M
Management with Executive Responsibility
Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer‘s quality policy and quality system. [21 CFR Part 820, FDA]
Manifold
Equipment or apparatus designed to enable one or more gas containers to be filled simultaneously from the same source. [EU GMP Guide, Glossary]
Equipment or apparatus designed to enable one or more gas containers to be emptied and filled at a time. [EU GMP Guide, Annex 6]
A unit for connecting a cylindrical pipe fitting, having a number of lateral outlets, for connecting one pipe with several others used in the Radiosynthesizer Unit. [Canadian GMP Guidelines 2009, Annex 5]
Manufacture / Production
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of medicinal products and the related controls. [EU GMP Guide, Glossary]
All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of APIs and related controls. [EU GMP Guide, Part II, ICH Q7]
Production, quality control and release and delivery of radiopharmaceuticals from the active substance and starting materials. [EU GMP Guide, Annex 3]
All operations of purchase of materials and products, production, quality control, release, storage and distribution of finished products, and the related controls. [Guide to Good Storage Practices for Pharmaceutical Products, WHO]
All operations of purchase of materials and products, production, packaging, labelling, quality control, release, storage and distribution of pharmaceutical products, and the related controls. [Guide to Good Distribution Practices for Pharmaceuticals, WHO]
Part of preparation. It involves all processes and operations in the preparation of a medicinal product, from receipt of materials, through processing and packaging, to its completion as a finished product. [PIC/S PE 010-4]
All operations involved in the preparation of a phase 1 investigational drug from receipt of materials through distribution including processing, storage, packaging, labeling, laboratory testing, and QC. [Guidance for Industry: cGMP for Phase 1 Investigational Drugs, FDA]
(fabrication) All operations including purchase of materials and products, production, quality control, release, storage, distribution and related controls. [Canadian GMP Guidelines 2009, Annex 5]
Manufacturer
Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001/83/EC. [EU GMP Guide, Glossary]
Any person who designs, manufactures, fabricates, assembles, or processes a finished [medical] device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. [21 CFR Part 820, FDA]
A person who takes responsibility for and is involved in any aspect of the manufacture of a phase 1 investigational drug. [Guidance for Industry: cGMP for Phase 1 Investigational Drugs, FDA]
Manufacturer/Importer of Investigational Medicinal Product Any person engaged in activities for which the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required. [EU GMP Guide, Annex 13]
In connection with investigational medicinal products, any holder of the authorisation to manufacture/import. [Canadian GMP Guidelines 2009, Annex 13]
Manufacturing Batch Record
Records demonstrating that the batch of a drug was fabricated in accordance with the approved master production documents. [Canadian GMP Guidelines 2009]
Manufacturing Material
Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished [medical] device as a residue or impurity not by design or intent of the manufacturer. [21 CFR Part 820, FDA]
Manufacturing Scale Production
Manufacture at the scale typically encountered in a facility intended for product production for marketing. [ICH Q5C]
Marker
Chemically defined constituents of a herbal material utilized for control purposes. They may or may not contribute to the clinical efficacy. When they contribute to the clinical efficacy, however, evidence that they are solely responsible for the clinical efficacy may or may not be available. Markers are generally employed when constituents of known therapeutic activity are not known or are not clearly identified, and may be used to identify the herbal material or preparation or calculate their quantity in the finished product. [Specific Pharmaceutical Products, WHO]
Marketing Authorization (product licence, registration certificate)
A legal document issued by the competent drug regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life. [Main Principles for Pharmaceutical Products, WHO]
A legal document issued by the competent medicines regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using INNs or national generic names where they exist), the shelf-life and storage conditions, and packaging characteristics. It species the information on which authorization is based (e.g. “The product(s) must conform to all the details provided in your application and as modified in subsequent correspondence”). It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization. Once a product has been given marketing authorization, it is included on a list of authorized products – the register – and is often said to be “registered” or to “have registration”. Market authorization may occasionally also be referred to as a “licence” or “product licence”. [Good Distribution Practices for Pharmaceutical Products, WHO]
A legal document issued by Health Canada, authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drug Act and its associated Regulations. The marketing authorization may be in the form of a Notice of Compliance (NOC), Drug Identification Number (DIN), a device licence for classes II, III and IV medical devices, or a natural product number (NPN) or homeopathic DIN (DIN-HM). [Canadian GMP Guidelines 2009]
Mass Balance
The process of adding together the assay value and levels of degradation products to see how closely these add up to 100% of the initial value, with due consideration of the margin of analytical error. [ICH Q1A, Canadian CMP-Guidelines 2009]
Master Cell Bank (MCB)
An aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions. The MCB is used to derive all working cell banks. The testing performed on a new MCB (from a previous initial cell clone, MCB or WCB) should be the same as for the MCB, unless justified. [ICH Q5A, Q5B, Q5D]
Master Formula
A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls. [Main Principles for Pharmaceutical Products, WHO]
A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls. [Canadian GMP Guidelines, Annex 3, Annex 5]
Master Production Document (MPD)
Documents that includes specifications for raw material, for packaging material and for packaged dosage form, master formula (including composition and instructions as described in the definition above), sampling procedures, and critical processing related SOPs, whether or not these SOPs are specifically referenced in the master formula. [Canadian GMP Guidelines 2009]
Master Record
A document or set of documents that serve as a basis for the batch documentation (blank batch record). [Main Principles for Pharmaceutical Products, WHO]
Material
A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs and packaging and labelling materials. [EU GMP Guide, Part II, ICH Q7, Guide to Good Storage Practices for Pharmaceuticals, WHO]
Matrixing
The design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations is tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations is tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and, possibly in some cases, different container closure systems. [ICH Q1A]
The concept of matrixing may also apply in other areas such as validation. [Canadian GMP Guidelines 2009]
Maximum Theoretical Residual Impurity
Gaseous impurity from a possible backflow that remains after the cylinder pre-treatment process before filling. The calculation of the maximum theoretical residual impurity is only relevant for compressed gases and assumes that the gases behave as perfect gases. [EU GMP Guide, Annex 6]
Mean Kinetic Temperature
A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation. When establishing the mean kinetic temperature for a defined period, the formula of J. D. Haynes (J. Pharm. Sci., 60:927–929, 1971) can be used. [ICH Q1A]
Media Fill
Method of evaluating an aseptic process using a microbial growth medium. (Media fills are understood to be synonymous to simulated product fills, broth trials, broth fills etc.). [PIC/S PI 007-6]
Medical Gas
Any gas or mixture of gases manufactured, sold or represented for use as a drug. [Canadian GMP Guidelines 2009]
Medical Officer
A person registered and licensed under the laws of a province to practice the profession of medicine. [Canadian GMP Guidelines, Annex 14]
Medicated Premix see Drug Premix
Medicinal Gas
Any gas or mixture of gases classified as a medicinal product (as defined in Directives 2001/83/EC and 2001/82/EC). [EU GMP Guide, Annex 6]
Medicinal Plant
Plant the whole or part of which is used for medicinal purpose. [EU GMP Guide, Glossary] Medicinal plants are plants (wild or cultivated) used for medicinal purposes. [Specific Pharmaceutical Products, WHO]
Medicinal Product
Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product. [EU GMP Guide, Glossary, Directive 2001/83/EC]
Metazoan
Organism of multicellular animal nature. [ICH Q5D]
Method Validation
Method validation is conducted where non-compendial analytical methods are included in the application to confirm that the applicants’ proposed analytical methods are suitable for regulatory purposes. A side-by-side comparison with a compendial method, if available, should be included. Method verification is conducted where the methods are compendial, to confirm whether the product as compounded can be analysed satisfactorily by the official method. [Inspection, WHO]
Minimum Exposure Time
The shortest period for which a treatment step will be maintained. [ICH Q5A]
Minimum Pressure Retention Valve
A cylinder valve, which maintains a positive pressure above atmospheric pressure in a gas cylinder after use, in order to prevent internal contamination of the cylinder. [EU GMP Guide, Annex 6]
Mobile Cyrogenic Vessel
Mobile thermally insulated container designed to maintain the contents in a liquid state. In the Annex, this term does not include the tankers. [EU GMP Guide, Annex 6]
Modified Release
Dosage forms whose drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as a solution or an immediate release dosage form. Modified release solid oral dosage forms include both delayed and extended release drug products. [ICH Q6A]
Modifying Factor
A factor determined by professional judgment of a toxicologist and applied to bioassay data to relate that data safely to humans. [ICH Q3C]
Monitor
A person appointed by, and responsible to, the sponsor for monitoring and reporting the progress of the trial and for the verification of data. [Specific Pharmaceutical Products, WHO] The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control. [Hazard and Risk Analysis in Pharmaceutical Products, WHO]
Monosepsis (axenic)
A single organism in culture which is not contaminated with any other organism. [EU GMP Guide, Annex 2]
Mother Liquor
The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the API and/or impurities. It may be used for further processing. [EU GMP Guide, Part II, ICH Q7, Chinese GMP Guidelines, Annex 2]
MRA Country
A country that is a participant to a mutual recognition agreement with Canada. [Canadian GMP Guidelines 2009]
Multi-Centre Clinical Trial
A clinical trial conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the trial sites may be located in a single Member State, in a number of Member States and/or in Member States and third countries. [Directive 2001/20/EC]
Multi-suite Complex
(complexe multi-suites) Facility where each suite is dedicated to the fabrication of a biological drug. Suites are located within the same building and are independent from one another. [Canadian GMP Guidelines, Annex 2]
Multi-use Area
(aire polyvalente) Area where more than one biological drug substance or drug product is manufactured. Manufacturing is either concurrent or on a campaign basis. [Canadian GMP Guidelines, Annex 2]
Multiple-Dose-Container
(récipient multi-doses) Container that permits withdrawal of successive portions of the contents without changing the strength, quality or purity of the remaining portion for articles intended for parenteral use only. [Canadian GMP Guidelines, Annex 3]
Multiproduct
More than one approved product, licensed product, IND drug, or separate process. [Guidance for Industry: cGMP for Phase 1 Investigational Drugs, FDA]
Multiproduct Facility
A facility that manufactures, either concurrently or in campaign mode, a range of different biological medicinal substances and products and within which equipment train(s) may or may not be dedicated to specific substances or products. [EU GMP Guide, Annex 2]
Mutual Recognition Agreement (MRA)
The “appropriate arrangement” between the Community and an exporting third country mentioned in Article 51(2) of Directive 2001/83/EC and Article 55(2) of Directive 2001/82/EC. [EU GMP Guide, Annex 16] (accord de reconnaissance mutuelle (ARM)) An international agreement that provides for the mutual recognition of compliance certification for Good Manufacturing Practices for drugs. [Canadian GMP Guidelines 2009]
Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer‘s quality policy and quality system. [21 CFR Part 820, FDA]
Manifold
Equipment or apparatus designed to enable one or more gas containers to be filled simultaneously from the same source. [EU GMP Guide, Glossary]
Equipment or apparatus designed to enable one or more gas containers to be emptied and filled at a time. [EU GMP Guide, Annex 6]
A unit for connecting a cylindrical pipe fitting, having a number of lateral outlets, for connecting one pipe with several others used in the Radiosynthesizer Unit. [Canadian GMP Guidelines 2009, Annex 5]
Manufacture / Production
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of medicinal products and the related controls. [EU GMP Guide, Glossary]
All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of APIs and related controls. [EU GMP Guide, Part II, ICH Q7]
Production, quality control and release and delivery of radiopharmaceuticals from the active substance and starting materials. [EU GMP Guide, Annex 3]
All operations of purchase of materials and products, production, quality control, release, storage and distribution of finished products, and the related controls. [Guide to Good Storage Practices for Pharmaceutical Products, WHO]
All operations of purchase of materials and products, production, packaging, labelling, quality control, release, storage and distribution of pharmaceutical products, and the related controls. [Guide to Good Distribution Practices for Pharmaceuticals, WHO]
Part of preparation. It involves all processes and operations in the preparation of a medicinal product, from receipt of materials, through processing and packaging, to its completion as a finished product. [PIC/S PE 010-4]
All operations involved in the preparation of a phase 1 investigational drug from receipt of materials through distribution including processing, storage, packaging, labeling, laboratory testing, and QC. [Guidance for Industry: cGMP for Phase 1 Investigational Drugs, FDA]
(fabrication) All operations including purchase of materials and products, production, quality control, release, storage, distribution and related controls. [Canadian GMP Guidelines 2009, Annex 5]
Manufacturer
Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001/83/EC. [EU GMP Guide, Glossary]
Any person who designs, manufactures, fabricates, assembles, or processes a finished [medical] device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. [21 CFR Part 820, FDA]
A person who takes responsibility for and is involved in any aspect of the manufacture of a phase 1 investigational drug. [Guidance for Industry: cGMP for Phase 1 Investigational Drugs, FDA]
Manufacturer/Importer of Investigational Medicinal Product Any person engaged in activities for which the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required. [EU GMP Guide, Annex 13]
In connection with investigational medicinal products, any holder of the authorisation to manufacture/import. [Canadian GMP Guidelines 2009, Annex 13]
Manufacturing Batch Record
Records demonstrating that the batch of a drug was fabricated in accordance with the approved master production documents. [Canadian GMP Guidelines 2009]
Manufacturing Material
Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished [medical] device as a residue or impurity not by design or intent of the manufacturer. [21 CFR Part 820, FDA]
Manufacturing Scale Production
Manufacture at the scale typically encountered in a facility intended for product production for marketing. [ICH Q5C]
Marker
Chemically defined constituents of a herbal material utilized for control purposes. They may or may not contribute to the clinical efficacy. When they contribute to the clinical efficacy, however, evidence that they are solely responsible for the clinical efficacy may or may not be available. Markers are generally employed when constituents of known therapeutic activity are not known or are not clearly identified, and may be used to identify the herbal material or preparation or calculate their quantity in the finished product. [Specific Pharmaceutical Products, WHO]
Marketing Authorization (product licence, registration certificate)
A legal document issued by the competent drug regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life. [Main Principles for Pharmaceutical Products, WHO]
A legal document issued by the competent medicines regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using INNs or national generic names where they exist), the shelf-life and storage conditions, and packaging characteristics. It species the information on which authorization is based (e.g. “The product(s) must conform to all the details provided in your application and as modified in subsequent correspondence”). It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization. Once a product has been given marketing authorization, it is included on a list of authorized products – the register – and is often said to be “registered” or to “have registration”. Market authorization may occasionally also be referred to as a “licence” or “product licence”. [Good Distribution Practices for Pharmaceutical Products, WHO]
A legal document issued by Health Canada, authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drug Act and its associated Regulations. The marketing authorization may be in the form of a Notice of Compliance (NOC), Drug Identification Number (DIN), a device licence for classes II, III and IV medical devices, or a natural product number (NPN) or homeopathic DIN (DIN-HM). [Canadian GMP Guidelines 2009]
Mass Balance
The process of adding together the assay value and levels of degradation products to see how closely these add up to 100% of the initial value, with due consideration of the margin of analytical error. [ICH Q1A, Canadian CMP-Guidelines 2009]
Master Cell Bank (MCB)
An aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions. The MCB is used to derive all working cell banks. The testing performed on a new MCB (from a previous initial cell clone, MCB or WCB) should be the same as for the MCB, unless justified. [ICH Q5A, Q5B, Q5D]
Master Formula
A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls. [Main Principles for Pharmaceutical Products, WHO]
A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls. [Canadian GMP Guidelines, Annex 3, Annex 5]
Master Production Document (MPD)
Documents that includes specifications for raw material, for packaging material and for packaged dosage form, master formula (including composition and instructions as described in the definition above), sampling procedures, and critical processing related SOPs, whether or not these SOPs are specifically referenced in the master formula. [Canadian GMP Guidelines 2009]
Master Record
A document or set of documents that serve as a basis for the batch documentation (blank batch record). [Main Principles for Pharmaceutical Products, WHO]
Material
A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs and packaging and labelling materials. [EU GMP Guide, Part II, ICH Q7, Guide to Good Storage Practices for Pharmaceuticals, WHO]
Matrixing
The design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations is tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations is tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and, possibly in some cases, different container closure systems. [ICH Q1A]
The concept of matrixing may also apply in other areas such as validation. [Canadian GMP Guidelines 2009]
Maximum Theoretical Residual Impurity
Gaseous impurity from a possible backflow that remains after the cylinder pre-treatment process before filling. The calculation of the maximum theoretical residual impurity is only relevant for compressed gases and assumes that the gases behave as perfect gases. [EU GMP Guide, Annex 6]
Mean Kinetic Temperature
A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation. When establishing the mean kinetic temperature for a defined period, the formula of J. D. Haynes (J. Pharm. Sci., 60:927–929, 1971) can be used. [ICH Q1A]
Media Fill
Method of evaluating an aseptic process using a microbial growth medium. (Media fills are understood to be synonymous to simulated product fills, broth trials, broth fills etc.). [PIC/S PI 007-6]
Medical Gas
Any gas or mixture of gases manufactured, sold or represented for use as a drug. [Canadian GMP Guidelines 2009]
Medical Officer
A person registered and licensed under the laws of a province to practice the profession of medicine. [Canadian GMP Guidelines, Annex 14]
Medicated Premix see Drug Premix
Medicinal Gas
Any gas or mixture of gases classified as a medicinal product (as defined in Directives 2001/83/EC and 2001/82/EC). [EU GMP Guide, Annex 6]
Medicinal Plant
Plant the whole or part of which is used for medicinal purpose. [EU GMP Guide, Glossary] Medicinal plants are plants (wild or cultivated) used for medicinal purposes. [Specific Pharmaceutical Products, WHO]
Medicinal Product
Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product. [EU GMP Guide, Glossary, Directive 2001/83/EC]
Metazoan
Organism of multicellular animal nature. [ICH Q5D]
Method Validation
Method validation is conducted where non-compendial analytical methods are included in the application to confirm that the applicants’ proposed analytical methods are suitable for regulatory purposes. A side-by-side comparison with a compendial method, if available, should be included. Method verification is conducted where the methods are compendial, to confirm whether the product as compounded can be analysed satisfactorily by the official method. [Inspection, WHO]
Minimum Exposure Time
The shortest period for which a treatment step will be maintained. [ICH Q5A]
Minimum Pressure Retention Valve
A cylinder valve, which maintains a positive pressure above atmospheric pressure in a gas cylinder after use, in order to prevent internal contamination of the cylinder. [EU GMP Guide, Annex 6]
Mobile Cyrogenic Vessel
Mobile thermally insulated container designed to maintain the contents in a liquid state. In the Annex, this term does not include the tankers. [EU GMP Guide, Annex 6]
Modified Release
Dosage forms whose drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as a solution or an immediate release dosage form. Modified release solid oral dosage forms include both delayed and extended release drug products. [ICH Q6A]
Modifying Factor
A factor determined by professional judgment of a toxicologist and applied to bioassay data to relate that data safely to humans. [ICH Q3C]
Monitor
A person appointed by, and responsible to, the sponsor for monitoring and reporting the progress of the trial and for the verification of data. [Specific Pharmaceutical Products, WHO] The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control. [Hazard and Risk Analysis in Pharmaceutical Products, WHO]
Monosepsis (axenic)
A single organism in culture which is not contaminated with any other organism. [EU GMP Guide, Annex 2]
Mother Liquor
The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the API and/or impurities. It may be used for further processing. [EU GMP Guide, Part II, ICH Q7, Chinese GMP Guidelines, Annex 2]
MRA Country
A country that is a participant to a mutual recognition agreement with Canada. [Canadian GMP Guidelines 2009]
Multi-Centre Clinical Trial
A clinical trial conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the trial sites may be located in a single Member State, in a number of Member States and/or in Member States and third countries. [Directive 2001/20/EC]
Multi-suite Complex
(complexe multi-suites) Facility where each suite is dedicated to the fabrication of a biological drug. Suites are located within the same building and are independent from one another. [Canadian GMP Guidelines, Annex 2]
Multi-use Area
(aire polyvalente) Area where more than one biological drug substance or drug product is manufactured. Manufacturing is either concurrent or on a campaign basis. [Canadian GMP Guidelines, Annex 2]
Multiple-Dose-Container
(récipient multi-doses) Container that permits withdrawal of successive portions of the contents without changing the strength, quality or purity of the remaining portion for articles intended for parenteral use only. [Canadian GMP Guidelines, Annex 3]
Multiproduct
More than one approved product, licensed product, IND drug, or separate process. [Guidance for Industry: cGMP for Phase 1 Investigational Drugs, FDA]
Multiproduct Facility
A facility that manufactures, either concurrently or in campaign mode, a range of different biological medicinal substances and products and within which equipment train(s) may or may not be dedicated to specific substances or products. [EU GMP Guide, Annex 2]
Mutual Recognition Agreement (MRA)
The “appropriate arrangement” between the Community and an exporting third country mentioned in Article 51(2) of Directive 2001/83/EC and Article 55(2) of Directive 2001/82/EC. [EU GMP Guide, Annex 16] (accord de reconnaissance mutuelle (ARM)) An international agreement that provides for the mutual recognition of compliance certification for Good Manufacturing Practices for drugs. [Canadian GMP Guidelines 2009]