Q
Q4B Outcome
Produced by the Q4B evaluation process, information concerning how the evaluated pharmacopoeial text can be used. The Q4B Outcome is included as part of the topic-specific Q4B annex developed as a result of each favourable evaluation. [ICH Q4B]
QC Laboratory Inspection
On-Site assessment of the adherence to Good Quality Control Laboratory Practice is normally part of a GMP Inspection. Contract QC Laboratories authorised according to Article 13.1 of Directive 2001/20/EC are also subject to these inspections. Laboratory inspection for compliance with GLP Principles is performed in accordance with guidelines given in the annexes to Directive 90/18/EEC and is not part of this document. Inspections performed in laboratories analysing samples taken from trial subjects are likewise not included.
[Compilation of Community Procedures on Inspections and Exchange of Information, EMA]
Qualification(see also Validation)
Action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification. [EU GMP Guide, Glossary, EU GDP Guidelines, Main Principles for Pharmaceutical Products, WHO]
The process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the level(s) specified. [ICH Q3A, Q3B]
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. [ICH Q7]
The risk based systematic and documented evidence that facilities, rooms or equipment work correctly, are suitable for the intended purpose and actually give the expected results. [PIC/S PE 010-4]
Identification of equipment attributes related to the performance of a particular function or functions and allocation of certain limits or restrictions to those attributes. [PIC/S PI 006-3]
Qualification Batch
Those batches produced by the RU to demonstrate its abibility to reproduce the product. [TRS 961 Annex 7, WHO]
Qualification Threshold
A limit above (>) which a degradation product should be qualified. [ICH Q3A, Q3B]
Qualified Person (QP)
The person defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC. [EU GMP Guide, Annex 16]
Quality
The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity. [ICH Q6A, Q8]
The degree to which a set of inherent properties of a product, system or process fulfills requirements (see ICH Q6A definition specifically for “quality” of drug substance and drug (medicinal) products.). [ICH Q9]
A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
The totality of features and characteristics that bear on the ability of a [medical] device to satisfy fitness-for-use, including safety and performance. [21 CFR Part 820, FDA]
Quality Assurance (QA)
The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained. [EU GMP Guide, Part II, ICH Q7]
A wide-ranging concept covering all matters that individually or collectively inuence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. [Good Distribution Practices for Pharmaceutical Products, WHO, Inspection, WHO]
Proactive and retrospective activities that provide confidence that requirements are fulfilled. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
The actions, planned and performed, to provide confidence that all systems and elements that influence the quality of the product are working as expected individually and collectively. [Canadian GMP Guidelines Annex 14]
Quality Assurance Program
Comprehensive system of an establishment for manufacturing safe, effective, and quality products according to regulatory requirements. This program includes preventing, detecting, and correcting deficiencies that may compromise product quality. [Canadian GMP Guidelines, Annex 14]
Quality Assurance Unit see Quality Control Unit
Quality Attribute
A molecular or product characteristic that is selected for its ability to help indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. [ICH Q5E]
Quality Audit
An examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors. [Inspection, WHO]
A systematic, independent examination of a manufacturer‘s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. [21 CFR Part 820, FDA]
Quality by Design (QbD)
A systematic approach that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management. [EU GMP Guide, Annex 15, ICH Q8]
Quality Control (QC)
Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. [EU GMP Guide, Part I]
Checking or testing that specifications are met. [EU GMP Guide, Part II, ICH Q7]
Covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics. [TRS 961 Annex 7, WHO]
The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
A component of a QA program that includes the activities and controls used to determine the accuracy and reliability of the establishment’s personnel, equipment, reagents, and operations in the fabricating of blood components including testing and product release. [Canadian GMP Guidelines Annex 14]
Quality Control Unit
Any person or organizational element designated by the firm to be responsible for the duties relating to quality control. [21 CFR Part 210, FDA]
An organizational element with authority and responsibility as defined by 21 CFR Part 211.22. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
One or more individuals designated by, and reporting directly to, management with defined authority and responsibility to assure that all quality assurance policies are carried out in the organization. [Canadian GMP Guidelines, Annex 14]
Quality Management (QM)
Accountability for the successful implementation of the quality system. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Manual
Document specifying the quality management system of an organisation. [ISO 9000:2005, ICH Q10]
Quality Objective
A means to translate the quality policy and strategies into measurable activities. [ICH Q10]
Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Plan
The documented result of quality planning that is disseminated to all relevant levels of the organization. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Planning
Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives. [ISO 9000:2005, ICH Q10]
A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Policy (QP)
Overall intentions and direction of an organisation related to quality as formally expressed by senior management. [ISO 9000:2005, ICH Q10]
The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. [21 CFR Part 820, FDA]
A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Risk Management (QRM)
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. [EU GDP Guidelines, ICH Q9, TRS 961 Annex 7, WHO]
A systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. [ICH Q9, Q10, Canadian GMP Guidelines 2009]
Quality System (QS)
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. [EU GDP Guidelines, ICH Q9]
An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality. [Good Distribution Practices for Pharmaceutical Products, WHO]
The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. [21 CFR Part 820, FDA]
Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Target Product Profile (QTPP)
A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. [ICH Q8]
Quality Unit
An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization. [EU GMP Guide, Part II, ICH Q7]
A group organized within an organization to promote quality in general practice. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quantitation Limit
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products. [ICH Q2]
Quarantine
The status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal. [EU GMP Guide, Glossary, Main Principles for Pharmaceutical Products, WHO, PIC/S PE 010-4]
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. [ICH Q7]
Effective restriction of the availability of material or product for use (physically or by system), until released by the quality control department. [Canadian GMP Guidelines 2009]
Produced by the Q4B evaluation process, information concerning how the evaluated pharmacopoeial text can be used. The Q4B Outcome is included as part of the topic-specific Q4B annex developed as a result of each favourable evaluation. [ICH Q4B]
QC Laboratory Inspection
On-Site assessment of the adherence to Good Quality Control Laboratory Practice is normally part of a GMP Inspection. Contract QC Laboratories authorised according to Article 13.1 of Directive 2001/20/EC are also subject to these inspections. Laboratory inspection for compliance with GLP Principles is performed in accordance with guidelines given in the annexes to Directive 90/18/EEC and is not part of this document. Inspections performed in laboratories analysing samples taken from trial subjects are likewise not included.
[Compilation of Community Procedures on Inspections and Exchange of Information, EMA]
Qualification(see also Validation)
Action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification. [EU GMP Guide, Glossary, EU GDP Guidelines, Main Principles for Pharmaceutical Products, WHO]
The process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the level(s) specified. [ICH Q3A, Q3B]
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. [ICH Q7]
The risk based systematic and documented evidence that facilities, rooms or equipment work correctly, are suitable for the intended purpose and actually give the expected results. [PIC/S PE 010-4]
Identification of equipment attributes related to the performance of a particular function or functions and allocation of certain limits or restrictions to those attributes. [PIC/S PI 006-3]
Qualification Batch
Those batches produced by the RU to demonstrate its abibility to reproduce the product. [TRS 961 Annex 7, WHO]
Qualification Threshold
A limit above (>) which a degradation product should be qualified. [ICH Q3A, Q3B]
Qualified Person (QP)
The person defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC. [EU GMP Guide, Annex 16]
Quality
The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity. [ICH Q6A, Q8]
The degree to which a set of inherent properties of a product, system or process fulfills requirements (see ICH Q6A definition specifically for “quality” of drug substance and drug (medicinal) products.). [ICH Q9]
A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
The totality of features and characteristics that bear on the ability of a [medical] device to satisfy fitness-for-use, including safety and performance. [21 CFR Part 820, FDA]
Quality Assurance (QA)
The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained. [EU GMP Guide, Part II, ICH Q7]
A wide-ranging concept covering all matters that individually or collectively inuence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. [Good Distribution Practices for Pharmaceutical Products, WHO, Inspection, WHO]
Proactive and retrospective activities that provide confidence that requirements are fulfilled. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
The actions, planned and performed, to provide confidence that all systems and elements that influence the quality of the product are working as expected individually and collectively. [Canadian GMP Guidelines Annex 14]
Quality Assurance Program
Comprehensive system of an establishment for manufacturing safe, effective, and quality products according to regulatory requirements. This program includes preventing, detecting, and correcting deficiencies that may compromise product quality. [Canadian GMP Guidelines, Annex 14]
Quality Assurance Unit see Quality Control Unit
Quality Attribute
A molecular or product characteristic that is selected for its ability to help indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. [ICH Q5E]
Quality Audit
An examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors. [Inspection, WHO]
A systematic, independent examination of a manufacturer‘s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. [21 CFR Part 820, FDA]
Quality by Design (QbD)
A systematic approach that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management. [EU GMP Guide, Annex 15, ICH Q8]
Quality Control (QC)
Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. [EU GMP Guide, Part I]
Checking or testing that specifications are met. [EU GMP Guide, Part II, ICH Q7]
Covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics. [TRS 961 Annex 7, WHO]
The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
A component of a QA program that includes the activities and controls used to determine the accuracy and reliability of the establishment’s personnel, equipment, reagents, and operations in the fabricating of blood components including testing and product release. [Canadian GMP Guidelines Annex 14]
Quality Control Unit
Any person or organizational element designated by the firm to be responsible for the duties relating to quality control. [21 CFR Part 210, FDA]
An organizational element with authority and responsibility as defined by 21 CFR Part 211.22. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
One or more individuals designated by, and reporting directly to, management with defined authority and responsibility to assure that all quality assurance policies are carried out in the organization. [Canadian GMP Guidelines, Annex 14]
Quality Management (QM)
Accountability for the successful implementation of the quality system. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Manual
Document specifying the quality management system of an organisation. [ISO 9000:2005, ICH Q10]
Quality Objective
A means to translate the quality policy and strategies into measurable activities. [ICH Q10]
Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Plan
The documented result of quality planning that is disseminated to all relevant levels of the organization. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Planning
Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives. [ISO 9000:2005, ICH Q10]
A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Policy (QP)
Overall intentions and direction of an organisation related to quality as formally expressed by senior management. [ISO 9000:2005, ICH Q10]
The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. [21 CFR Part 820, FDA]
A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Risk Management (QRM)
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. [EU GDP Guidelines, ICH Q9, TRS 961 Annex 7, WHO]
A systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. [ICH Q9, Q10, Canadian GMP Guidelines 2009]
Quality System (QS)
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. [EU GDP Guidelines, ICH Q9]
An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality. [Good Distribution Practices for Pharmaceutical Products, WHO]
The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. [21 CFR Part 820, FDA]
Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quality Target Product Profile (QTPP)
A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. [ICH Q8]
Quality Unit
An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization. [EU GMP Guide, Part II, ICH Q7]
A group organized within an organization to promote quality in general practice. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Quantitation Limit
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products. [ICH Q2]
Quarantine
The status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal. [EU GMP Guide, Glossary, Main Principles for Pharmaceutical Products, WHO, PIC/S PE 010-4]
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. [ICH Q7]
Effective restriction of the availability of material or product for use (physically or by system), until released by the quality control department. [Canadian GMP Guidelines 2009]