21 CFR Part 11 – Electronic Records, Electronic Signatures

 

21 CFR Part 58 – Current Good Laboratory Practice (CGLP)

 

21 CFR 210-211 – applies to finished drugs, specifically:

¨      21 CFR Part 210 – Current Good Manufacturing Practice (CGMP) for manufacturing, processing, packing, or holding of drugs, general.

¨      21 CFR Part 211 – Current Good Manufacturing Practice (CGMP) for finished pharmaceuticals.

 

21 CFR 820 – applies to medical devices

 

21 CFR 1404 – GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)

¨      Sec. 1404.930 Debarment. Debarment means an action taken by a debarring official under subpart H of this part to exclude a person from participating in covered transactions and transactions covered under the Federal Acquisition Regulation (48 CFR chapter 1). A person so excluded is debarred.

¨      Sec. 1404.1015 Suspension. Suspension is an action taken by a suspending official under subpart G of this part that immediately prohibits a person from participating in covered transactions and transactions covered under the Federal Acquisition Regulation (48 CFR chapter 1) for a temporary period, pending completion of an agency investigation and any judicial or administrative proceedings that may ensue. A person so excluded is suspended.

¨      Subpart E--Excluded Parties List System Sec. 1404.500 What is the purpose of the Excluded Parties List System (EPLS)? The EPLS is a widely available source of the most current information about persons who are excluded or disqualified from covered transactions.

¨      Subpart H--Debarment Sec. 1404.850 What is the standard of proof in a debarment action?

o   (a) In any debarment action, we must establish the cause for debarment by a preponderance of the evidence.

o   (b) If the proposed debarment is based upon a conviction or civil judgment, the standard of proof is met.

 

483 – An FDA administrative enforcement action following factory inspection, recall or detention requests, notice of refusal of admission of an imported product. Take the form of a written letter describing the issues that facilitated the warning.  See Consent Decree, and 21 CFR 1404.

 

510 K – The application filed with the FDA for a new medical device to show that the apparatus is “substantially equivalent” to one that is currently marketed.

 

Abbreviated New Drug Application (ANDA) – An application filed (with the FDA) for a drug showing that the substance is the same as an existing, previously approved drug (i.e., a generic version).

 

Adverse Drug Event (ADE) – Post-market adverse drug events consist of an undesired side effect, death, or the lack of a desired effect associated with drugs administered to humans. The reporting system is used to identify adverse effects not detected during pre-market testing of FDA-approved drugs. Vaccine Adverse Event Reporting System (VAERS) is used for issues related to vaccines.

 

Adverse Event (AE) – in reference to the full spectrum of pharmaceuticals (drugs), vaccines, and medical devices, AE is similar to ADE but more encompassing; ADE is a subset of AE.

 

ANDA – see Abbreviated New Drug Application

 

ANSI – American National Standards Institute

 

Approval – Once FDA approves the New Drug Application (NDA), the new medicine becomes available for physicians to prescribe. The company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines, FDA requires additional studies (Phase IV) to evaluate long-term effects.

 

ASTM – American Society for Testing and Materials

 

AZ – AstraZeneca

 

Bioequivalence – In pharmaceuticals, the demonstration that a drug’s rate and extent of absorption are not significantly different from the rate and extent of absorption of an existing drug that is already approved by the FDA.

 

BMS – Bristol Meyers Squibb

 

BOM – Bill of Materials

 

C&PC – Consumer and Personal Care Research

 

CANDA – Computer-Assisted New Drug Application

 

CBER – Center For Biologics Evaluation and Research

 

CDER – Center for Drug Evaluation and Research

 

CDISC – Clinical Data Interchange Standards Consortium

 

CDRH – Center For Devices And Radiological Health

 

CDS – Chromatographic Data System

 

Center For Biologics Evaluation And Research (CBER) – The branch of the FDA responsible for the regulation of biological products, including blood, vaccines, therapeutics and related drugs and devices to ensure purity, potency, safety, availability and effectiveness. www.fda.gov/cbe

 

Center For Drug Evaluation And Research (CDER) – The branch of the FDA responsible for the regulation of drug products. www.fda.gov/cde.

 

Center For Devices And Radiological Health (CDRH) – The branch of the FDA responsible for the regulation of medical devices. www.fda.gov/cdrh.

 

CFR – see Code Of Federal Regulations

 

Class I Device – An FDA classification of medical devices. General controls are sufficient to ensure safety and efficacy.

 

Class II Device – An FDA classification of medical devices. Performance standards and special controls are sufficient to ensure safety and efficacy.

 

Class III Device – An FDA classification of medical devices. Pre-market approval is required to ensure safety and efficacy, unless device is substantially equivalent to a currently marketed device. (See “510K”)

 

Clinical Data Interchange Standards Consortium (CDISC) – A new standard for exchange and storage of clinical data that has recently been acknowledged by the FDA.

 

Clinical Research Associate (CRA) – An individual responsible for monitoring clinical trial data to ensure compliance with study protocol and FDA GCP regulations. A representative of either the sponsor or contract research organization (CRO) that is responsible for monitoring the quality of the conduct of the clinical trial.

 

Code Of Federal Regulations (CFR) – The CFR is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. The code is divided into 50 titles that represent broad areas subject to federal regulation. Title 21 of the CFR covers FDA regulations.

 

Computer-Assisted New Drug Application (CANDA) – An electronic submission of a new drug application (NDA) to the FDA.

 

Consent Decree – A punitive action taken by the Department Of Justice on behalf of the FDA. This settlement agreement can involve monetary fines, destruction of product, and stop shipment of products for an indeterminate period of time. This is the most severe penalty that the FDA imposes.

 

COTS – Commercial Off-The-Shelf (software)

 

CPT™ – Current Procedural Terminology

 

CRF – Case Report Form; also Chronic Renal Failure

 

CRA – Clinical Research Associate

 

CRO – Contract Research Organization

 

CRT – Case Report Tabulation

 

CSV – Computer System Validation

 

DCS – (process) Distribute Control Systems

 

Device – In medical product development, according to the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is:

recognized in the official National Formulary or United States Pharmacopoeia or any supplement to them,

 intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or animals or,

intended to affect the structure of the body of man or animals and does not achieve any of its principal intended purposes through chemical action within or on the body of man or animals and is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

 

DIA – Drug Information Association

 

DMB – Data Monitoring Board

 

EDC – Electronic Data Capture

 

EMF – Electro-Magnetic Frequencies

 

ERP – Enterprise Resource Planning

 

FAT – Factory Acceptance Test

 

FCG – First Consulting Group

 

FDA – see Food And Drug Administration

 

Food And Drug Administration (FDA)- The U.S. government regulatory agency responsible for monitoring and enforcing policies that regulates the manufacturing, testing, and marketing of the drugs and devices. The FDA must approve all drugs and devices prior to their commercial availability.

 

FRS – Functional Requirements Specification

 

GAMP – Good Automated Manufacturing Practices (Industry Board or Forum or decided practices, e.g., GAMP3 or GAMP4).

 

GCP – see Good Clinical Practices

 

GLP – see Good Laboratory Practices

 

GMP – Good Manufacturing Practices

 

Good Clinical Practices (GCP) – FDA regulations and guidelines that define the responsibilities of the key figures involved in a clinical trial including the sponsor.

 

Good Laboratory Practices (GLP) – A collection of regulations and guidelines to be used in laboratories where research is conducted on drugs biologics or devices that are intended for submission to the FDA

 

HL7 – Health Level Seven

 

HPLC – High Performance Liquid Chromatography

 

ICD9 – International Classification Of Diseases - Version 9

 

ICH – International Conference on Harmonisation

 

IDE – Investigational New Device Exemption

 

IEEE – Institute of Electrical and Electronic Engineers

 

IFPMA – International Federation of Pharmaceutical Manufacturers Associations

 

INDA – Investigational New Drug Application

 

Investigational new Device Exemption (IDE) – An IDE must be filed with the FDA prior to initiating clinical trials of medical devices considered to pose a significant risk to human subjects.

 

Investigational New Drug Application (INDA) – An IND(A) must be filed with the FDA prior to initiating clinical trials of drugs or biologics.  Application that a drug sponsor must submit to FDA before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including structural formula, animal test results, and manufacturing information.

 

IP – Internet Protocol

 

IQ – Installation Qualification

 

IRB – Institutional Review Board

 

ISO – International Organization for Standardization.

 

ISP – Internet Service Provider

 

ISPE – International Society of Pharmaceutical Engineers

 

IVRS - Interactive Voice Recognition System

 

J&J – Johnson & Johnson

 

LAN – (Local Area Network

 

LC – Liquid Chromatography

 

LIMS – Laboratory Information Management System(s)

 

LC –Liquid Chromatography; Logic Controllers.

 

MDR – see Medical Device Report

 

Medical Device Report (MDR) – Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User-facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer.

 

MedDRA^® – see Medical Dictionary For Regulatory Activities^®

 

Medical Dictionary For Regulatory Activities^® (MedDRA^®) – Designed to supersede or replace all other terminologies used within the medical product development process, including COSTART, WHO-ART, J-ART, and HARTS. Major global regulatory authorities (FDA, EMEA, MHW) are adopting MedDRA and moving toward requiring its use. The FDA has already implemented MedDRA within its Adverse Event Reporting System (AERS). European authorities are beginning to use MedDRA as a key component of their electronic database systems. The MedDRA Maintenance and Support Services Organization (MSSO) was established by the ICH to speed and facilitate the adoption of MedDRA by both the regulatory and medical products manufacturing communities. MSSO is also responsible for making sure the terminology is updated regularly and that it remains responsive to user needs.

 

MRP – Manufacturing Resource Planning Systems

 

MSSO – Maintenance and Support Services Organization

 

MedWatch Program – An FDA program designed to monitor adverse events (AEs) from drugs marketed in the U.S. Through the MedWatch program, health professionals may report ADE’s (sometimes referred to as AEs) voluntarily to the FDA. Drug manufacturers are required to report all ADE’s brought to their attention.

 

NDA – see New Drug Application

 

New Drug Application (NDA) – An application requesting FDA approval, after completion of Phase III studies, to market a new drug for human use in interstate commerce. Clinical trial results generally account for approximately 80% of the NDA.

 

OIT – Operator Interface Terminals

 

OQ – Operational Qualification

 

Orphan Drug – A drug, biologic or antibiotic designated by the FDA as providing therapeutic benefit for an indication (disease or condition) affecting less than 200,000 people in the U.S. Companies that market orphan drugs are granted a period of market exclusivity in return for the limited commercial potential of the drug.

 

OTC – see Over-The-Counter

 

Over-The-Counter (OTC) – Over-the-counter drug products are FDA regulated products that do not require a physician’s prescription. Some examples include aspirin, sunscreen, nasal spray and sunglasses.

 

PDA – Parenteral Drug Association

 

PDF – Portable Document File

 

PhRMA - Pharmaceutical Research and Manufacturers of America

 

PK – Pharmacokinetics

 

PK/PD – Pharmacokinetic and/or Pharmacodynamic

 

PLC – Programmable Logic Controller (also Process-programmable Logic Controller).

 

PMA – Pre-Market Approval

 

Post-Marketing Surveillance – The FDA’s ongoing safety monitoring of marketed drugs.

 

PQ – Performance Qualification

 

Predicate Rule – Requirements set forth in the Act, the PHS Act, or any FDA regulation, with the exception of 21 CFR Part 11 (since it relies upon predicate rules).

 

QA – Quality Assurance

 

QC – Quality Control

 

QRC – Quality and Regulatory Compliance

 

R&D – Research and Development

 

RD&E – Research, Development, and Engineering

 

RS-232-C – Electronic Industries Association (EIA) standard for connecting electronic equipment. Data is transmitted and received in serial format.

 

SAE – Serious Adverse Affects

 

SAS – Database program used in healthcare applications.

 

SAT – Site Acceptance Test

 

SCADA – Supervisory Control and Data Acquisition

 

SCADA - Supervisory Control And Data Acquisition Systems

 

SDLC – Software Development Life Cycle

 

SDLC – System Development Life Cycle

 

SOP – Standard Operating Procedure(s)

 

SQL – Structured Query Language

 

TCP – Transfer Control Protocol

 

TCP/IPTransmission – Control Protocol/Internet Protocol

 

TMDV – Test Method Development and Validation

 

Vaccine – A vaccine reduces preventable infectious diseases so that now few people experience the devastating effects of measles, pertussis and other illnesses. Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.

 

Vaccine Adverse Event Reporting System (VAERS) – is used for issues related to vaccines; see Adverse Drug Event (ADE).

 

VAERS – see Vaccine Adverse Event Reporting System

 

Validation (…FDA) – Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

 

V&V – Verification and Validation

 

VPN – Virtual Private Network

 

WAN – Wide Area Network

 

WHO – World Health Organization

 

XML – eXtensible Markup Language