliquots of a homogeneous suspension of cells obtained from culturing the MCB under defined culture conditions. [ICH Q5A, Q5B, Q5D]
Cell bank prepared from aliquots of a homogenous suspension of cells obtained from culturing the fully characterized MB under defined culture conditions. [Canadian GMP Guidelines 2009, Annex 2]
Working Session
A defined period where available evidence indicates that the appropriate working conditions are maintained. [PIC/S PE 010-4]
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. [Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Worst CaseA condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure. [EU GMP Guide, Annex 15, Main Principles for Pharmaceutical Products, WHO, PIC/S PI 006-3]
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. [Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aqua ad iniectabilia, ultra pure water, distilled water. [Pharmacopoea Europaea]
Wholesale
To sell drugs, other than at retail sale, where the seller's name does not appear on the label of the drugs. [Canadian GMP Guidelines 2009]
Wholesale Distribution of a Medicinal Product
All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned. [Directive 2001/83/EC]
Working Cell Bank (WCB)
A culture of cells derived from the master cell bank and intended for use in the preparation of production cell cultures. The working cell bank is usually stored at -70°C or lower. [EU GMP Guide, Glossary]
A homogeneous pool of micro-organisms or cells, that are distributed uniformly into a number of containers derived from a MCB that are stored in such a way to ensure stability and for use in production. Working virus seed (WVS) – as above but in relation to viruses, working transgenic bank – as above but for transgenic plants or animals. Zoonosis: Animal diseases that can be transmitted to humans. [EU GMP Guide, Annex 2]
The WCB is prepared from aliquots of a homogeneous suspension of cells obtained from culturing the MCB under defined culture conditions. [ICH Q5A, Q5B, Q5D]
Cell bank prepared from aliquots of a homogenous suspension of cells obtained from culturing the fully characterized MB under defined culture conditions. [Canadian GMP Guidelines 2009, Annex 2]
Working Session
A defined period where available evidence indicates that the appropriate working conditions are maintained. [PIC/S PE 010-4]
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. [Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Worst CaseA condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure. [EU GMP Guide, Annex 15, Main Principles for Pharmaceutical Products, WHO, PIC/S PI 006-3]
A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. [Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Y
Yield, Actual
The quantity that is actually produced at any appropriate phase of manufacture, processing, or packaging of a particular drug product. [21 CFR Part 210, FDA]
Yield, Expected
The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale, or manufacturing data. [EU GMP Guide, Part II, ICH Q7]
Yield, Theoretical
The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production. [EU GMP Guide, Part II, ICH Q7]
The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production. [21 CFR Part 210, FDA]
The quantity that is actually produced at any appropriate phase of manufacture, processing, or packaging of a particular drug product. [21 CFR Part 210, FDA]
Yield, Expected
The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale, or manufacturing data. [EU GMP Guide, Part II, ICH Q7]
Yield, Theoretical
The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production. [EU GMP Guide, Part II, ICH Q7]
The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production. [21 CFR Part 210, FDA]
Z
Zoonosis
Animal diseases that can be transmitted to humans. [EU GMP Guide, Annex 2]
Animal diseases that can be transmitted to humans. [EU GMP Guide, Annex 2]