Glossary

The EudraGMDP Glossary is included to ensure you can quickly learn the definition of a particular term or used within the GMP Certificate and MIA document creation processes.

A

Active Pharmaceutical Ingredient

Any substance, or mixture of substances, intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Active Substance

Active Pharmaceutical Ingredient.

API

Active Pharmaceutical Ingredient.

B

Business Rule

A rule that is used to define process flow and validation - declaration of policy or conditions that must be satisfied.

C

CA

"Glossary"

CAP

Centrally Authorised Product(s).

Centralised Procedure

A process undertaken by the EMA on behalf of all MS – CAP authorisation process

Competent Authority

An organisation in an EEA Country responsible for the authorisation and supervision of medicinal products. Alternative abbreviation is the : CA.

Compilation of Community Procedures

The Compilation of Procedures is a collection of GMDP inspection-related procedures and forms agreed by the GMDP inspectorates of all the Member States and are designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information.

D

Dosage Form

The form of the completed pharmaceutical product, e.g. tablet, capsule, injection, elixir, suppository.

E

EC

"Glossary"

ECD

Eudra Common Directory

EDQM

European Directorate for the Quality of Medicines

EEA

European Economic Area, includes the EU Member States, Iceland, Liechtenstein and Norway.

EMA

European Medicines Evaluation Agency London based EEA agency also known as European Medicines Agency.

EudraGMDP

The web-based EMA managed application designed to rationalise and centralise the issuing and recording of Good Manufacturing Practice Certificates and Manufacturing Importation Authorisations by NCA Inspectors.

EudraGMDP Administrator

An individual within an NCA or EMA who is responsible for allocating user roles and for the maintenance aspects of the EudraGMDP user group and database.

EUDRANET

European Union Drug Regulatory Authorities Network. The computer network infrastructure connecting the NCAs, the EMA and the "Glossary".

Eudra SSO

The EudraNet Single Sign On username and password system, allowing users access to multiple web-based applications through a single server authentication process.

European Commission

The "civil service" of the European Union. Its full name is the Commission of the European Communities; however, it is often shortened to “the Commission”. It is the executive arm of the European Union. It proposes Community policy and legislation, implements the decisions taken by the Council of Ministers, and supervises the day-to-day running of Commission policies. It is the "guardian" of the Treaties and can initiate action against Member States that do not comply with EC rules.

EuroPharm/EudraPharm

EuroPharm is a database of information on all medicinal products, for human or veterinary use, authorised in the European Union. EuroPharm has been established to fulfil Articles 57.1 (l) and 57.2 of Regulation 726/2004. It is now known as EudraPharm.

F

G

GMDP

Good Manufacturing Practice

Good Manufacturing Practice (GMDP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification. GMDP is concerned with both production and quality control.

GMPC

GMP Certificate

GMP Certificate

A Certificate issued to a manufacturer who has met the standards laid out under the GMDP guidelines.

GMDP compliance

Adherence to GMDP standards.

GMDP Information

Relates to information contained within a GMP Certificate or Non-compliance report.

H

I

IMP

"Glossary"

Investigational medicinal product

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 authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form.

Inspection

On-Site assessment of the compliance with the Community GMDP principles performed by officials of Community Competent Authorities or authorities found equivalent under a Mutual Recognition Agreement.

Inspection report

Report prepared by the official representing the Competent Authority stating whether the company inspected in general complies with the Community GMDP principles and/or the product and process related issues arising from the assessment of the application.

Inspecting Competent Authority

The Competent Authority that has undertaken the inspection (either and NCA or MRA).

Inputting Competent Authority

The Competent Authority that is undertaking the work to enter the information into the EudraGMDP system.

J

K

L

M

 

MAA

Marketing authorisation Application

Across all European markets, plus Australia, New Zealand, South Africa, and Israel (exceptions amongst major markets include USA, Canada, China and Japan), the Marketing authorisation Application (MAA) is a common document used as the basis for a marketing application (an application for approval to market the product based on a full review of all quality, safety, and efficacy data, including clinical study reports). In the USA, the New Drug Application (NDA) is the MAA equivalent. In Canada, the New Drug Submission (NDS) is the MAA equivalent. An MAA is comprised of 4 parts:

Part 1: Summary of the Dossier includes application forms, summary of Product Characteristics, packaging, Expert Reports.

Part 2: Chemical, Pharmaceutical, and Biological Documentation: drug substance and drug product

Part 3: Pharmacological and Toxicological (Preclinical) Documentation is a report of all animal pharmacology, toxicology, and pharmacokinetics studies.

Part 4: Clinical Documentation is a report of all Phase I, II, III, IV, V clinical studies conducted up to the time of submission.

MAH

Marketing authorisation Holder

Manufacture

All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of medicinal products and the related controls

Manufacturer

Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001/83/EC for human products and Article 44 of Directive 2001/82/EC for veterinary products.

Manufacturing Authorisation

Required prior to the commencement of production – application will trigger a GMDP inspection.

Marketing Authorisation Holder

Marketing Authorisation Holder is a person who has applied and received a Pan EEA right to market and sell a product in a pharmaceutical form or a set of pharmaceutical forms.

MIA

Manufacturing / Importers Authorisation.

Medicinal product

Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

Member State

A country member of the European Union.

MR

Mutual Recognition

A community registration procedure described by Council Directive 75/319/EEC (as amended) for the authorisation of medicinal products. Mutual Recognition Procedure: One of the routes for seeking regulatory approval in the European Union. A submission is first made to a EU Member State authority that assesses, grants a national approval and prepares an assessment report. This report is circulated by the initial authority to the other (concerned) Member States who are expected to recognize this decision and grant their own national authorisation within a period of 90 days following the initial approval. The 90-day period is used to resolve any issues between Member States. If serious objections are raised then the application is referred to the CHMP for arbitration leading to a binding decision.

Note: Concerned Member State: A Member State that is concerned (i.e. included in the mutual recognition phrase) with an application for Mutual Recognition, and expected to recognize the initial approval of the Reference Member State.

MRA

Mutual Recognition Agreement.

An agreement between 2 regulatory agencies to recognize the regulatory assessment or inspection of a site (for "Glossary" compliance) or review (pharmaceutical devices) conducted by one another.

MRA countries

Australia, Switzerland, New Zealand, Canada and Japan.

MS

"Glossary"

MS CA

"Glossary"

N

NCA

National Competent Authority

NCR

Non-Compliance Report

O

P  

Packaging

All operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product.Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not finally packaged, primary containers.

PDF

Portable Document Format. Adobe Systems’ Portable Document Format or PDF is an open file format created in 1993 It is used for representing two-dimensional documents in a device independent and resolution independent fixed-layout document format. Each PDF file provides a complete description of a 2D document including all of its constituent elements – fonts, images, text and graphics. The .pdf file format is now being prepared for submission as an ISO standard.

Planned Inspection

A planned inspection is a set of additional information that is provided when a GMDP certificate is first created.

The Planned Inspection may be considered as the first step in the creation of a GMP Certificate, allowing inspectors from multiple NCAs to work together on planning inspections on third country site. The Planned Inspection falls into two categories:

a) It remains as a Draft GMP Certificate until the planned inspection is actually concluded and the certificate is submitted.

b) It is accessible to all NCAs with appropriate access (EUDRANET) via the ‘Search Planned Inspections’ module.

It is hoped that users will search for any planned inspection on a particular site in order to provide more efficient collaborative inspection coverage of distant sites.

Planned Inspections may also be found within the Draft GMP Certificates area for colleagues of the author of the Planned Inspection (i.e. belonging to the same NCA).

Q

QC

Quality Control

Quality Control enacts the SOP, monitoring and recording the activity of the process.

QC Lab

A laboratory that undertakes role of validating the quality of the products produced by manufacturers (Active substance and medicinal).

R

Rapid Alerts

The process by which information is disseminated to the field on the event of a product failure.

Radio Button

A term to describe a circular check box, which is part of a related group. Only one radio button can be activated in one group at one time.

Rights

Privileges assigned to a user that control the access to functionality and visibility of information stored within EudraGMDP.

S

Secondary packing

Secondary packing refers to additional packaging beyond the actual container in which a medicinal product is stored.

SOP

Standard Operating Procedure

Detailed, written instructions to achieve uniformity of the performance of the special functions. These provide a general framework enabling the efficient implementation and performance of the functions and activities for a particular process.

T

U

V

W

W3C

The World Wide Web Consortium

The World Wide Web Consortium is an international organization, comprising Member organizations, a full-time staff and the public working together to develop Web standards.

X

XML

eXtensible Mark-up Language

A standardised language used for the creation and formatting of web documents, formalised by the W3C.

Y

Z