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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Change Control

A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes (that)which might affect validated status. The intent is to determine the need for action which would ensure that the system is maintained in a validated state.

Clinical Trial Pharmacist

The pharmacist responsible for the acquisition, storage, preparation, management, and return of investigational drugs for clinical trials at the trial site, as designated by the head of the trial institution.

Clean Zone

A local spatial structure which is constructed and used to minimize entry, generation and retention of particles within that zone.

Capping

The first modification made to transcribed RNA and takes place co-transcriptionally in the nucleus as soon as the first 25–30 nucleotides are incorporated into the transcript.

Chickenpox

An illness caused by the varicella-zoster virus characterized by an itchy rash with small, fluid-filled blisters.

Clinical Practice Guideline (CPG)

Statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.

Capsid

The protein shell of a virus, enclosing its genetic material.

Chiral

Asymmetric in such a way that the structure and its mirror image are not superimposable.

Capsomere

The capsomere is a subunit of the capsid, an outer covering of protein that protects the genetic material of a virus. Capsomeres self-assemble to form the capsid.

Chromatography

A laboratory technique for the separation of a mixture into its components. Chemical mixture carried by a liquid or gas is separated into components as a result of differential distribution of the solutes as they flow around or over a stationary liquid or solid phase.

Capsule

A polysaccharide layer that lies outside the cell envelope of bacteria.

Cleaning Validation

A procedure of establishing documented evidence that cleaning processes for manufacturing equipment prevents product contamination.

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.

Clinical Endpoint (or Outcome)

Outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials.