Coalition for Epidemic Preparedness Innovations (CEPI)
A global partnership working to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats.
Cross Sectional Study (CSS)
A type of observational study that analyzes data from a population, or a representative subset, at a specific point in time.
Critical Quality Attributes (CQAs)
A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
Critical Steps
Process stages affecting product quality. An important action that is necessary to achieve a desired result.
Crohn’s Disease
A chronic medical condition characterized by inflammation of the bowel. Symptoms include abdominal pain, diarrhea, fever, loss of appetite, and weight loss. The cause of Crohn’s disease is not yet known, but genetic, dietary, and infectious factors may play a part.
Controlled Before and After Study
A type of non-randomized study in which outcomes are measured before and after a treatment, both in a group that receives the treatment and in another comparison group.
Cross Contamination
Contamination of a starting material, intermediate, or final product during production with another starting material or product.
Convalescent plasma
Blood plasma that is obtained from an individual who has recovered from an infectious disease and contains antibodies against the infectious agent of the disease and may be administered by intravenous transfusion to prevent or treat infection in other individuals.
Cross Tolerance
A phenomenon that occurs when tolerance to the effects of a certain drug produces tolerance to another drug.
Convention On Biological Diversity (CBD)
The international legal instrument for “the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources” that has been ratified by 196 nations.
Crossover Design
A type of study design in which participants are randomly assigned to treatment arm, but then “crossover” to another treatment arm during the course of the trial.
Convulsion
The sudden onset of a jerking (localized or generalized) or staring spell. Seizures following a vaccination can be caused by fever. Also known as convulsions.
Crossover Trial (or Study) Design
A type of clinical trial in which all participants receive the same two or more treatments, but the order in which they receive them depends on the group to which they are randomly assigned.
Covariate
A continuous variable that is not part of the main experimental manipulation but has an effect on the dependent variable.
Coordinating Committee
A committee organized by the sponsor to coordinate the conduct of a multi-center clinical trial.
Crumbling
To break into small pieces.
Coordinating Investigator
An individual responsible for coordinating opinions among investigators participating in multi-center clinical trials among various trial site investigators.
Crystallize
To change into a solid form that is made up of crystals.
Corrective Action
A particular action aimed at removing the cause of product failures and nonconformities in an effort to prevent their future recurrence.
Culture
Cells, tissues, organs, or organisms grown for scientific purposes, or the activity of breeding and keeping particular living things in order to get the substances they produce.
COVID-19
A disease caused by the SARS-CoV-2 virus. Symptoms can include fever or chills, cough, shortness of breath, difficulty breathing, fatigue, new loss of taste or smell, and more.
Current Good Manufacturing Practice (cGMP)
Regulations ensured by FDA for drugs that contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
Cowpox
Cowpox is an infectious disease caused by the cowpox virus (CPXV). Cowpox is similar to, but much milder than, the highly contagious and often deadly smallpox disease. Its close resemblance to the mild form of smallpox and the observation that dairy farmers were immune to smallpox inspired the modern smallpox vaccine, created and administered by English physician Edward Jenner.
Customs Clearance
The process of declaring goods to customs authorities when entering or leaving a country.
Critical Area
A space designed to maintain the sterility of sterile substances.
Cytokine
Proteins in the body that act as messengers between immune system cells.
Critical operation
An operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.
Cytotoxicity
The property of being toxic to a cell.
Critical Path Initiative (CPI)
FDA’s national strategy for transforming the way FDA-regulated medical products are developed, evaluated, and manufactured.
Critical Process Parameters (CPP)
Process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.
Confidence interval
The mean which displays the probability that a parameter will fall between a pair of values around the mean.
Cold Chain system
A temperature-controlled supply chain comprising refrigerated production, storage and distribution facilities supported by equipment that can constantly maintain the required low-temperature range.
Compulsory License
A permit or authorization granted by government to an applicant for using a patented technique or product.
Control Strategy
A planned set of controls derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance and finished product materials and components; facility and equipment operating conditions; in-process controls; finished product specifications; and the associated methods and frequency of monitoring and control.
Confirmatory Trial
Phase III clinical trials to confirm the therapeutic intervention’s previously identified effects.
Colony forming unit (CFU)
A unit which estimates the number of microbial cells (bacteria, fungi, viruses etc.) in a sample that are viable, able to multiply via binary fission under the controlled conditions.
Concurrent Validation
A type of validation that occurs during the routine production of the product.
Control testing
Assessment of the quality and specifications of each batch of a medicinal product carried out by an independent laboratory.
Conjugate vaccine
A type of bacterial vaccine in which two compounds (usually a protein and polysaccharide) are joined to each other to increase the vaccine’s effectiveness.
Combination vaccine
A vaccine that is designed to protect against two or more diseases or against one disease caused by different strains or serotypes of the same organism. Therefore, combined vaccines contain two or more antigens that are either combined by the manufacturer or mixed immediately before administration. Such vaccines are in common use because they allow simultaneous administration of multiple antigens resulting in fewer injections and visits to the clinic.
Conductivity
The ability to move heat or electricity from one place to another.
Controlled Area
Areas constructed and operated to control the risk of potential contaminant ingress and unforeseen exposure to organisms.
Conjugation
The temporary union of two bacteria or unicellular organisms for the exchange of genetic material.
Commission
An instruction, command, or duty given to a person or group of people.
Confidential Disclosure Agreement (CDA)
A contract where parties agree to keep sensitive information shared between them confidential.
Conjunctivitis
Inflammation of the mucous membranes surrounding the eye causing the area to become red and irritated. The membranes may be irritated because of exposure to heat, cold, or chemicals. This condition is also caused by viruses, bacteria, or allergies.
Communicable
That which can be transmitted from one person or animal to another, infectious.
Confidentiality
Preserving authorized restrictions on access and disclosure.
Containment
Act of keeping something under control so that it cannot spread in a harmful way.
Community immunity
A situation in which a sufficient proportion of a population is immune to an infectious disease (through vaccination and/or prior illness) to make its spread from person to person unlikely. Even individuals not vaccinated (such as newborns and those with chronic illnesses) are offered some protection because the disease has little opportunity to spread within the community. Also known as herd immunity.
Configuration
Documentation of the physical and functional properties of a system, such as software, hardware, and operating systems.
Content Uniformity
A pharmaceutical analysis parameter for the quality control of capsules or tablets. Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet.
Comparability
The comparability of statistical data means that the methodology for assessing of indicators allows for reliable comparisons in time and space
Consignment
The quantity of a pharmaceutical or pharmaceuticals, made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
Comparative Dissolution
A test demonstrating the similarity of in vitro release profiles between two formulations with the same active ingredient and administered by the same route.
Contamination
The undesired introduction of impurities of a physical, chemical or microbiological nature, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.
Comparative Study
A method for evaluating the efficacy of a drug in clinical trials by comparing the investigational product with a control drug to assess their performance.
Content Validity
A type of criterion validity that demonstrates how well a measure covers the construct it is meant to represent.
Complementary DNA (cDNA)
Synthetic DNA in which the sequence of bases is complementary to that of a given example of DNA.
Contract
Legally binding agreement that governs the conduct of a particular trial or study and sets forth the obligations of each party to the agreement.
Completion
Termination of participation in a clinical trial by a subject after all requirements outlined in the protocol are completed.
Contract Manufacturing Organizations (CMO)
A company that manufactures products on behalf of other companies.
Clinical Trial/Study Report
Document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study.
Compliance
Conducting a clinical trial in accordance with the clinical trial protocol, Good Clinical Practice (GCP) guidelines, and other relevant regulations.
Contract Research Organization (CRO)
Company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
Code of Federal Regulations (CFR)
The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Compliance Program (CP)
Compliance system that companies operate to comply with laws and regulations on fair trade.
Contraindication
A condition (a situation or factor) that serves as a reason not to take a certain medical treatment due to the harm that it would cause the patient.
Colony
The bacterial colony is a cluster of identical cells (clones). These colonies often form and grow on the surface of (or within) a solid medium, usually derived from a single parent cell.
Coefficient
(Chemistry) A number placed in front of a chemical symbol or formula that shows how many atoms or molecules of the substance are involved in the reaction.
Composition
In chemistry, it is the arrangement, type, and ratio of atoms in molecules of chemical substances.
Control Drug
A drug or other substance that is tightly controlled by the government because it may be abused or cause addiction.
Common Technical Document (CTD)
Set of specifications for an application for the registration of medicines.
COGs (Cost Of Goods sold)
The direct costs of producing the goods sold by a company.
Compounding
A process of combining bulk active pharmaceutical ingredients (APIs) with other bulk APIs and/or one or more excipients to produce finished pharmaceutical products.
Control Event Rate (CER)
The proportion of participants in the control group that have the outcome.
Comparative Crumbling
A test comparing the rate of drug dissolution to establish pharmaceutical equivalence.
Cohort Study
Particular form of longitudinal study that samples a cohort performing a cross-section at intervals through time.
Compressed Tablet
A pharmaceutical tablet formed by subjecting dry granular powders to sufficient pressure to make the particles cohere.
Control Number
A number assigned for the management of materials that cannot be assigned a manufacturing unit.
Carry-over Effect
Any effect from a previous experimental intervention that carries over onto a period after the experiment has been terminated and subjects are no longer experiencing the intervention.
Cleanroom
An engineered space that maintains a very low concentration of airborne particulates. It is well isolated, well controlled from contamination, and actively cleansed.
Case Report Form (CRF)
Research-specific document that collects all the relevant data for a given protocol.
Clinical Endpoint (or Outcome)
Outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials.
Catalytic Reaction
The reaction which involves a catalyst in their system, which increases rate of a chemical reaction.
Clinical Importance / Clinical Significance
Practical importance of a treatment effect—whether it has a real genuine, palpable, noticeable effect on health or daily life.
Causal association
A relation in which the presence or absence of a variable (e.g. smoking) is responsible for an increase or decrease in another variable (e.g. cancer). A change in exposure leads to a change in the outcome of interest.
Clinical Investigator’s Brochure
Collection of clinical and non-clinical data about the investigational products that are the focus of the study.
Cell Bank
A collection of appropriate containers whose contents are of uniform composition and stored under defined conditions. Each container represents an aliquot of a single pool of cells.
Clinical Pharmacology
Discipline that teaches, does research, frames policy, gives information and advice about the actions and proper uses of medicines in humans and implements that knowledge in clinical practice.
Cell Culture
The process by which cells that are no longer organized into tissues are grown in vitro under defined and controlled conditions. Cell cultures are operated and processed under axenic conditions to ensure a pure culture absent of microbial contamination.
Clinical Research Associates (CRA)
A health-care professional who performs many activities related to medical research, particularly clinical trials.
Cell line
Cultures of cells that can be propagated repeatedly and sometimes indefinitely.
Clinical Research Coordinator (CRC)
An individual who oversees most of the administrative responsibilities related to the clinical trial, serving as a liaison between the investigator and the sponsor, and reviewing data before monitor visits.
Center for Biologics Evaluation and Research (CBER)
Is the center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
Clinical Trial / Clinical Study
Research studies that test a medical, surgical, or behavioral intervention in people.
Calibration
The set operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring, recording, and controlling, or the values represented by a material measure, and the corresponding known values of reference standard. Limits for acceptance of the results of measuring should be established.
Certificate Of Analysis (CoA)
A document that communicates the results of a scientific test done on a product such as food or drugs.
Clinical Trial Material
Pharmaceuticals that are in a finished form suitable for administration to clinical trial participants but not intended for commercial sale.
CAPA -Corrective Action Preventive Action
A quality system defined by 21 CFR Part 820.100; the policies, procedures, and support systems that enable a firm to assure that exceptions are followed up with appropriate actions to correct a defined situation, and with continuous improvement tasks to prevent recurrence and eliminate the cause of potential nonconforming product and other quality problems.