Glossary

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  • Aeration system
    Integrates supply and return fans, cooling and heating coils, dehumidifiers and filtration stations.
  • ASHRAE
    (American Society of Heating, Refrigerating and Air Conditioning Engineers): The American Society of Heating, Refrigerating and Air Conditioning Engineers is the international technical association dedicated to improving the quality of life through technological advances related to heating, refrigerating, air conditioning and ventilation (HVACR).
  • ASQ
    (American Society of Quality). The American Society of Quality is a global community of professionals and organizations from around the world that are dedicated to quality and who share the concepts and tools so that communities, corporations, and organizations from all over the world can face the challenges of the future. ASQ provides training, professional certifications and knowledge to a wide network of contacts in the global community of quality specialists.
  • BPAv
    (Good Storage Practices Ongoing): Is that part of quality assurance which ensures that the quality of the drug product is maintained through appropriate controls during storage.
  • BPCv
    (Good Distribution Practice Ongoing): A set of guidelines for the pharmaceutical industry, to ensure the safety of pharmaceutical products during transportation or storage. Compliance with the requirements of GDP proof that organizations can supply good quality as desired by pharmaceutical manufacturers, thus acting in the health sector as a crucial partner of the healthcare supply chain.
  • BPDv
    (Good Distribution Practice Ongoing): A set of guidelines for the pharmaceutical industry, to ensure the safety of pharmaceutical products during transportation or storage. Compliance with the requirements of GDP proof that organizations can supply good quality as desired by pharmaceutical manufacturers, thus acting in the health sector as a crucial partner of the healthcare supply chain
  • BPIv
    (Good Engineering Practices Ongoing): Best Practices of Engineering can be defined as the establishment of methods and engineering standards that applied throughout the lifecycle of a project allow solutions deliver adequate and cost - effective according to the needs client.
  • BPLv
    (Good Laboratory Practice Ongoing): Good Laboratory Practice is a set of operational procedures and practices established and promulgated by certain bodies such as the (Organization for Economic Cooperation and Development (OECD) or the Food and Drug Administration (FDA) which is considered mandatory to ensure the quality and integrity of the data produced in certain types of research or studies.
  • BPMv 
    (Good Manufacturing Practices Ongoing): A set of guidelines applicable to the manufacturing operations of drugs, cosmetics, medical products and food in their final retail forms including large-scale processes in hospitals and preparing supplies for use in clinical trials for drugs. 
  • CAPA
    (Program for Corrective and Preventive Actions): Document that defines the priorities, dates, and people responsible for the solution of the non-compliances found.  
  • cGCP
    (current Good Clinical Practices): A standard for clinical studies that include the design, behavior, monitoring, finishing, inspection, analysis, report, and documentation of the studies; that ensure that these are from a solid scientific and ethical standpoint, and that the clinical properties of the pharmaceutical products (diagnostic, therapeutic, or preventive) under investigation are properly documented.
  • cGDP
    (current Good Distribution Practices): Set of guides for the pharmaceutical industry to guarantee the safety of pharmaceutical products during transportation or storage. The compliance with the requirements of GDP proves that the organizations can provide high quality products as desired by manufacturers of pharmaceutical products, and in this way acting within the health area as a vital partner in the sanitary supply chain.  
  • cGEP
    (current Good Engineering Practices): Good Engineering Practices can be defined as the creation of engineering methods and standards. When these are applied throughout the lifecycle of a project, they inhibit providing adequate and cost-effective solutions in accordance with the needs of the client.
  • cGLP
    (current Good Laboratory Practices) Good Laboratory Practices, are a set of operational procedures and practices established and published by certain organizations such as the Organization for Economic Cooperation and Development (OCDE), or the Food and Drug Administration (FDA), that are considered mandatory to ensure the quality and integrity of the data produced in determined types of investigation or studies.
  • cGMP
    (current Good Manufacturing Process): A set of guides, applicable to the manufacturing of medicine, cosmetics, medical products and food, in their final form sold to the public, including the large scale processes in hospitals and the preparation of supplies for use in clinical trials in the case of medicine.
  • cGSP
    (current Good Storage Practices): The part of the Quality assurance that guarantees that the quality of the pharmaceutical product is kept through proper means of control throughout its storage.
  • Ciclo de Vida 
    A life cycle approach involves defining and implementing activities in a systematic way from conception, understanding of requirements through the development, launch and operational use until retirement system.
  • Clean steam
    Is one that comes from a steam generator, preferably of stainless steel, the feed water is purified water.
  • Cleanroom
    It is a room specially designed with defined particle control and microbial contamination, constructed and used such that the introduction, generation and retention of contaminants within the area is reduced. (Source WHO report 48).
  • Contaminante 
    Any particle, molecular or not, with biological features or not, that can negatively impact the product or process.
  • Control de cambios 
    Any changes to equipment, systems, processes or procedures can change the parameters or affect the expected results. Therefore, all changes made after approval must be controlled.
  • Critical Process Parameter
    Those operating variables which can be assigned values that are used as control levels and have direct impact on product quality.
  • Critical Quality Attribute
    Specifications for the product at different stages of the process, which has impact on safety, effectiveness, purity and power of the pharmaceutical.
  • Desviaciones 
    La desviación típica o desviación estándar (denotada con el símbolo σ o s, dependiendo de la procedencia del conjunto de datos) es una medida de dispersión para variables de razón (variables cuantitativas o cantidades racionales) y de intervalo. Se define como la raíz cuadrada de la varianza de la variable.
  • DQ
    The documented evidence that the design of a system complies with quality standards in accordance with that stated in the URS (user requirements specifications), FDS (functional design specifications) and DDS (detailed design specifications) of the equipment’s design.
  • Dry Steam
    Also called dry saturated steam is steam that has been completely evaporated, that is, does not contain drops of liquid water.
  • EMA
    The documented evidence that the design of a system complies with quality standards in accordance with that stated in the URS (user requirements specifications), FDS (functional design specifications) and DDS (detailed design specifications) of the equipment’s design.  
  • FDA
    (Food and Drug Administration): US Food and Drug Administration is the agency of the US government responsible for regulating food (for both people and animals), drugs (human and veterinary), cosmetics, medical devices (human and animal), biologics and blood derived products.
  • FDS
    Functional description of the system
  • Filtering steam
    Vapor is passed plant through a stainless steel filter of 10 to 20 microns to remove particles: generally presents the same problems seen in the plant steam but smaller.
  • FMECA
    Analysis of the critical nature that can be based on the probability of the fault mode causing the fault in the system, or the risk level associated with the fault mode, or the risk’s priority number. 
  • GAMP
    Good Automated Manufacturing Practice It is a trademark of the International Society for Pharmaceutical Engineering (ISPE) brand. ISPE guide The Good Automated Manufacturing Practice (GAMP) Guide for validation of automated systems in pharmaceutical production describes a set of principles and procedures that help ensure that products have the required quality.
  • Gas systems
    Within these systems is the compressed air system, systems of nitrogen, oxygen and CO2. Its purpose is to create conditions of temperature, humidity and cleanliness (particulate) air, adequate to the requirements of area classification for different industrial processes.
  • GXP
    (good practices and regulatory compliance): Refers to quality guidelines, rules and regulations. These are used in many fields, including the pharmaceutical and food industries.
  • HACPP
    (Hazard Analysis and Critical Control Points): HACCP are the initials for"Hazard Analysis and Critical Control Points". The United States Department of Agriculture (USDA) considers the application of HACCP in the meat and poultry industry as a control system for processes that can be used to avoid risks in the supply of food and as a tool to control, reduce, and prevent pathogens in meat and poultry. To learn more, visit the FSIS website for "HACCP Guidance".
  • HAZOP
    A technique for identifying risks based on the premise that risks, accidents or operational problems that occur or arise due to a deviation in the variables of a process with regards to the normal parameters of operation in an established system and in a determined stage.
  • HVAC
    Heating, ventilation and air conditioning.
  • ICH
    (International Conference on Harmonization): The International Conference on Harmonization of Technical Requirements for the Registration of Medicine for Human Use (ICH) is unique in its purpose of uniting the regulating authorities and the pharmaceutical industries of Europe, Japan and USA to discuss technical and scientific aspects of the regulation of medicine. ICH is a collective initiative that involves both the regulators and the industry based on investigation focusing on technical requirements of medical products containing new medicine.
  • INVIMA
    (National Institute of Food and Drug Surveillance of Colombia): The INVIMA is the government health authority exercising functions of Inspection, Monitoring and Control of food, drugs and medical devices. (www.invima.gov, co)
  • IQ
    It is documented evidence that all aspects concerning the installation of equipment / sietmascumple specifications approved design and installation of equipment has been safely and according to the standards of Good Manufacturing Practices (GPVD).  
  • IQNET
    It is a certification body of international scope, which brings together more than 30 leading certification bodies in different countries. Some of the certifying entities involved in IQNet are: AENOR (Spain), AFNOR (France), AIB (Belgium), ANCE, IMNC (Mexico), APCER (Portugal), CCC CSIQ (Italy), CQC (China) , CQS (Czech Republic), Cro Cert (Crocacia), DQS (Germany), DS (Denmark), ELOT (Greece), FCAV (Brazil), FONDONORMA (Venezuela), HKQAA (Hong Kong), ICONTEC (Colombia), Inspecta (Finland), IRAM (Argentina), JQA (Japan), KFQ (Korea), MSZT (Hungary), Nemko AS (Norway), NSAI (Ireland), PCBC (Poland), Quality Austria (Austria), RR (Russia) , SIQ (Slovenia), SQS (Switzerland), SRAC (Romania), TSE (Turkey), YUQS (Serbia), AFNOR, CISQ, DQS, NSAI (USA), etc.
  • ISO
    (International Organization for Standardization): The International Organization for Standardization, or ISO is the body responsible for promoting the development of international standards of manufacturing, commerce and communication for all industries
  • Isoplane
    It is a plane that is a visual representation of a three dimensional object in two dimensions, mainly used to display the layout of a circuit piping.
  • ISP
    The Institute of Public Health of Chile is under the Ministry of Health health authority that performs in various areas of health, such as quality assessment laboratories, disease surveillance, control and monitoring of drugs, cosmetics and medical devices, environmental health, occupational health, production and quality control of vaccines, among others.
  • ISPE
    (International Society of Pharmaceutical Engineers): The International Society of Pharmaceutical Engineers Association is the largest nonprofit world dedicated to the education and development of professionals in the pharmaceutical industry, both manufacturers and suppliers sector. It was founded in 1980 and currently has more than 25,000 associates in 90 countries.
  • IVT
    (Institute of Validation Technology) Network Institute of Technology Validation is the greatest resource of information for professionals validation. Their focus is to provide regulatory guidance and industry through peer-reviewed journals, special editions, protocols, training videos, conferences and network events.
  • OCDE
    (Organization for Economic Cooperation and Development): Organization for Economic Cooperation and Development (OECD)
  • OMS
    (World Health Organization): WHO is the directing and coordinating authority for health within the United Nations system. It is responsible to play a leadership role in global health matters, shaping the agenda of health research, setting standards, articulating policy options based on evidence, providing technical support to countries and monitoring and assessing health trends.
  • OPS
    (Pan American Health Organization): The Pan American Health Organization (PAHO) is an international public health agency dedicated to improving the health and living conditions of the peoples of the Americas. It is part of the United Nations System and Regional Office for the Americas of the World Health Organization. PAHO is also specialized in health OAS Inter-American System (OAS) agency. 
  • OQ
    There is documentary evidence that the equipment / system operates in a reproducible manner and according to the specifications set for your design, showing that the equipment operates as intended.
  • OTEC
    (Technical Education Training Agency): These are institutions accredited by the SENCE exclusively to implement training activities that can be attributed to the Franchise Tax and being hired by the Service for the execution of courses financed with public funds.
  • P&ID
    It is a diagram showing the interconnection of process equipment and instruments used for control.  
  • Particle
    They are solid or liquid parts, which are controlled for classification of air cleanliness. The sizes range from 0.1 .mu.m control (lower limit) and 5 µm.
  • PDA
    (Parentheral Drug Association): Parenteral Drug Association, PDA is the main technical organization authorized and recognized in the field of science and technology parenteral. Develop technical reports and responses to regulatory initiatives, PDA, influencing the development of the technology of pharmaceuticals.
  • Piping 
    Referred to the pipes for transporting fluids, product or service for a given process.
  • PMI
    (Project Management Institute): It is one of the largest  professional associations in the world with half a million members and certification holders in 180 countries. It is a non-profit organization improving the profession of project management through world renowned standards and certifications, through cooperation communities, and a vast research program and career opportunities.
  • PQ
    Provide documented evidence to support that the equipment performs in a reproducible manner and in accordance with the specifications established for its design, and that all critical aspects of the performance have been considered adequately.
  • QIMS
    (Quality Intelligence Management System)
  • Riboflavin
    The cleaning requirements in the pharmaceutical industry and associated companies are generally very strict and they must often use cleaning materials in accordance with FDA regulations. In many cases, the cleaning requirements for tanks and reactors in the process require validations of the cleaning with riboflavin tests as part of the approval of the production processes. In addition, it is cleaned with expensive products, so it seems critical to minimize the waste effluents used in the cleaning process.
  • Senior System Support
    (Water systems, gas systems, aeration and steam systems): Support systems are structural part within the pharmaceutical industry; the different processes make use of these and quality extends to the production units.
  • SIP
    (Sterilization-In-Place): On site sterilization system that is widely used within the pharmaceutical and biotechnology industry as companies are making an effort to increase the sterilization assurance associated with products created by the aseptic processing. 
  • Sistema Computarizado 
    A computer system consists of hardware, software and network components, along with control functions and associated documentation.
  • Steam plant
    Also called steam line, relates that generated by a kettle or cauldron that uses chemically treated water supply.
  • Steam systems
    The steam system is designed to generate, distribute and use steam to leverage its temperature and calorific value.
  • Superheated steam
    It is that which is obtained when the steam temperature is higher than its share of the pressure it supports. If heat transfer continues after which all the water has evaporated, the vapor temperature will increase.
  • URS
    (User requirement specifications): Corresponds to the user's requirement specifications, which are formalized in a document where these aspects constituting the foundation for the project's technical, regulatory and legal considerations are described.
  • Validation
    Consists in the elaboration and execution of protocols through tests showing that the aforementioned requirements are in compliance with their primary function. These tests are established in three qualification phases of installation, operation and performance qualification (IQ, OQ and PQ, respectively). In the latter, validation tests of sterilization cycles are also defined.
  • Validation Master Plan (VMP)
    The validation master plan [PMV] specific and coordinates all activities of qualification / validation to ensure that the manufacture of pharmaceuticals are run according to the quality standards required by regulatory agencies.
  • Water systems
    Principal support system that provides different types of water: Drinking water, purified water and water for injection. The water substance, raw material or ingredient widely used in the production, processing and product formulation are.
  • WBS 
    (Work Breakdown Structure):  or (EDT, by its Spanish initials) in project management hierarchical breakdown of work to be executed by the project's team, in order to accomplish the goals of the aforementioned and create required deliverables, with each descending level of the WBS, representing a definition with an increased detail of the project's work.
  • wet steam
    Also called supersaturated vapor is a vapor containing condensed water, usually in the form of droplets (fog).
  • WHO
    The organization of the United Nations (UN) specialized in managing policies for the prevention, promotion and intervention of health on a global scale. It was initially organized by the Economic and Social Council of the United Nations which promoted the drafting of the first statutes of the WHO. The first WHO meeting took place in Geneva in 1948.

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