B
Barrier
A physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Batch / Lot
A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous. Note: To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. For control of the finished product, the following definition has been given in Annex 1 of Directive 2001/83/EC as amended by Directive 2003/63/EC: 'For the control of the finished product, a batch of a proprietary medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time'. [EU GMP Guide, Glossary]
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. [EU GMP Guide, Part II, ICH Q7]
A defined quantity of pharmaceutical products processed in a single process or series of processes so that it is expected to be homogeneous. [Good Distribution Practices for Pharmaceutical Products, WHO, PIC/S PE 010-4]
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. [21 CFR Part 210, FDA, Guidance for Industry cGMP for Phase 1 Investigational Drugs, FDA]
One or more components or finished [medical] devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. [21 CFR Part 820, FDA]
A quantity of drug in dosage form, a raw material, or a packaging material, homogeneous within specified limits, produced according to a single production order and as attested by the signatories to the order. In the case of continuous manufacture, a batch corresponds to a defined fraction of the production, that is characterized by its intended homogeneity. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. [Canadian GMP Guidelines 2009]
Batch Certificate
A certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator
Batch Number / Lot Number / Control Number
A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined. [EU GMP Guide, Part II, ICH Q7]
A distinctive combination of numbers and/or letters that specifically identifies a batch. The batch number appears on the batch records, certificates of analysis, etc. [PIC/S PE 010-4, Canadian GMP Guidelines 2009]
A distinctive combination of numbers and/or letters which uniquely identifes a batch, for example, on the labels, its batch records and corresponding certificates of analysis. [Good Distribution Practices for Pharmaceutical Products, WHO]
Any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. [21 CFR Part 210, FDA]
Any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished [medical] devices can be determined. [21 CFR Part 820, FDA]
Batch Record
All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product. [Main Principles for Pharmaceutical Products, WHO]
Bespoke
A system produced for a customer, specifically to order, to meet a defined set of user requirements. [PIC/S PI 011-3]
Bioburden
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected. [EU GMP Guide Part II, ICH Q7]
The level and type (i.e. objectionable or not) of micro-organism present in raw materials, media, biological substances, intermediates or products. Regarded as contamination when the level and/or type exceed specifications. [EU GMP Guide, Annex 2]
Total number of viable microorganisms on or in a pharmaceutical product prior to sterilisation. [PIC/S PI 007-6]
The total number of microorganisms associated with a specific item prior to sterilization. [Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Biogenerator
A contained system, such as a fermenter, into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Biogenerators are generally fitted with devices for regulation, control, connection, material addition and material withdrawal. [EU GMP Guide, Glossary]
Biological Activity
The specific ability or capacity of the product to achieve a defined biological effect. Potency is the quantitative measure of the biological activity. [ICH Q6B]
Biological Agent
Microorganisms, including genetically engineered microorganisms, cell cultures and endoparasites, whether pathogenic or not. [EU GMP Guide, Glossary]
Biological Indicator (BI)
A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Biometrics
A method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. [21 CFR Part 11, FDA]
Biosafety Level (BSL)
The containment conditions required to safely handle organisms of different hazards ranging from BSL1 (lowest risk, unlikely to cause human disease) to BSL4 (highest risk, cause severe disease, likely to spread and no effective prophylaxis or treatment available). [EU GMP Guide, Annex 2]
Blending
Blending is the process of combining materials or different batches to produce a homogeneous intermediate or finished product. [Specific Pharmaceutical Products, WHO]
Blinding
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). In relation to an investigational medicinal product, blinding shall mean the deliberate disguising of the identity of the product in accordance with the instructions of the sponsor. Unblinding shall mean the disclosure of the identity of blinded products. [EU GMP Guide, Annex 13, Canadian GMP Guidelines 2009, Annex 13]
The lowest amount of analyte in a sample which can be quantitatively determined with defined precision and accuracy under the stated experimental conditions. [PIC/S PI 006-3]
Blood
Whole blood collected from a single donor and processed either for transfusion or further manufacturing. [EU GMP Guide, Annex 14]
Whole blood collected from a single donor and processed either for transfusion or further manufacturing. The term is often used to describe blood components in general. [Canadian GMP Guidelines 2009, Annex 14]
Blood Component
A therapeutic constituent of blood (red cells, white cells, platelets and plasma) that can be prepared by various methods. [EU GMP Guide, Annex 14]
A therapeutic agent produced by physical or mechanical separation of the constituents of whole blood. Components include, but are not limited to, red blood cells, platelets, plasma and cryoprecipitated Anti-Haemophiliac Factor (AHF). [Canadian GMP Guidelines 2009, Annex 14]
Blow / Fill / Seal Unit
Purpose built machines in which, in one continuous operation, containers are formed from a thermoplastic granulate, filled and then sealed, all by the one automatic machine. [Chinese GMP Guide, Annex1]
Bracketing
The design of a stability schedule such that only samples on the extremes of certain design factors (e.g., strength, package size) are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different sized capsule shells). Bracketing can be applied to different container sizes or to different fills in the same container closure system. [ICH Q1A, Canadian GMP Guidelines 2009]
Bracketing Approach
A validation scheme/protocol designed such that only batches on the extremes of certain predetermined and justified design factors, e.g., strength, batch size, pack size are tested during process validation. This approach assumes that validation of any intermediate levels is represented by the extremes validated. Where a range of strengths is to be validated, bracketing could be applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes or different fills in the same container closure system. [Guideline on Process Validation for Finished Products, EMA]
Brokering of Medicinal Products
All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. [Directive 2001/83/EC]
Bug
A manifestation of an error in software (a fault). [PIC/S PI 011-3]
Bulk Drug
(drogue en vrac) A drug in dosage form that is not in its final packaging, usually in quantities larger than the largest commercially available package size. [Canadian GMP Guidelines 2009]
Bulk Product
Any product that has completed all processing stages up to, but not including, final packaging. [EU GMP Guide, Glossary, PIC/S PE 010-4]
Bulk Production Batch
A batch of product, of a size described in the application for a marketing authorisation, either ready for assembly into final containers or in individual containers ready for assembly to final packs. (A bulk production batch may, for example, consist of a bulk quantity of liquid product, of solid dosage forms such as tablets or capsules, or of filled ampoules). [EU GMP Guide, Annex 16]
A physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Batch / Lot
A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous. Note: To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. For control of the finished product, the following definition has been given in Annex 1 of Directive 2001/83/EC as amended by Directive 2003/63/EC: 'For the control of the finished product, a batch of a proprietary medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time'. [EU GMP Guide, Glossary]
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. [EU GMP Guide, Part II, ICH Q7]
A defined quantity of pharmaceutical products processed in a single process or series of processes so that it is expected to be homogeneous. [Good Distribution Practices for Pharmaceutical Products, WHO, PIC/S PE 010-4]
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. [21 CFR Part 210, FDA, Guidance for Industry cGMP for Phase 1 Investigational Drugs, FDA]
One or more components or finished [medical] devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. [21 CFR Part 820, FDA]
A quantity of drug in dosage form, a raw material, or a packaging material, homogeneous within specified limits, produced according to a single production order and as attested by the signatories to the order. In the case of continuous manufacture, a batch corresponds to a defined fraction of the production, that is characterized by its intended homogeneity. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. [Canadian GMP Guidelines 2009]
Batch Certificate
A certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator
- identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document,
- provides a detailed description of the drug, including
- a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and
- a statement of tolerances for the properties and qualities of the drug,
- identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained,
- sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested, and
- certifies that the lot or batch was fabricated, packaged/labelled and tested in accordance with the Good Mufacturing Practices of the regulatory authority that has recognized those buildings as meeting its Good Mufacturing Practices standard.” (C.01A.001) (The certificate’s content is also described in Appendix A).
Batch Number / Lot Number / Control Number
A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined. [EU GMP Guide, Part II, ICH Q7]
A distinctive combination of numbers and/or letters that specifically identifies a batch. The batch number appears on the batch records, certificates of analysis, etc. [PIC/S PE 010-4, Canadian GMP Guidelines 2009]
A distinctive combination of numbers and/or letters which uniquely identifes a batch, for example, on the labels, its batch records and corresponding certificates of analysis. [Good Distribution Practices for Pharmaceutical Products, WHO]
Any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. [21 CFR Part 210, FDA]
Any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished [medical] devices can be determined. [21 CFR Part 820, FDA]
Batch Record
All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product. [Main Principles for Pharmaceutical Products, WHO]
Bespoke
A system produced for a customer, specifically to order, to meet a defined set of user requirements. [PIC/S PI 011-3]
Bioburden
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected. [EU GMP Guide Part II, ICH Q7]
The level and type (i.e. objectionable or not) of micro-organism present in raw materials, media, biological substances, intermediates or products. Regarded as contamination when the level and/or type exceed specifications. [EU GMP Guide, Annex 2]
Total number of viable microorganisms on or in a pharmaceutical product prior to sterilisation. [PIC/S PI 007-6]
The total number of microorganisms associated with a specific item prior to sterilization. [Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Biogenerator
A contained system, such as a fermenter, into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Biogenerators are generally fitted with devices for regulation, control, connection, material addition and material withdrawal. [EU GMP Guide, Glossary]
Biological Activity
The specific ability or capacity of the product to achieve a defined biological effect. Potency is the quantitative measure of the biological activity. [ICH Q6B]
Biological Agent
Microorganisms, including genetically engineered microorganisms, cell cultures and endoparasites, whether pathogenic or not. [EU GMP Guide, Glossary]
Biological Indicator (BI)
A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Biometrics
A method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. [21 CFR Part 11, FDA]
Biosafety Level (BSL)
The containment conditions required to safely handle organisms of different hazards ranging from BSL1 (lowest risk, unlikely to cause human disease) to BSL4 (highest risk, cause severe disease, likely to spread and no effective prophylaxis or treatment available). [EU GMP Guide, Annex 2]
Blending
Blending is the process of combining materials or different batches to produce a homogeneous intermediate or finished product. [Specific Pharmaceutical Products, WHO]
Blinding
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). In relation to an investigational medicinal product, blinding shall mean the deliberate disguising of the identity of the product in accordance with the instructions of the sponsor. Unblinding shall mean the disclosure of the identity of blinded products. [EU GMP Guide, Annex 13, Canadian GMP Guidelines 2009, Annex 13]
The lowest amount of analyte in a sample which can be quantitatively determined with defined precision and accuracy under the stated experimental conditions. [PIC/S PI 006-3]
Blood
Whole blood collected from a single donor and processed either for transfusion or further manufacturing. [EU GMP Guide, Annex 14]
Whole blood collected from a single donor and processed either for transfusion or further manufacturing. The term is often used to describe blood components in general. [Canadian GMP Guidelines 2009, Annex 14]
Blood Component
A therapeutic constituent of blood (red cells, white cells, platelets and plasma) that can be prepared by various methods. [EU GMP Guide, Annex 14]
A therapeutic agent produced by physical or mechanical separation of the constituents of whole blood. Components include, but are not limited to, red blood cells, platelets, plasma and cryoprecipitated Anti-Haemophiliac Factor (AHF). [Canadian GMP Guidelines 2009, Annex 14]
Blow / Fill / Seal Unit
Purpose built machines in which, in one continuous operation, containers are formed from a thermoplastic granulate, filled and then sealed, all by the one automatic machine. [Chinese GMP Guide, Annex1]
Bracketing
The design of a stability schedule such that only samples on the extremes of certain design factors (e.g., strength, package size) are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different sized capsule shells). Bracketing can be applied to different container sizes or to different fills in the same container closure system. [ICH Q1A, Canadian GMP Guidelines 2009]
Bracketing Approach
A validation scheme/protocol designed such that only batches on the extremes of certain predetermined and justified design factors, e.g., strength, batch size, pack size are tested during process validation. This approach assumes that validation of any intermediate levels is represented by the extremes validated. Where a range of strengths is to be validated, bracketing could be applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes or different fills in the same container closure system. [Guideline on Process Validation for Finished Products, EMA]
Brokering of Medicinal Products
All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. [Directive 2001/83/EC]
Bug
A manifestation of an error in software (a fault). [PIC/S PI 011-3]
Bulk Drug
(drogue en vrac) A drug in dosage form that is not in its final packaging, usually in quantities larger than the largest commercially available package size. [Canadian GMP Guidelines 2009]
Bulk Product
Any product that has completed all processing stages up to, but not including, final packaging. [EU GMP Guide, Glossary, PIC/S PE 010-4]
Bulk Production Batch
A batch of product, of a size described in the application for a marketing authorisation, either ready for assembly into final containers or in individual containers ready for assembly to final packs. (A bulk production batch may, for example, consist of a bulk quantity of liquid product, of solid dosage forms such as tablets or capsules, or of filled ampoules). [EU GMP Guide, Annex 16]