V
Validation (see also Qualification, see also Verification)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria. [EU GMP Guide, Part II, ICH Q7]
Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results. [EU GMP Guide, Glossary, Main Principles for Pharmaceutical Products, WHO]
The risk based, systematic, GMP compliant and documented evidence that a defined process actually leads reproducibly to the required results. [PIC/S PE 010-4]
Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results. [TRS 961 Annex 7, WHO]
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, FDA]
Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor) [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. [21 CFR Part 820, FDA]
The documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Includes the qualification of systems and equipment. [Canadian GMP Guidelines 2009]
To verify and document that the buildings and facilities of the manufacturing site, procedures, processes and other procedures of the manufacturing control and quality control provide the anticipated results. [Japan MHLW Ministerial Ordinance No. 179, 2004]
Validation Master Plan (VMP)
The VMP is a high-level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s validation work programme and defines details of and timescales for the validation work to be performed, including a statement of the responsibilities of those implementing the plan. [TRS 961 Annex 7, WHO, Main Principles for Pharmaceutical Products, WHO]
A document providing information on the company’s validation work programme. It should define details of and timescales for the validation work to be performed. Responsibilities relating to the plan should be stated. [PIC/S PI 006-3]
Validation Protocol / Validation Plan (VP)
A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results. [EU GMP Guide, Part II, ICH Q7]
A document describing the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process – or a part thereof – for routine use. [Main Principles for Pharmaceutical Products, WHO]
A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results. [PIC/S PI 006-3]
Validation Report (VR)
A document in which the records, results and evaluation of a completed validation programme are assembled and summarized. It may also contain proposals for the improvement of processes and/or equipment. [Main Principles for Pharmaceutical Products, WHO]
Document reporting the validation activities, the validation data and the conclusions drawn. [PIC/S PI 006-3]
Valve
Device for opening and closing containers. [EU GMP Guide, Annex 6]
Vector
An agent of transmission, which transmits genetic information from one cell or organism to another, e.g. plasmids, liposomes, viruses. [EU GMP Guide, Annex 2]
Vegetable Drug
see Crude Plant
Vendor
Person who is the fabricator of the item (raw material, packaging material, medicinal ingredients, reagents). [Canadian GMP Guidelines 2009]
Vent
To remove the residual gas from a container/system down to 1,013 bar, by opening the container/system to atmosphere. [EU GMP Guide, Annex 6]
Vent Filter
Non-shedding porous material capable of removing viable and non-viable particles from gases passing in and out of a closed vessel. [PIC/S PI 007-6]
Verification(see also Validation)
The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the GMP principles/ quality risk management activities. [Main Principles for Pharmaceutical Products, WHO, TRS 981 Annex 2, WHO]
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. [21 CFR Part 820, FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Veterinary Drugs
Drugs that are administered to food-producing and companion animals. [Canadian GMP Guidelines 2009]
Viral Clearance
Elimination of target virus by removal of viral particles or inactivation of viral infectivity. [ICH Q5A]
Viral Vector
A vector derived from a virus and modified by means of molecular biology techniques in a way as to retain some, but not all, the parental virus genes, if the genes responsible for virus replication capacity are deleted, the vector is made replication-incompetent. [EU GMP Guide, Annex 2]
Virus
Intracellularly replicating infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA), are unable to grow and undergo binary fission, and multiply in the form of their genetic material. [ICH Q5A]
Virus Removal
Physical separation of virus particles from the intended product. [ICH Q5A]
Virus-like Particle
Structures visible by electron microscopy which morphologically appear to be related to known viruses. [ICH Q5A]
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria. [EU GMP Guide, Part II, ICH Q7]
Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results. [EU GMP Guide, Glossary, Main Principles for Pharmaceutical Products, WHO]
The risk based, systematic, GMP compliant and documented evidence that a defined process actually leads reproducibly to the required results. [PIC/S PE 010-4]
Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results. [TRS 961 Annex 7, WHO]
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, FDA]
Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor) [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. [21 CFR Part 820, FDA]
The documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Includes the qualification of systems and equipment. [Canadian GMP Guidelines 2009]
To verify and document that the buildings and facilities of the manufacturing site, procedures, processes and other procedures of the manufacturing control and quality control provide the anticipated results. [Japan MHLW Ministerial Ordinance No. 179, 2004]
Validation Master Plan (VMP)
The VMP is a high-level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s validation work programme and defines details of and timescales for the validation work to be performed, including a statement of the responsibilities of those implementing the plan. [TRS 961 Annex 7, WHO, Main Principles for Pharmaceutical Products, WHO]
A document providing information on the company’s validation work programme. It should define details of and timescales for the validation work to be performed. Responsibilities relating to the plan should be stated. [PIC/S PI 006-3]
Validation Protocol / Validation Plan (VP)
A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results. [EU GMP Guide, Part II, ICH Q7]
A document describing the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process – or a part thereof – for routine use. [Main Principles for Pharmaceutical Products, WHO]
A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results. [PIC/S PI 006-3]
Validation Report (VR)
A document in which the records, results and evaluation of a completed validation programme are assembled and summarized. It may also contain proposals for the improvement of processes and/or equipment. [Main Principles for Pharmaceutical Products, WHO]
Document reporting the validation activities, the validation data and the conclusions drawn. [PIC/S PI 006-3]
Valve
Device for opening and closing containers. [EU GMP Guide, Annex 6]
Vector
An agent of transmission, which transmits genetic information from one cell or organism to another, e.g. plasmids, liposomes, viruses. [EU GMP Guide, Annex 2]
Vegetable Drug
see Crude Plant
Vendor
Person who is the fabricator of the item (raw material, packaging material, medicinal ingredients, reagents). [Canadian GMP Guidelines 2009]
Vent
To remove the residual gas from a container/system down to 1,013 bar, by opening the container/system to atmosphere. [EU GMP Guide, Annex 6]
Vent Filter
Non-shedding porous material capable of removing viable and non-viable particles from gases passing in and out of a closed vessel. [PIC/S PI 007-6]
Verification(see also Validation)
The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the GMP principles/ quality risk management activities. [Main Principles for Pharmaceutical Products, WHO, TRS 981 Annex 2, WHO]
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. [21 CFR Part 820, FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Veterinary Drugs
Drugs that are administered to food-producing and companion animals. [Canadian GMP Guidelines 2009]
Viral Clearance
Elimination of target virus by removal of viral particles or inactivation of viral infectivity. [ICH Q5A]
Viral Vector
A vector derived from a virus and modified by means of molecular biology techniques in a way as to retain some, but not all, the parental virus genes, if the genes responsible for virus replication capacity are deleted, the vector is made replication-incompetent. [EU GMP Guide, Annex 2]
Virus
Intracellularly replicating infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA), are unable to grow and undergo binary fission, and multiply in the form of their genetic material. [ICH Q5A]
Virus Removal
Physical separation of virus particles from the intended product. [ICH Q5A]
Virus-like Particle
Structures visible by electron microscopy which morphologically appear to be related to known viruses. [ICH Q5A]