Pharmacom Glossaries

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Compliance

510(k): Medical Device Premarket Notification

AANDA: Abbreviated Antibiotic Drug Application

Active Pharmaceutical Ingredient (API): Raw material of a pharmaceutical product which contains the actual substance which makes the drug do what it purports to do.

ADR: Adverse Drug Reaction

Adulterated: Condition in which a product is unfit to be sold as a result of contamination, mix-ups or errors, or from have been manufactured under conditions which were not in a state of control.

Adverse Findings: The number of establishment inspections classified "Official Action Indicated" or "Voluntary Action Indicated" and the number of samples analyzed and classified as violative.

ANADA: Abbreviated New Animal Drug Application

ANDA: Abbreviated New Drug Application; An ANDA is typically used by potential manufacturers of a generic copy of a previously approved drug.

ANPR: Advanced Notice of Proposed Rulemaking

Audit: Activity whereby someone (internal personnel, a consultant, or the FDA) checks a manufacturing plant and the processes that occur there for compliance with cGMP regulations.

Calibration: The process of periodically checking and adjusting measuring devices and instruments to ensure specified accuracy and precision that are traceable to national or international standards.

CBER: Center for Biologics Evaluation and Research; Branch of FDA which makes policy decisions concerning biologics.

CDER: Center for Drug Evaluation and Research; Branch of FDA which makes policy decisions concerning drugs.

CDRH: Center for Devices and Radiological Health; Branch of FDA which makes policy decisions concerning medical devices.

Certificate of Analysis: Documentation from a supplier guaranteeing the content and quality of raw materials or components.

CFR: Code of Federal Regulations; Government publication which contains all regulations. FDA regulations can all be found in 21 CFR.

CFSAN: Center for Food Safety and Applied Nutrition; Branch of FDA which makes policy decisions concerning food and cosmetics.

Change Control: Industry term that identifies the need to allow established procedures for any change in a component, ingredient, or processing step in the manufacture of any regulated product. This is done to avoid arbitrary changes that might affect the quality of the product.

Civil Money Penalty: A monetary penalty for a non-criminal action that is assessed by FDA or the courts for violations of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

Compliance Achievement: The observed repair, modification, or adjustment of a violative condition, or the repair, modification, adjustment, relabeling, or destruction of a violative product when either the product or condition does not comply with the Acts enforced by the agency.

Contamination: The presence of any substance in a product that makes it impure, unclean, or unfit for use. There are three types of contamination: microbial, particulate, and cross-contamination.

CSI: Consumer Safety Inspector

CSO: Consumer Safety Officer

CVM: Center for Veterinary Medicine; Branch of FDA which makes policy decisions concerning veterinary drugs and feeds.

Design Control: Procedures followed to ensure that the design of a device has been adequately tested and then correctly transferred into commercial production without change.

Design Qualification: Design qualification (DQ) defines the functional and operational specifications of the instrument and details the conscious decisions in the selection of the supplier ". DQ should ensure that instruments have all the necessary functions and performance criteria that will enable them to be successfully implemented for the intended application and to meet business requirements. Errors in DQ can have a tremendous technical and business impact, and therefore a sufficient amount of time and resources should be invested in the DQ phase. For example, setting wrong operational specifications can substantially increase the workload for OQ testing, and selecting a vendor with insufficient support capability can decrease instrument up-time with a negative business impact. While IQ, OQ and PQ are being performed in most regulated laboratories, DQ is a relatively new concept to many laboratories. It is rarely performed in those cases where the equipment is planned to be used not for a specific but for multiple applications.
DSMA: Division of Small Manufacturers Assistance; an arm of CDRH whose mission is to aid the small manufacturer in complying with the law and to clarify the requirements of medical device regulations.

Efficacy: Quality of a regulated product indicating that it actually does what it purports to do.

EIR: Establishment Inspection Report; This is the FDA investigator's notes of the inspection including all significant conversations with management or management representatives, with are filed with his/her District Office.
EQ: Equipment Qualification is the overall process of ensuring that an instrument is appropriate for its intended use. EQ is often broken down into

Errors: Mistakes made during the manufacturing process causing a product to be adulterated.

FDA: Food and Drug Administration; Agency of the Department of Health and Human Services which regulates the safety, purity, and effectiveness of food, drugs, medical devices, biologics, and cosmetics.

FDA Form 482: FDA written notice of inspection presented by the investigator at the beginning of an inspection.

FDA Form 483: A summary report of inspectional observations. It is a list of objectionable conditions or practices observed during the inspection, prepared by the FDA investigator and presented to the auditee at the conclusion of an inspection.

FD&C Act: Federal Food, Drug, and Cosmetic Act. This law gives FDA the authority to ensure that all products it regulates are safe, pure, and effective.

FDAMA: Food and Drug Administration Modernization Act

FOIA: Freedom of Information Act; Under this act, anyone can request to see certain government files which previously had not been released to the public.

FR: Federal Register; Daily government publication which details the actions of agencies including FDA. Proposals of new regulations, notices of final regulation changes, notices of advisory committee meetings, new approvals, and other FDA actions can be found in the Federal Register.

GCP: Good Clinical Practices

GLP: Good Laboratory Practices

GMP: Good Manufacturing Practice (regulation); GMP (also know as cGMP, meaning "current" Good Manufacturing Practice) is a set of regulations requiring that quality, safety, and effectiveness be built into foods, drugs, medical devices, and biological products. Its goal is consumer protection, and manufacturers must comply with them, as they carry the force of law.

GRAS: Generally recognized as safe; When using food ingredients considered GRAS, manufacturers need not prove to FDA that they are safe.

HACCP: Hazard Analysis Critical Control Point; Inspection technique currently used in the fish industry. It is being considered as a model for other types of food inspections.

HEW: Department of Health, Education and Welfare. This was the department, the former home of FDA, was changed to become the Department of Health and Human Services.

HHS: Department of Health and Human Services; The head of this department is a member of the President's cabinet. FDA is an agency of this department.

IDE: Investigational Device Exemption.

Inactive Ingredient: Raw material of a pharmaceutical product which does not have any impact on the efficacy of the product.

INADA: Investigational New Animal Drug Application.

IND: Investigational New Drug (application); This is required when a sponsor wants to study a new drug in human volunteers.

Indictment: A formal accusation by a grand jury that sets forth charges against a defendant and states when the alleged crime occurred. An indictment is not a finding of guilt. Guilt can only be determined by a judge or jury after a trial.

Industry Surveillance: The total number of establishment inspections, sample collections, field examinations and wharf examinations conducted by FDA personnel.

Injunction: A civil action taken against an individual or company to stop production or distribution of a violative product.

Installation qualification: Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument.

ISO: Name generally applied to quality system standards published by the International Organization for Standardization. ISO certification is provided, on a fee basis, by third party assessors or registrars through an on-site, in-depth audit to determine that a company's quality system meets the requirements of the standard.

Manufacturing Material: Material (such as a cleaning agent, mold release agent, lubricating oil or other substance) used to facilitate the manufacturing process and which is not intended to be present in the finished product.

MDR: Medical Device Reporting (regulation); Regulatory requirement to report adverse consequences of medical device use.

Mixup: Act of confusing or switching different elements of production which results in adulteration of the product.

NCTR: National Center for Toxological Research; Branch of FDA concerned with research and testing.

NDA: New Drug Application; its submission is required for each new drug product.

NPRM: Notice of Proposed Rulemaking

ORA: Office of Regulatory Affairs; Branch of FDA which is responsible for district offices and therefore also controls the inspections of manufacturers.

Operational qualification: OQ is the process of demonstrating that an instrument will function according to its operational specification in the selected environment

OTC: Over-the-Counter; Type of pharmaceutical product which can be sold without a prescription.

Performance qualification: PQ is the process of demonstrating that an instrument consistently performs according to a specification appropriate for its routine use. Important here is the word ‘consistently’. The test frequency is much higher than for OQ. Another difference is that PQ should always be performed under conditions that are similar to routine sample analysis. For a chromatograph this means using the same column, the same analysis conditions and the same or similar test compounds. PQ should be performed on a daily basis or whenever the instrument is used. The test frequency not only depends on the stability of the equipment but on everything in the system that may contribute to the analysis results. For a liquid chromatograph, this may be the chromatographic column or a detector’s lamp. The test criteria and frequency should be determined during the development and validation of the analytical method. In practice, PQ can mean system suitability testing, where critical key system performance characteristics are measured and compared with documented, preset limits. For example, a well characterized standard can be injected 5 or 6 times and the standard deviation of amounts are then compared with a predefined value. If the limit of detection and/or quantitation are critical, the lamp’s intensity profile or the baseline boise should be tested. Table 6 gives a recommendation for a PQ example.

PMA: Pre Market Approval (application); it is required for FDA approval of new or substantially new medical devices. The sponsor furnishes data to support the safety, reliability, and effectiveness of the subject device in this application.

Prosecution: A criminal action taken against a company or individual, charging violation of the law.

Qualification: Verification that equipment is appropriate and correct for the process(es) being investigated or validated.

Quality: The ability to consistently meet customer needs and expectations as well as regulatory requirements while developing full utilization of resources used in the process.

Quality Assurance: Planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

Quality Control: Operational techniques and the activities used to fulfill the requirements of quality.

Quality Cost: Analysis of costs involved in maintaining quality in the following areas: preventive costs, appraisal costs, and failure cost.

Quality System: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

Quality System Regulation: The regulation that embodies the required good manufacturing and documentation practices required for the design and manufacture of medical devices.

Recall (or field correction): Action taken by a firm to remove a product from the market (or to correct a problem at the product's location). Recalls may be conducted on a firm's own initiative, by FDA request, or in some cases by FDA order under its legal authority. A Class I recall involves the most serious risk to users, a Class III recall the least serious.

Rework: Process undertaken when product does not conform to specifications but can be corrected, so that the manufacturer will be able to sell it.

Seizure: An action to remove a violative product from the market by requesting a court to direct a U.S. Marshal to take possession of goods until a matter is resolved.

SMDA: Safe Medical Devices Act

SOP: Standard Operating Procedure; SOPs are required to exist and be followed under GMP regulations to ensure that all products are manufactured in a state of control.

Traceability: The ability to trace the history, application, or location of an item or activity and like items or activities by means of recorded identification.

USC: United States Code

Validation: The establishment of documented evidence that a system does what it purports to do.

Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Warning Letter: An informal written advisory to a firm, communicating FDA's position on a matter but not committing the agency to take enforcement action.

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