The never-ending list of Acronyms within the pharmaceutical, biotechnology and medical device fields (leaning toward quality and regulatory)
| 21 CFR | Title 21 of the Code of Federal Regulations | Set of regulations by the FDA for food and drugs |
| 510(k) | Premarket Notification | Notification for marketing medical devices |
| ADR | Adverse Drug Reaction | Undesirable reaction to a drug |
| AHU | Air Handling Unit | Equipment used to regulate and circulate air in HVAC systems |
| ALCOA | Attributable, Legible, Contemporaneous, Original, Accurate | Principles for data integrity |
| ANSI | American National Standards Institute | Organization that oversees the development of voluntary consensus standard |
| ANVISA | Agência Nacional de Vigilância Sanitária | Brazilian Health Regulatory Agency |
| API | Active Pharmaceutical Ingredient | Active ingredient in a pharmaceutical drug |
| AQAP | All Quality Assurance Procedures | Comprehensive procedures for quality assurance |
| ASHRAE | American Society of Heating, Refrigerating and Air-Conditioning Engineers | Professional association focused on HVAC systems |
| ASME | American Society of Mechanical Engineers | Professional association for mechanical engineers |
| ASTM | American Society for Testing and Materials | International standards organization that develops and publishes voluntary consensus technical standards |
| BAM | Bacteriological Analytical Manual | Manual for analysis of microbiological products |
| BMR | Batch Manufacturing Record | Record of the manufacturing process for a batch |
| BOM | Bill of Materials | List of components and quantities needed to manufacture a product |
| BPD | Biologics License Application | Application submitted to FDA for approval to market a biologic product |
| CAD | Computer-Aided Design | Use of computer systems to assist in the creation, modification, analysis, or optimization of a design |
| CAM | Computer-Aided Manufacturing | Use of computer software to control machine tools and related machinery in the manufacturing process |
| CAPA | Corrective and Preventive Actions | Actions taken to address and prevent issues |
| CBE | Changes Being Effected | Submission for changes to an approved application |
| CBER | Center for Biologics Evaluation and Research | FDA division responsible for regulation of biologic products |
| CDRH | Center for Devices and Radiological Health | FDA division responsible for regulation of medical devices |
| CE | Conformité Européenne | European conformity marking for products |
| CFR | Code of Federal Regulations | Compilation of regulations issued by federal agencies in the United States |
| CIP | Clean-in-Place | Method of cleaning equipment without disassembly |
| CMC | Chemistry, Manufacturing, and Controls | Regulatory submission describing the manufacturing process of a drug |
| COA | Certificate of Analysis | Document certifying product meets specifications |
| COC | Certificate of Compliance | Document certifying compliance with regulations |
| COGMP | Code of Good Manufacturing Practice | Guidelines for manufacturing quality products |
| COP | Clean-out-of-Place | Method of cleaning equipment by disassembly |
| COSHH | Control of Substances Hazardous to Health | UK regulations for control of hazardous substances |
| CPMP | Committee for Proprietary Medicinal Products | Former EU committee responsible for medicinal product regulation |
| CRO | Contract Research Organization | Company contracted to conduct research on behalf of another company |
| CSS | Corrective and Preventive Services | Corrective and preventive actions for services |
| CSSR | Cumulative Sum of Squares Residuals | Statistical method used in quality control to monitor process variation |
| CTD | Common Technical Document | Standardized format for regulatory submissions |
| DCS | Distributed Control System | Control system used to control processes or machinery |
| DFM | Design for Manufacturability | Design approach to optimize ease of manufacturing |
| DHF | Design History File | File documenting the design history of a device |
| DHR | Device History Record | Record of production and inspection of a device |
| DMF | Drug Master File | File containing information on a drug’s manufacturing |
| DMR | Device Master Record | Document containing specifications and procedures for a medical device |
| DMSO | Drug Master File/Drug Master Sample | File containing detailed information about the quality and purity of a drug |
| DOE | Design of Experiments | Statistical method for planning, conducting, and analyzing experiments |
| DPD | Drug Product Database | Database of drug products available in Canada |
| DQ | Design Qualification | Process of verifying that the design of a system meets specified requirements |
| DQSA | Drug Quality and Security Act | U.S. law aimed at improving drug safety and security |
| DSCSA | Drug Supply Chain Security Act | U.S. law regulating pharmaceutical supply chain |
| DSUR | Development Safety Update Report | Periodic report summarizing the safety data of a drug during clinical development |
| EC | European Commission | Executive body responsible for proposing legislation and implementing decisions in the EU |
| eCTD | Electronic Common Technical Document | Electronic submission format for regulatory documents |
| ELN | Electronic Laboratory Notebook | Digital system for recording laboratory data |
| EM | Environmental Monitoring | Monitoring of environmental conditions |
| EMA | European Medicines Agency | Agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU |
| EMEA | European Medicines Agency | Former name of the EMA |
| EP | European Pharmacopoeia | Reference book of quality standards for pharmaceutical substances |
| FAT | Factory Acceptance Testing | Testing performed to ensure equipment meets specifications before installation |
| FDA | Food and Drug Administration | U.S. regulatory agency responsible for protecting public health by regulating food, drugs, and medical devices |
| FMEA | Failure Mode and Effects Analysis | Method for identifying potential failure modes of a system and their effects |
| FMECA | Failure Modes, Effects, and Criticality Analysis | Enhanced form of FMEA that also assesses criticality of failures |
| GCP | Good Clinical Practices | Standards for conducting clinical trials |
| GDP | Good Distribution Practice | Standards for the distribution of pharmaceutical products |
| GLP | Good Laboratory Practice | Quality system for ensuring the integrity of non-clinical laboratory studies |
| GMP | Good Manufacturing Practice | Quality assurance system ensuring products are consistently produced and controlled to meet quality standards |
| GVP | Good Pharmacovigilance Practice | Set of guidelines for the detection, assessment, understanding, and prevention of adverse effects of medicines |
| HACCP | Hazard Analysis and Critical Control Points | Systematic preventive approach to food safety |
| HAZOP | Hazard and Operability Study | Systematic approach to identifying and assessing the potential hazards and operability issues of a process system |
| HHS | Department of Health and Human Services | U.S. government department responsible for protecting the health of all Americans and providing essential human services |
| HPLC | High-Performance Liquid Chromatography | Analytical technique used to separate, identify, and quantify components in a mixture |
| HVAC | Heating, Ventilation, and Air Conditioning | Systems providing environmental control in facilities |
| ICH | International Council for Harmonisation | Global organization working to standardize regulatory requirements for pharmaceuticals |
| ICSR | Individual Case Safety Report | Report of adverse events related to a drug |
| IDE | Investigational Device Exemption | Permission to use unapproved medical devices in trials |
| IEC | International Electrotechnical Commission | International standards organization that prepares and publishes international standards |
| IND | Investigational New Drug | Application for testing a new drug |
| IQ | Installation Qualification | Documentation and verification process to ensure equipment is properly installed |
| IRB | Institutional Review Board | Ethics committee overseeing human subject research |
| ISO | International Organization for Standardization | International standards organization that develops and publishes voluntary consensus technical standards |
| IT | Information Technology | Use of computer systems to store, retrieve, transmit, and manipulate data or information |
| IVD | In Vitro Diagnostic | Diagnostic test performed outside of the body |
| IVDD | In Vitro Diagnostic Device | Medical device intended for in vitro diagnostic use |
| IVDMD | In Vitro Diagnostic Medical Device | Medical device used in vitro for diagnosing diseases |
| LAL | Limulus Amebocyte Lysate | Substance derived from horseshoe crab blood used to detect bacterial endotoxins in pharmaceutical products |
| LIMS | Laboratory Information Management System | Software-based solution for managing laboratory data and operations |
| MAA | Marketing Authorization Application | Application for marketing authorization in Europe |
| MBR | Master Batch Record | Document specifying the manufacturing instructions for a batch of a pharmaceutical product |
| MDR | Medical Device Regulation | Regulation for medical device safety |
| MES | Manufacturing Execution System | System used to manage and control manufacturing operations |
| MOA | Mode of Action | Mechanism by which a drug exerts its effect |
| MRA | Mutual Recognition Agreement | Agreement between regulatory authorities |
| MTBF | Mean Time Between Failures | Average time between failures of a system or component |
| NDA | New Drug Application | Application for marketing a new drug |
| NDC | National Drug Code | Unique identifier for human drugs in the U.S. |
| NDS | New Drug Submission | Submission for marketing approval of a new drug |
| NIST | National Institute of Standards and Technology | U.S. organization setting standards |
| NMPA | National Medical Products Administration | Regulatory authority responsible for pharmaceuticals and medical devices in China |
| O&M | Operations and Maintenance | Activities related to the operation and upkeep of equipment |
| OECD | Organisation for Economic Co-operation and Development | International organization for economic co-operation |
| OOS | Out of Specification | Results outside of defined specifications |
| OOT | Out of Trend | Trends outside of expected variability |
| OQ | Operational Qualification | Documentation and verification process to ensure equipment operates according to specifications |
| OTC | Over-the-Counter | Medications available without a prescription |
| PAT | Process Analytical Technology | Use of real-time analytics in manufacturing processes |
| PDE | Permitted Daily Exposure | Maximum allowable amount of a residual substance in a pharmaceutical product |
| PDP | Product Development Plan | Document outlining the strategy for developing a pharmaceutical product |
| PFD | Process Flow Diagram | Diagram that illustrates the sequence of steps in a process |
| PIC/S | Pharmaceutical Inspection Co-operation Scheme | International cooperation for GMP inspections |
| PID | Proportional-Integral-Derivative | Control loop feedback mechanism used in process control systems |
| PLC | Programmable Logic Controller | Industrial digital computer used for control of manufacturing processes |
| PLM | Product Lifecycle Management | Management of a product from inception through disposal |
| PM | Preventive Maintenance | Maintenance activities performed to prevent equipment failure |
| PMA | Pre-market Approval | Approval required for marketing medical devices |
| PPE | Personal Protective Equipment | Equipment worn to minimize exposure to hazards |
| PPQ | Process Performance Qualification | Qualification to ensure a process consistently produces results meeting predefined criteria |
| PQ | Performance Qualification | Documentation and verification process to ensure equipment consistently produces results meeting predefined criteria |
| PQR | Product Quality Review | Review of product quality data |
| PQRI | Product Quality Research Institute | Consortium of organizations focused on improving product quality in the pharmaceutical industry |
| PV | Pharmacovigilance | Monitoring and assessing drug safety |
| QA | Quality Assurance | Ensuring products meet quality standards |
| QA/QC | Quality Assurance/Quality Control | Processes to ensure product quality and compliance |
| QAU | Quality Assurance Unit | Unit responsible for ensuring QA compliance |
| QBD | Quality by Design | Approach to product development emphasizing quality |
| QMS | Quality Management System | System for managing quality processes |
| QRM | Quality Risk Management | Management of risks to product quality |
| QSAR | Quantitative Structure-Activity Relationship | Relationship between chemical structure and activity |
| QTPP | Quality Target Product Profile | Profile defining quality characteristics of a product |
| R&D | Research and Development | Process of discovering, testing, and developing new products |
| RA | Regulatory Affairs | Ensuring compliance with regulations |
| REMS | Risk Evaluation and Mitigation Strategies | Strategies to manage risks associated with drugs |
| RMS | Reference Member State | Member state responsible for assessment of applications |
| ROI | Return on Investment | Measure of the profitability of an investment |
| RPN | Risk Priority Number | Numeric assessment of risk in FMEA |
| SAE | Serious Adverse Event | Adverse event resulting in death or hospitalization |
| SAR | Serious Adverse Reaction | Serious adverse reaction to a pharmaceutical |
| SOP | Standard Operating Procedure | Documented procedure for standard tasks |
| SPC | Statistical Process Control | Method of monitoring and controlling processes using statistical techniques |
| TGA | Therapeutic Goods Administration | Regulatory authority for therapeutic goods in Australia |
| TMF | Trial Master File | File containing essential documents for a trial |
| TP | Technical Package | Documentation package for a product or process |
| TPD | Therapeutic Products Directorate | Health Canada division responsible for regulating pharmaceuticals and medical devices |
| TQM | Total Quality Management | Management approach emphasizing quality and continuous improvement |
| URS | User Requirement Specification | Document specifying requirements of a system from a user’s perspective |
| USAN | United States Adopted Name | Official name assigned to a pharmaceutical substance for use in the U.S. |
| USP | United States Pharmacopeia | Standards for pharmaceuticals |
| V&V | Verification and Validation | Process of ensuring products meet requirements |
| WHO | World Health Organization | International public health organization |
| WIP | Work in Progress | Inventory that is in the process of being made |
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