21 CFR part 11
- Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
- Being auxiliary or supplementary (use of a drug as ancillary to surgical treatment or ancillary services).
Back-up power station
- An emergency power plant that generates and distributes electricity.
- A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Since the late 1990s biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized medicine.
- BioSample relates to a discrete physical object that is composed of biological material and has, or will have, assay data associated with it. These include blood samples, cell cultures or individual organisms. However, a BioSample can also be an environmental sample (for instance, for meta-genomic analysis), a hybrid between two species, or a parasite culture.
- Finding an alternative with the most cost effective or highest achievable performance under the given constraints, by maximizing desired factors and minimizing undesired ones.
- Central Labs support drug, medical device and diagnostics trials with extensive global reach, a wide array of clinical testing services and dedicated assay development to get quality lab data on time.
Сertified destruction facility
- Public or privately owned (commercial) repositories for proper and permanent containment of solid and semi-solid waste material.
- A vendor, also known as a supplier, is an individual or company that sells goods or services to someone else in the economic production chain.
Сlinical project management
- A clinical trial management system (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
Сlinical study materials
- A term of art referring to a set of supplies provided to an investigator by the trial sponsor.
- A process of providing the necessary medications and materials to investigational sites for the purposes of conducting clinical studies.
- Clinical trials can be defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Clinical trials are often characterized in phases:
PHASE 0: Officially named at the FDA as an exploratory investigational new drug study and also known as a “microdosing” study. Exploratory trials to establish whether the agent behaves in humans as was expected from preclinical animal studies, to gather preliminary data on pharmacodynamics or pharmacokinetics, to select promising lead candidates, or to explore biodistribution characteristics. Phase 0 studies do not replace formal Phase I drug safety testing and do not offer any possibility of patient benefit. Intended to speed drug development as part of the FDA Critical Path Initiative by quickly weeding out ineffective drugs early in the development process. (No therapeutic or diagnostic intent.)
PHASE I: Initial studies to determine the metabolism and pharmacologic actions of the agent in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
PHASE I/II (Device – Pilot): Some trials combine Phase I and Phase II, and test both efficacy and toxicity (safety, dosage levels, and response to new treatment).
PHASE II: Controlled clinical studies conducted to evaluate the effectiveness of the agent for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
PHASE II/III: Some trials combine Phase II and Phase III, and test for both efficacy and overall benefit-risk relationship. The new treatment is compared to a standard treatment regimen.
PHASE III (Device – Pivotal): Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the agent/test article has been obtained and are intended to gather additional information to evaluate the overall benefit-risk relationship and provide an adequate basis for physician labeling. Compares new agent/test article against commonly used agents/test articles.
PHASE IV: Post-marketing studies to delineate additional information including the agent’s risks, benefits, comparative effectiveness, and optimal use. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
Сlinical trial audit
- A sponsor's audit of a clinical trial is an important element of GCP and is independent of and separate from monitoring and quality control functions. Its purpose is to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
Сlinical trial documentation
- The essential documents for clinical trials are the following: Investigator's Brochure, Clinical Study Protocol, Subject Information and Informed Consent Form,Clinical Study Reports,Case Report Form (CRF).
- COA (Certificate Of Authenticity) - An accompanying document which states that it is an original package from the manufacturer. It generally includes a seal with a difficult-to-copy emblem such as a holographic image.
- Certificate of Conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.
Сold chain distribution
- A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of products such as fresh agricultural produce, seafood, frozen food, photographic film, chemicals and pharmaceutical drugs.
- A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range.
- Any medication against which the test drug is being compared. The term 'comparator' usually implies another active drug preparation (placebo being used to describe inactive, control medication).
Сoncomitant therapy drugs
- Concomitant drugs are two or more drugs used or given at or almost at the same time (one after the other, on the same day, etc.). The term has two contextual uses: as used in medicine or as used in drug abuse.
- Controlled drug is any drug or therapeutic agent–commonly understood to include narcotics, with a potential for abuse or addiction, which is held under strict governmental control, as delineated by the Comprehensive Drug Abuse Prevention & Control Act passed in 1970.
- A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
- A statement showing goods being imported on which duty will have to be paid.
- A document that is typically signed by the receiver of a shipment to indicate that they have in fact received the item being shipped and have taken possession of it. Most businesses that transport valuable items via mail or parcel post will require the completion of a signed delivery receipt to make sure that the goods were actually received by the intended recipient.
- Inducement paid by a vessel operator to a shipper, consignee, or chartrer for completing the loading/offloading operations in less than the allotted time.
- The act or process of getting rid of something.
- A distribution center for a set of products is a warehouse or other specialized building, often with refrigeration or air conditioning, which is stocked with products (goods) to be redistributed to retailers, to wholesalers, or directly to consumers.
- Patients' withdrawal from participation in clinical trials.
- The act or process of damaging something so badly that it no longer exists or cannot be repaired.
- Distribution in pharmacology is a branch of pharmacokinetics which describes the reversible transfer of drug from one location to another within the body. Once a drug enters into systemic circulation by absorption or direct administration, it must be distributed into interstitial and intracellular fluids.
- The act of keeping back or setting aside for some future occasion.
Electronic Case Report Forms (eCRFs)
- A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site.
- Expiration date: The date for a drug estimated for its shelf life with proper storage in sealed containers away from harmful and variable factors like heat and humidity. The expiration date of a medicine is based on data, called accelerated stability data, from testing by the manufacturer, that show the product will be good for a particular period of time.
- The process of supply management according to the expiry dates of the product for proper usage of available stock with the limited shelf life. FEFO (first expired first-out) is a wide-used technique of expiry management.
- Additional labelling of medications alongside with the manufacturer's labeling for prolongation of the shelf-life of the product according to the manufactures instructions.
- Forecasting is the process of making predictions of the future based on past and present data and analysis of trends. A commonplace example might be estimation of some variable of interest at some specified future date using algorithms and different methods.
- Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
- Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible (as per Article 1.2 of 2001/20/EC ).
Government sourcing programs
- Strategic sourcing increases an organization’s buying power to maximize the leverage it has with suppliers for the purposes of reducing cost, enhancing quality and improving supplier diversity. Governments accomplish this by aggregating the demand from all agencies and reducing the number of suppliers, oftentimes to a single supplier.
Highly active substances
- Any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affects the structure or any function of the body of man or animals.
- A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.
- Import licensing can be defined as administrative procedures requiring the submission of an application or other documentation (other than those required for customs purposes) to the relevant administrative body as a prior condition for importation of goods.
International Air Transport
- Legislation that analyzes goods that may be imported or exported. Regulations set out the criteria making these determinations.
International Air Transport Association Association (IATA)
- is a trade association of the world's airlines. These 250 airlines, primarily major carriers, carry approximately 84% of total Available Seat Kilometers air traffic. IATA supports airline activity and helps formulate industry policy and standards.
International Conference on Harmonization Good Clinical Practice (ICH GCP)
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.
- Inventory management is a science primarily about specifying the shape and percentage of stocked goods. It is required at different locations within a facility or within many locations of a supply network to precede the regular and planned course of production and stock of materials.
- A drug available only for experimental purposes because its safety and effectiveness have not been proven.
Investigational Product (IP)
- An investigational product is a pharmaceutical form of an active ingredient or placebo, being tested or used as a reference in a Clinical Study.
- The location in which a clinical trial takes place e.g., a hospital department or a GCP surgery. For Human Volunteer Studies, the centre is a specially designed and equipped research centre, which usually resembles a hospital ward.
- ISO 9001:2008 is an international standard related to quality management system, applicable to any organization from all types of business sectors and activities. ISO 9001:2008 is based on eight quality management principles (all fundamental to good business practice). When fully adopted, these principles can help improve your organizational performance:
Customer focus: organizations depends on their customers, and therefore need to shape activities around the fulfillment of market need
Leadership: is needed to provide unity of purpose and direction
Involvement of people: creates an environment where people become fully involved in achieving the organization's objectives
Process approach: to achieve organizational objectives, resources and activities need to be managed as processes, with an understanding of how the outputs of one process affects the inputs of another
System approach to management: the effectiveness and efficiency of the organization depends on a systemized approach to work activities
Continual improvement: adopting this as a part of everyday culture is a key objective for an organization
Fact based decision-making: effective decisions are based on the logical and intuitive analysis of data and factual information
Mutually beneficial supplier relationships: such relationships will enhance theability to create value.
- Kit means all components of a test that are packaged together.
Learning Management System (LMS)
- A learning management system (LMS) is a software application for the administration, documentation, tracking, reporting and delivery of electronic educational technology (also called e-learning) education courses or training programs.
Letter of exemption
- Tax Exempt means to be free from, or not subject to, taxation by regulators or government entities. A tax exempt entity can be excused from a single or multiple taxation laws. Governments are often trying to encourage investment when exempting taxation.
- A hub in which clinical supplies and materials are stored for local distribution to investigational sites.
- A company that provides management over the flow of goods and materials between points of origin to end-use destination. The provider will often handle shipping, inventory, warehousing, packaging and security functions for shipments.
- A lot number is an identification number assigned to a particular quantity or lot of material from a single manufacturer. Lot numbers can typically be found on the outside of packaging.
Managed Access Program (MAP)
- Managed Access Program (MAP) is an umbrella term used when defining an ethical solutions-based approach to provision of unapproved medicines for patients with unmet medical needs, typical of the following scenarios when drugs: Are still in clinical development and have yet to be approved.
- Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:
be of consistent high quality
be appropriate to their intended use
meet the requirements of the marketing authorisation (MA) or product specification
Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.
- A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).
Monitoring and control
- Monitor and Control Project Work is the process for monitoring and controlling the processes used to initiate, plan execute, and close the project to meet the perfomance objectives defined in the project management plan.
- Monitoring device - display produced by a device that takes signals and displays them on a television screen or a computer monitor.
- Multinational clinical trials are trials conducted in more than one country using a common protocol. They have become increasingly common and have many advantages, such as access to a large patient population and the potential to obtain a broadly generalizable conclusion.
- Any drug, synthetic or naturally occurring, with effects similar to those of opium and opium derivatives, including meperidine, fentanyl, and their derivatives.
One-stop shop services
- A one stop shop, one stop store or one stop source is a business or office where multiple services are offered; i.e., customers can get all they need in just one stop.
- Packaging is the technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells.
- Patient enrollment is the most time-consuming aspect of the clinical trial process. The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline.
- The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals for use as medications. Pharmaceutical companies may deal in generic or brand medications and medical devices.
- Items deemed necessary for the treatment of an illness or injury.
Project closure and archiving
- A project archive is the systematic storing of project documents and artefacts (like project charter, project models, lessons learned documents, working papers). The project archive is important to administrative closure. When you have historical project documents at you disposal, this will provide valuable information for planning future projects, for on-going product support, for maintaining the project, and for public project disclosure requests.
- The execution/implementation phase ensures that the project management plan’s deliverables are executed accordingly. This phase involves proper allocation, co-ordination and management of human resources and any other resources such as material and budgets. The output of this phase is the project deliverables.
- The Project Initiation Phase is the 1st phase in the Project Management Life Cycle, as it involves starting up a new project. A new project can be started by defining its objectives, scope, purpose and deliverables to be produced.
Project Management Book of Knowledge (PMBok)
- A Guide to the Project Management Body of Knowledge (PMBOK Guide) is a book which presents a set of standard terminology and guidelines (a body of knowledge) for project management. The Fifth Edition (2013) is the document resulting from work overseen by the Project Management Institute (PMI). Earlier versions were recognized as standards by the American National Standards Institute (ANSI) which assigns standards in the United States (ANSI/PMI 99-001-2008) and the Institute of Electrical and Electronics Engineers (IEEE 1490-2011).
Project Management Institute (PMI)
- The Project Management Institute (PMI) is a US not-for-profit professional organization for project management. The PMI provides services including the development of standards, research, education, publication, networking-opportunities in local chapters, hosting conferences and training seminars, and providing accreditation in project management.
- A project manager is the person responsible for leading a project from its inception to execution. This includes planning, execution and managing the people, resources and scope of the project. Project managers must have the discipline to create clear and attainable objectives and to see them through to successful completion. The project manager has full responsibility and authority to complete the assigned project.
- Systematic sequencing and scheduling of the tasks comprising a project. Also called work planning.
Proof of Delivery (POD)
- Receipt signed by a consignee or recipient, confirming delivery of a shipment in good order and condition.
- Any medication capable of affecting the mind, emotions, and behavior. Some medications such as lithium, which may be used to treat depression, are psychotropic. Also called a psychodynamic medication.
Purchase Order (PO)
- A purchase order (PO) is a commercial document and first official offer issued by a buyer to a seller, indicating types, quantities, and agreed prices for products or services.
- Quality assurance (QA) is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention in quality assurance differs subtly from defect detection and rejection in quality control, and has been referred to as a shift left as it focuses on quality earlier in the process.
Quality Management System (QMS)
- A structure or framework for the implementation of quality management processes. In life science and other regulated industries, organizations must have their own QMS definition based on the regulations and standards they comply with, as well as their business goals.
- A term for a lab manual which describes the scope, purpose, organisation and management of a particular laboratory and its quality control and assessment systems.
- A quality policy should express top management's commitment to the quality management system (QMS) and should allow managers to set quality objectives. It should be based on ISO’s quality management principles and should be compatible with your organization’s other policies and be consistent with its vision and mission. ISO's quality management principles ask you to focus on customers and interested parties, to provide leadership, to engage and involve people, to use a process approach, to encourage improvement, to use evidence to make decisions, and to manage corporate relationships.
- Investigative activities that a business chooses to conduct with the intention of making a discovery that can either lead to the development of new products or procedures, or to improvement of existing products or procedures. Research and development is one of the means by which business can experience future growth by developing new products or processes to improve and expand their operations.
- A rare disease, also referred to as an orphan disease, is any disease that affects a small percentage of the population. Most rare diseases are genetic, and thus are present throughout the person's entire life, even if symptoms do not immediately appear.
- An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
- Also called callback - a summons by a manufacturer or other agency for the return of goods or a product already shipped to market or sold to consumers but discovered to be defective, contaminated, unsafe, or the like.
- Patient recruitment includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Patient enrollment is the most time-consuming aspect of the clinical trial process. The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline. Improving patient recruitment rates offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As the number of patients needed for clinical trials rises – as safety and regulatory issues drive trends toward larger and longer trials – the demand for patient recruitment services grows.
- The act of bringing or sending something back to a previous place, condition, or owner.
- Risk analysis is the process of defining and analyzing the dangers to individuals, businesses and government agencies posed by potential natural and human-caused adverse events.
- Software as a Service (SaaS) is a software distribution model in which applications are hosted by a vendor or service provider and made available to customers over a network, typically the Internet.
- A type of product label. The secondary label is generally placed in a less prominent position either beneath the primary label or on the back or side of a product. The secondary label contains information about the product such as its ingredients and nutritional values, health and safety warnings, instructions for use, manufacturer or supplier details, contact information, or detailed tracking and product information in a barcode format. The secondary label should provide a potential customer with more detailed information about the product they are considering purchasing.
- Shelf life is the length of time that a commodity may be stored without becoming unfit for use, consumption, or sale.
- The movement of medications from the source through a distribution channel, right up to the investigational sites.
- Standard operating procedures (SOPs) are written instructions intended to document how to perform a routine activity. The primary reason many companies rely on SOPs is to help ensure consistency and quality in their products. SOPs are also useful tools to operationalize and communicate important corporate policies, government regulations, and best practices.
- A form marketing in which a corporation pays for all of some of the costs associated with a project or program in exchange for recognition.
- A planning tool that helps management in its attempts to cope with the uncertainty of the future, relying mainly on data from the past and present and analysis of trends.
Study supply planning
- Supply planning involves activities in order to meet the future demand in best possible manner. It’s a forward looking process that tries to meet supply with demand. It’s a component of Supply and Operations Planning (S&OP) process. It also takes cares of financial and business goals of the organization.
- A supply chain is the network of all the individuals, organizations, resources, activities and technology involved in the creation and sale of a product, from the delivery of source materials from the supplier to the manufacturer, through to its eventual delivery to the end user. The supply chain segment involved with getting the finished product from the manufacturer to the consumer is known as the distribution channel.
- A graph recording changes in temperature over given periods of time.
- A printed copy of a temperature curve.
- Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. A study design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.
- The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH. Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol, audit certificate, subject enrollment log.
Unrestricted pharmaceutical license
- A biologic license application (BLA), short for biological product license application, is defined by the U.S. Food and Drug Administration (FDA) as follows: Biological [medical] products are approved for marketing under the provisions of the Public Health Service (PHS) Act.
Warehouse Management System
- A warehouse management system (WMS) is a software application that supports the day-to-day operations in a warehouse. WMS programs enable centralized management of tasks such as tracking inventory levels and stock locations. WMS systems may be standalone applications or part of an Enterprise Resource Planning (ERP) system.
- A white paper is an article that states an organization's position or philosophy about a social, political, or other subject, or a not-too-detailed technical explanation of an architecture, framework, or product technology. Typically, a white paper explains the results, conclusions, or construction resulting from some organized committee or research collaboration or design and development effort.
- A wholesaler is an intermediary entity in the distribution channel that buys in bulk and sells to resellers rather than to consumers. In its simplest form, a distributor performs a similar role but often provides more complex services. Distributors and wholesalers often work together as channel partners.
- Work instructions present a sequence of steps to execute a task or activity. The format is typically text, but a visual depiction of the steps can also constitute work instructions. Additionally, hyperlinks are often included. A mix of text, hyperlinks, and pictures are also included in documenting the process steps.