A
Abuse of Medicinal Products
Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects. [Directive 2001/83/EC]
Accelerated Testing
Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long term stability studies, can be used to assess longer term chemical effects at non accelerated conditions and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes. [ICH Q1A]
Accelerator
A device to accelerate energetic charged particles linearly or in circular paths by means of a radiofrequency field and an electromagnetic field in case of cyclotrons. The accelerated particles cause nuclear reactions in the atoms of targets placed in their path. [Canadian GMP Guidelines 2009, Annex 5]
Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of test results. [EU GMP Guide, Part II]
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures. [ICH Q6A]
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet. [ICH Q6B]
Measurable terms under which a test result will be considered acceptable. [Main Principles for Pharmaceutical Products, WHO]
The criteria assigned, before undertaking testing, to allow evaluation of test results to demonstrate compliance with a test phase of delivery requirement (Pre-Determined Acceptance Criteria). [PIC/S PI 006-3]
Product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). [21 CFR Part 210, FDA]
Numerical limits, ranges, or other suitable measures of test results necessary to determine acceptance of the drug substance, drug products, or materials at stages of their manufacture. [Guidance for Industry cGMP for Phase 1 Investigational Drugs, FDA]
Accuracy
The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness. [ICH Q2]
Action Level / Action Limit
An internal (in-house) value used to assess the consistency of the process at less critical steps. [ICH Q6B]
Established criteria, e.g. microbial or particulate levels, requiring immediate follow-up and corrective action if exceeded. [PIC/S PI 007-6]
The action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results outside these limits will require specified action and investigation. [Main Principles for Pharmaceutical Products, WHO]
An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Active Pharmaceutical Ingredient (API) / Drug Substance
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. [EU GMP Guide Part II, FDA Guidance for Industry cGMP for Phase 1 Investigational Drugs, ICH Q7, Canadian GMP Guidelines 2009]
The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form. [ICH Q1A]
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
Any substance or mixture of substances to which the effect of a finished medicinal product is adjudged, or which acts as such. [PIC/S PE 010-4]
Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. [21 CFR Part 210, FDA]
Active Substance
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis. [Directive 2001/83/EC]
Active Substance Gas
Any gas intended to be an active substance for a medicinal product. [EU GMP Guide, Annex 6]
Adjuvant
A chemical or biological substance that enhances the immune response against an antigen. [EU GMP Guide, Annex 2]
Advanced Electronic Signature
(see also Electronic Signature)
An electronic signature, which meets the following requirements:
(a) it is uniquely linked to the signatory,
(b) it is capable of identifying the signatory,
(c) it is created using means that the signatory can maintain under his control, and
(d) it is linked to the data to which it relates in such a manner that any change of the data is detectable.
[PIC/S PI 011-3]
Adventitious Virus
Unintentionally introduced contaminant virus. [ICH Q5A, Canadian GMP Guidelines 2009, Annex 2]
Adverse Event
(see also Serious Adverse Event)
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. [Directive 2001/20/EC]
Adverse Reaction
(see also Serious Adverse Reaction (SAR))
A response to a medicinal product which is noxious and unintended. [Directive 2001/83/EC]
Agitated Immersion
A system of cleaning in which the manufacturing equipment is filled with cleaning solution, and the cleaning solution is agitated, usually with the existing agitation equipment in that equipment.
Agitation
The mixing or movement of a cleaning solution in the equipment. Agitation may occur from flow of the cleaning solution, or it may be due to mixers or impellers. Agitation continually supplies fresh cleaning solution to the surfaces.
Air Lock
An enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling the air-flow between those rooms when they need to be entered. An air-lock is designed for and used by either people or goods. [EU GMP Guide, Glossary]
A small room with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic processing air lock is to preclude ingress of particulate matter and microorganism contamination from a lesser controlled area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
An enclosed space with two or more doors, that is interposed between two or more rooms, usually of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when either people or goods need to enter or leave them. [Canadian GMP Guidelines 2009]
Air Separation
Separation of atmospheric air into its constituent gases using fractional distillation at cryogenic temperatures. [EU GMP Guide, Annex 6]
Air Separation Plant
Air separation plants take atmospheric air and through processes of purification, cleaning, compression, cooling, liquefaction and distillation separate the air into the gases oxygen, nitrogen and argon. [EU GMP Guide, Annex 6]
Alert Level
An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Alert Limit
The alert limit is reached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached. [Main Principles for Pharmaceutical Products, WHO]
(media fill) Established levels or numbers of positive media filled units, the cause of which should be investigated, but which are not necessarily grounds for definitive corrective action. [PIC/S PI 007-6]
(environmental monitoring) Established microbial or particulate levels giving early warning of potential drift from normal operating conditions which are not necessarily grounds for definitive corrective action but which require follow-up investigation. [PIC/S PI 007-6]
Allergoid
Allergens which are chemically modified to reduce IgE reactivity. [EU GMP Guide, Annex 2]
Allogeneic Donation
Blood collected from an individual and placed in the general blood supply for the purpose of transfusion to another person. [Canadian GMP Guidelines, Annex 14]
Analytical Procedure
The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. [ICH Q2]
Annual Review
An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
AntibodyProteins produced by the B-lymphocytes that bind to specific antigens. Antibodies may divided into 2 main types based on key differences in their method of manufacture. [EU GMP Guide, Annex 2]
Antibody Screen
Serological test by which donor serum/plasma is tested with reagent red cells of known antigenic profile to determine if unexpected clinically significant antibodies are present. "clinically significant" refers to antibodies that may cause adverse reactions in the recipient due to incompatibility. [Canadian GMP Guidelines, Annex 14]
Antibody, monoclonal (MAb)
Homogenous antibody population obtained from a single clone of lymphocytes or by recombinant technology and which bind to a single epitope. [EU GMP Guide, Annex 2]
Antibody, polyclonal
Derived from a range of lymphocyte clones, produced in human and animals in response to the epitopes on most 'non-self' molecules. [EU GMP Guide, Annex 2]
Antigen
Substances (e.g. toxins, foreign proteins, bacteria, tissue cells) capable of inducing specific immune responses. [EU GMP Guide, Annex 2]
API
see Active Pharmaceutical Ingredient
API Starting Material
A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure. [EU GMP Guide, Part II, ICH Q7]
Application-Specific Software
A software program developed or adapted to the specific requirements of the application. [PIC/S PI 011-3]
Area
A specific set of rooms within a building associated with the manufacturing of any one product or multiple products that has a common air handling unit. [EU GMP Guide, Annex 2]
Asepsis
A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Area
A zone or zones within a clean area where Grade A or B conditions are maintained (see table in Section C.02.029 of these guidelines). [Canadian GMP Guidelines 2009]
The place, among the work areas, where the aseptic drug substances or sterilised containers are exposed to the air in the work areas, where the filling operations for the drug substances are conducted, where the sealing operations for the containers are conducted, or where the aseptic operations including sterility tests are conducted. [Japan MHLW Ministerial Ordinance No. 179, 2004]
Aseptic Filling
Operation whereby the product is sterilised separately, then filled and packaged using sterilised containers and closures in critical processing zones. [PIC/S PI 007-6]
Aseptic Manufacturing Area
The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms. For purposes of this document, this term is synonymous with “aseptic processing facility” as used in the segregated segment context. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Process
A method of producing a sterile product in which sterile bulk drug or sterile raw materials are compounded and assembled with sterile packaging components under Grade A or B conditions (see table in Section C.02.029 of these guidelines). [Canadian GMP Guidelines 2009]
Aseptic Processing Facility
A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Processing Room
A room in which one or more aseptic activities or processes is performed. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Technique and Manipulation
The manipulation of sterile materials in such a way as to minimize the risk of microbiological contamination from the environment. These techniques usually involve eliminating surface to surface contacts (except between sterile surfaces) minimizing the area exposed and the duration of exposure. [PIC/S PI 014-3]
At-Line
Measurement where the sample is removed, isolated from, and analysed in close proximity to the process stream. [Guideline on process validation for finished products, EMA]
At-Rest
Condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present. [Main Principles for Pharmaceutical Products, WHO]
Condition where the installation is installed, complete with production equipment but with no operating personnel present and no production activities. [Chinese GMP Guidelines, Annex1]
Auditing / Inspection
One-site assessment of the compliance with the Community GMP principles performed by officials of Community Competent Authorities. [Compilation of Community Procedures on Inspections and Exchange of Information, EMA]
An independent and objective activity designed to add value and improve an organization’s operations by helping the organization to accomplish its objectives by using a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes. [Good Distribution Practices for Pharmaceutical Products, WHO]
Autologous Donation
Blood collected from an individual for the purpose of transfusion back to the same individual. [Canadian GMP Guidelines, Annex 14]
Automated System
Term used to cover a broad range of systems, including automated manufacturing equipment, control systems, automated laboratory systems manufacturing execution systems and computers running laboratory or manufacturing database systems. The automated system consists of the hardware, software and network components, together with the controlled functions and associated documentation. Automated systems are sometimes referred to as computerised systems, in this Guide the two terms are synonymous. [PIC/S PI 011-3]
Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects. [Directive 2001/83/EC]
Accelerated Testing
Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long term stability studies, can be used to assess longer term chemical effects at non accelerated conditions and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes. [ICH Q1A]
Accelerator
A device to accelerate energetic charged particles linearly or in circular paths by means of a radiofrequency field and an electromagnetic field in case of cyclotrons. The accelerated particles cause nuclear reactions in the atoms of targets placed in their path. [Canadian GMP Guidelines 2009, Annex 5]
Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of test results. [EU GMP Guide, Part II]
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures. [ICH Q6A]
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet. [ICH Q6B]
Measurable terms under which a test result will be considered acceptable. [Main Principles for Pharmaceutical Products, WHO]
The criteria assigned, before undertaking testing, to allow evaluation of test results to demonstrate compliance with a test phase of delivery requirement (Pre-Determined Acceptance Criteria). [PIC/S PI 006-3]
Product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). [21 CFR Part 210, FDA]
Numerical limits, ranges, or other suitable measures of test results necessary to determine acceptance of the drug substance, drug products, or materials at stages of their manufacture. [Guidance for Industry cGMP for Phase 1 Investigational Drugs, FDA]
Accuracy
The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness. [ICH Q2]
Action Level / Action Limit
An internal (in-house) value used to assess the consistency of the process at less critical steps. [ICH Q6B]
Established criteria, e.g. microbial or particulate levels, requiring immediate follow-up and corrective action if exceeded. [PIC/S PI 007-6]
The action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results outside these limits will require specified action and investigation. [Main Principles for Pharmaceutical Products, WHO]
An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Active Pharmaceutical Ingredient (API) / Drug Substance
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. [EU GMP Guide Part II, FDA Guidance for Industry cGMP for Phase 1 Investigational Drugs, ICH Q7, Canadian GMP Guidelines 2009]
The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form. [ICH Q1A]
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
Any substance or mixture of substances to which the effect of a finished medicinal product is adjudged, or which acts as such. [PIC/S PE 010-4]
Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. [21 CFR Part 210, FDA]
Active Substance
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis. [Directive 2001/83/EC]
Active Substance Gas
Any gas intended to be an active substance for a medicinal product. [EU GMP Guide, Annex 6]
Adjuvant
A chemical or biological substance that enhances the immune response against an antigen. [EU GMP Guide, Annex 2]
Advanced Electronic Signature
(see also Electronic Signature)
An electronic signature, which meets the following requirements:
(a) it is uniquely linked to the signatory,
(b) it is capable of identifying the signatory,
(c) it is created using means that the signatory can maintain under his control, and
(d) it is linked to the data to which it relates in such a manner that any change of the data is detectable.
[PIC/S PI 011-3]
Adventitious Virus
Unintentionally introduced contaminant virus. [ICH Q5A, Canadian GMP Guidelines 2009, Annex 2]
Adverse Event
(see also Serious Adverse Event)
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. [Directive 2001/20/EC]
Adverse Reaction
(see also Serious Adverse Reaction (SAR))
A response to a medicinal product which is noxious and unintended. [Directive 2001/83/EC]
Agitated Immersion
A system of cleaning in which the manufacturing equipment is filled with cleaning solution, and the cleaning solution is agitated, usually with the existing agitation equipment in that equipment.
Agitation
The mixing or movement of a cleaning solution in the equipment. Agitation may occur from flow of the cleaning solution, or it may be due to mixers or impellers. Agitation continually supplies fresh cleaning solution to the surfaces.
Air Lock
An enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling the air-flow between those rooms when they need to be entered. An air-lock is designed for and used by either people or goods. [EU GMP Guide, Glossary]
A small room with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic processing air lock is to preclude ingress of particulate matter and microorganism contamination from a lesser controlled area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
An enclosed space with two or more doors, that is interposed between two or more rooms, usually of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when either people or goods need to enter or leave them. [Canadian GMP Guidelines 2009]
Air Separation
Separation of atmospheric air into its constituent gases using fractional distillation at cryogenic temperatures. [EU GMP Guide, Annex 6]
Air Separation Plant
Air separation plants take atmospheric air and through processes of purification, cleaning, compression, cooling, liquefaction and distillation separate the air into the gases oxygen, nitrogen and argon. [EU GMP Guide, Annex 6]
Alert Level
An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Alert Limit
The alert limit is reached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached. [Main Principles for Pharmaceutical Products, WHO]
(media fill) Established levels or numbers of positive media filled units, the cause of which should be investigated, but which are not necessarily grounds for definitive corrective action. [PIC/S PI 007-6]
(environmental monitoring) Established microbial or particulate levels giving early warning of potential drift from normal operating conditions which are not necessarily grounds for definitive corrective action but which require follow-up investigation. [PIC/S PI 007-6]
Allergoid
Allergens which are chemically modified to reduce IgE reactivity. [EU GMP Guide, Annex 2]
Allogeneic Donation
Blood collected from an individual and placed in the general blood supply for the purpose of transfusion to another person. [Canadian GMP Guidelines, Annex 14]
Analytical Procedure
The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. [ICH Q2]
Annual Review
An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
AntibodyProteins produced by the B-lymphocytes that bind to specific antigens. Antibodies may divided into 2 main types based on key differences in their method of manufacture. [EU GMP Guide, Annex 2]
Antibody Screen
Serological test by which donor serum/plasma is tested with reagent red cells of known antigenic profile to determine if unexpected clinically significant antibodies are present. "clinically significant" refers to antibodies that may cause adverse reactions in the recipient due to incompatibility. [Canadian GMP Guidelines, Annex 14]
Antibody, monoclonal (MAb)
Homogenous antibody population obtained from a single clone of lymphocytes or by recombinant technology and which bind to a single epitope. [EU GMP Guide, Annex 2]
Antibody, polyclonal
Derived from a range of lymphocyte clones, produced in human and animals in response to the epitopes on most 'non-self' molecules. [EU GMP Guide, Annex 2]
Antigen
Substances (e.g. toxins, foreign proteins, bacteria, tissue cells) capable of inducing specific immune responses. [EU GMP Guide, Annex 2]
API
see Active Pharmaceutical Ingredient
API Starting Material
A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure. [EU GMP Guide, Part II, ICH Q7]
Application-Specific Software
A software program developed or adapted to the specific requirements of the application. [PIC/S PI 011-3]
Area
A specific set of rooms within a building associated with the manufacturing of any one product or multiple products that has a common air handling unit. [EU GMP Guide, Annex 2]
Asepsis
A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Area
A zone or zones within a clean area where Grade A or B conditions are maintained (see table in Section C.02.029 of these guidelines). [Canadian GMP Guidelines 2009]
The place, among the work areas, where the aseptic drug substances or sterilised containers are exposed to the air in the work areas, where the filling operations for the drug substances are conducted, where the sealing operations for the containers are conducted, or where the aseptic operations including sterility tests are conducted. [Japan MHLW Ministerial Ordinance No. 179, 2004]
Aseptic Filling
Operation whereby the product is sterilised separately, then filled and packaged using sterilised containers and closures in critical processing zones. [PIC/S PI 007-6]
Aseptic Manufacturing Area
The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms. For purposes of this document, this term is synonymous with “aseptic processing facility” as used in the segregated segment context. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Process
A method of producing a sterile product in which sterile bulk drug or sterile raw materials are compounded and assembled with sterile packaging components under Grade A or B conditions (see table in Section C.02.029 of these guidelines). [Canadian GMP Guidelines 2009]
Aseptic Processing Facility
A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Processing Room
A room in which one or more aseptic activities or processes is performed. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Aseptic Technique and Manipulation
The manipulation of sterile materials in such a way as to minimize the risk of microbiological contamination from the environment. These techniques usually involve eliminating surface to surface contacts (except between sterile surfaces) minimizing the area exposed and the duration of exposure. [PIC/S PI 014-3]
At-Line
Measurement where the sample is removed, isolated from, and analysed in close proximity to the process stream. [Guideline on process validation for finished products, EMA]
At-Rest
Condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present. [Main Principles for Pharmaceutical Products, WHO]
Condition where the installation is installed, complete with production equipment but with no operating personnel present and no production activities. [Chinese GMP Guidelines, Annex1]
Auditing / Inspection
One-site assessment of the compliance with the Community GMP principles performed by officials of Community Competent Authorities. [Compilation of Community Procedures on Inspections and Exchange of Information, EMA]
An independent and objective activity designed to add value and improve an organization’s operations by helping the organization to accomplish its objectives by using a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes. [Good Distribution Practices for Pharmaceutical Products, WHO]
Autologous Donation
Blood collected from an individual for the purpose of transfusion back to the same individual. [Canadian GMP Guidelines, Annex 14]
Automated System
Term used to cover a broad range of systems, including automated manufacturing equipment, control systems, automated laboratory systems manufacturing execution systems and computers running laboratory or manufacturing database systems. The automated system consists of the hardware, software and network components, together with the controlled functions and associated documentation. Automated systems are sometimes referred to as computerised systems, in this Guide the two terms are synonymous. [PIC/S PI 011-3]