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PDA Glossary

PDA Glossary of Pharmaceutical and Biotechnology Terminology

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

Browse Terms by Title


Browse Terms by TR #

  • Decision Maker(s)

    Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)

  • Drug Shortage Prevention & Response Plan

    A document that provides a structured action plan to proactively prevent drug shortages and also respond to a shortage in the event that one occurs. (TR68)

  • Drug Shortage Risk Register

    A single source of information on risks that can result in drug shortages, associated risk levels, risk control actions with owners, status, due dates and residual risk after appropriate risk control actions have been taken. (TR68)

  • Economically Motivated Adulteration

    The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production (i.e., for economic gain). (TR54-3)

  • Enabler

    A tool or process which provides the means to achieve an objective (ICH Q10). (TR54)

  • Extemporaneous Preparation (EP)

    A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)

  • Extended Producer Responsibility (EPR)

    Refers to a legislative requirement that packaging manufacturers “take back” their packaging, or otherwise ensure (through a tax) that it is collected and properly disposed of. (TR46)

  • Facilitator

    Independent QRM expert who facilitates risk assessment; guides documentation, risk control, and risk review; and helps present risk assessment results and risk control proposals. (TR54-2) (TR54-5)

  • Heat-Treated Wood Pallets

    Two types of methods to include kiln drying versus steam heat. (TR55)

  • Henry’s Law Constant

    Henry’s law can be put into mathematical terms (at constant temperature) as p=kH x c, where p is the partial pressure of the solute, i.e.. TBA in the gas above the solution, c is the concentration of the solute and kH is a constant with the dimensions of pressure divided by concentration. The constant, known as Henry’s law constant, depends on the solute, the solvent and the temperature. (TR55)

  • Incoming Inspection

    A preventative program where parts or products are subjected to evaluation upon receipt.(TR43)

    A program where, upon receipt, parts or products are subjected to measuring, examining, testing, or gauging one or more characteristics of a product or service, and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.(TR 76)

  • Incoterms

    International commerce terms. These are a series of international sales terms, published by the International Chamber of Commerce (ICC), and widely used in international commercial transactions. (TR58)

  • ISTA: International Safe Transit Association

    World-wide organization that supports its membership in designing and developing effective pre-shipment packaging performance standards, guides, and best practices for product distribution. (TR39)

  • Knowledge Management

    Systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components (ICH Q10). (TR54) (TR68) (TR54-5)

  • Life Supporting or Life Sustaining Drug

    Life supporting or life sustaining is used to describe a product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function that is important to the continuation of human life. (TR68)

  • Logistics Service Providers (ISP or 3PIs)

    Freight forwarders and brokers that assist in moving the product, but may not physically touch the product. (TR52)

  • Manufacturing

    The production, packing, testing, storage, release and distribution of drugs or medical devices for use in humans or animals where the manufacturing is indented to produce doses, typically in significant numbers, for an undefined population of future patients or clinical trial subjects. (TR63)

    All operations including purchasing and receipt of materials to production, packaging, labelling, quality control, release, storage, distribution of components and the related controls. (TR 76)

  • Market Action

    Voluntary withdrawal, recall or notification to patients, consumers or physicians of marketed pharmaceutical or consumer healthcare products for compliance or safety reasons. (TR55)

  • Market Package

    The package presentation intended for the end user (e.g., bottle + cap liner + screw cap + label + dose cup + carton; may contain multiple units of product), but not including packaging used solely for transportation (e.g., corrugated boxes or insulated containers). (TR39)

  • Meaningful Disruption

    A meaningful disruption is a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product. A meaningful disruption is not an interruption in manufacturing due to matters such as routine maintenance and does not include insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. (TR68)

  • Medically Necessary Drug

    Any drug product used to diagnose, treat, or prevent a serious disease or medical condition for which no other drug is judged to be an appropriate substitute or there is an inadequate supply of an acceptable alternative as determined by the relevant health authority. (TR68)

  • Medicinal Product

    Any product intended for the diagnosis, treatment, or prevention of disease. (TR39)

  • Microprocessor

    One of the five major components of a TCU, the unit interfaces with temperature sensors in the discharge and return air and adjusts the output rate of active cooling or heating to achieve the setpoint temperature. (TR64)

  • Moisture Content of Wood

    The moisture content of wood is calculated by the following formula: Moisture content = (Mg-Mod)/Mod. Where Mg is the green mass of the wood and Mod is its oven-dry mass (the attainment of constant mass generally after drying in an oven set at 103 ± 2 °C for 24h). The equation can also be expressed as a fraction of the mass of the water and the mass of the oven-dry wood rather than a percentage. For example, 0.59 kg/kg (oven-dry basis) expresses the same moisture content as 59% (oven-dry basis). (TR55)

  • Opportunity Costs

    This is defined as the value of the next-best choice available when choosing between several mutually exclusive choices (e.g., the decision to expand a facility may result in losing the opportunity to invest the maintenance funds in the financial markets). Opportunity costs are often excluded from estimates of fixed operation costs because they can be difficult for comparative analyses in the overall decision process. (TR66)

  • Organohalogens

    The major organohalogens or organic compounds containing chlorine, bromine or iodine of interest are halophenols and haloanisoles, especially 2,4,6 tricholorophenol (TCP), 2, 4, 6 tribromophenols (TBPs), 2, 4, 6 trichloroanisole (TCA), and 2, 4, 6 tribromoanisole (TBA). (TR55)

  • Over-the-Counter (OTC) Drug Products

    Drug products sold in drug stores directly to customers without a physician’s prescription. (TR67)

  • Packout

    Insulated container that uses refrigerant to keep a product within a specified temperature and time range; see passive system. (TR58)

  • Pallets

    Pallets are flat transportation structures that are used in the efficient shipping, warehousing and in-plant distribution of goods. A loaded pallet may be moved using a fork lift or pallet jack. They are usually 48 x 40 inches in dimension. They are most commonly constructed of wood but may be plastic, metal or even paper. (TR55)

  • Planning Bill of Materials (BOM)

    A complete list of the raw material (chemicals, media, powders, resin, etc.) and consumables/components (filters, bags, tubing, containers, etc.) that are required to manufacture the product. (TR65)

  • Plant Utilities

    Utilities include pharmaceutical-grade water systems, compressed gases, pharmaceutical-grade air systems, heating, ventilation and air conditioning systems, and space pressurization. (TR67)

  • Platform Manufacturing

    Development of a production strategy for a new drug starting from manufacturing processes similar to those used to manufacture other drugs of the same type (the production for which there already exists considerable experience). (TR60)

  • Platform-Based Method

    Existing method based on the same basic principles and steps as a new method that is required and defined in the design/strategy phase; applies to multiple sample types and requires minimal changes or refinements based on specific product requirements. (TR57-2)

  • Potential Drug Shortage

    A potential drug shortage is described as the occurrence of internal or external situations (single or in a combination of both), which could result in an interruption of supplies of a medicinal product, if not properly addressed and controlled. (TR68)

  • Practice of Pharmacy

    The interpretation, evaluation and implementation of medical orders which may include the administering, preparing, compounding, preserving, and/or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions, clinical protocol or other legal authority. Note: Many localities have broader definitions describing very specific activities and responsibilities that further defines the practice of pharmacy. (TR63)

  • Preparation Site

    The location where extemporaneous preparations of Clinical Trial Materials (CTM) are made. (TR63)

  • Process

    A series of operations and/or actions used to produce a desired result. (TR38)

  • Retailer

    A “retailer” buys goods or products in large quantities from manufacturers or importers, either directly or through a wholesaler, and then sells smaller quantities to the end-user. Examples of retailers that sell pharmaceutical products are pharmacies and hospitals. (TR58)

  • Reverse Logistics

    The process of planning, implementing and controlling the efficient, cost-effective flow of raw materials, in-process inventory, finished goods and related information from the point of consumption to the point of origin for the purpose of recapturing value or proper disposal. (TR46)

  • RKN container

    The three letter code refers to the type of ULD. Position 1 letter identifies ULD category (certification, ULD type, thermal units). Position 2 letter identifies standard base dimensions. Position 3 letter identifies contour, forklift holes, and other miscellaneous information. Here R is standing for Thermal Certified Aircraft Container. K refers to the dimensions of the container (1,534 x 1,562 mm (60.4 x 61.5 in)). The third letter describes the container’s contour and fork lift capability. Refer to the IATA “ULD Technical Manual” for complete information. (TR58)

  • Secondary Packaging Component

    A component that is not nor will not be in direct contact with the drug product (e.g., vial seals, overwraps, container labels). The purpose of secondary packaging is to identify, protect, market, and communicate information about the product. Examples of secondary packaging include labels, cartons/folding boxes, and leaflets. (TR39)

  • Shift

    Scheduled periods of work or production, usually less than 12 hours in length, staffed by alternating groups of workers. (TR22) (TR62)

  • Shipper

    An individual or company who tenders products for transportation. (TR39)

    The person or organization responsible for arranging transportation of goods with carriers and/or freight forwarders. (TR58)

  • Shipping

    The transit of any material by land, sea, or air from one site to another. This may include intraplant movements. (TR39)

  • Shipping Container

    A standardized reusable metal box used for safe, efficient and secure storage and movement of materials and products within a global containerized intermodal freight transport system. Intermodal implies that the container can be moved from one mode of transport to another without unloading and reloading. They are the main type of equipment used in intermodal transport, particularly when one of the modes of transportation is by ship. They can also be referred to as ISO containers because the dimensions have been defined by ISO. Other types of transportation containers can include truck trailers. (TR55)

  • Shipping Documentation

    Documents that have been written for a particular shipment; for example, CMR (Convention Relative au Contract de Transport International de Marchandises par la Route), BOL (Bill of Lading) and/or AWB (airway bill). (TR58)

  • Shipping Lane

    An established route of transportation between a specific point of origin to a specific destination. More defined routes will consistently use the same combination and types of transportation vehicles and transfer procedures, but this may not be observed through all shipping lanes throughout the last mile. (TR46)

    Lane described by origin, transportation node(s) and destination in combination with the used transport mode(s) (truck, aircraft, etc.). (TR58)

  • Significant Body of Information

    A significant body of information on the stability of the drug product is likely to exist after 5 years of commercial experience for new molecular entities, or 3 years of commercial experience for new dosage forms (TR38)

  • Stakeholder(s)

    Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)

    Any individual, group, or organization that can affect, be affected by, or perceive itself to be af­fected by a risk. Decision makers might also be stakeholders. (TR54-5)

  • Sub-Contractor

    An individual or company hired by the transport service provider to perform the actual shipment. The shipper and the sub-contractor do not necessarily have a contractual agreement. (TR39)

  • Transport Service Agreement

    A contractual agreement that describes the legal, logistical, technical and quality terms or contractual arrangements between shippers and transport services providers. Different names might be used for this type of agreement in different companies. (TR39)

  • Transport Service Provider

    Contracting party who mediates or executes the transportation of medicinal products on behalf of the shipper. (TR39)

  • Transportation Service Providers (TSP)

    Companies that physically transport the product. (TR52)

  • Transportation Study

    Study performed to generate data to evaluate the effect of temperature variation on the product during transportation on product quality. Other test, such as vibration, pressure, and drop tests, may be considered. (TR39)

  • Verification Accredited Wholesale Distributors (VAWD)

    An accreditation governed by the U.S. National Association of Boards of Pharmacy for pharmaceutical wholesale distribution facilities indicating that they are in compliance with state and federal laws. (TR52)