Bio- Pharm Industy Terms 

Term

Acronym

Definition

"3A Sanitary Standards and Accepted Practices"
(Sanitäts Standards und anerkannte Methoden)

3A

( 3 Associations
- 3 Verbände)

Determines criteria for the cleanability of dairy processing equipment.
They have been adopted by many other liquid processing industries
outside of dairy.

"American Society of Mechanical Engineers"
(Berufsverband der Maschinenbauingenieure)

ASME

Creates consensus standards for Mechanical Engineering

"American Society for the Testing of Materials"
(Amerikanische Gesellschaft für Prüfmaterialien)

ASTM

Creates consensus standards for material quality and material quality testing methods.

"BioProcessing Equipment Committee" (Komitee für bioverarbeitende Anlagen)

BPEC

A sub-committee of ASME.
It creates engineering standards for the design, specification, manufacture and documentation of equipment used for biopharm processes.

"Clean in Place"

CIP

The technique of cleaning process line components without the need for relocation or disassembly.

"Comite Europeen de Normalisation"
(Europäisches Komitee für Normung)

CEN

Committee for European Standardization
Creates standards that reflect the best practices in each industry and is supported by DIN and ISO.

"Current Good Manufacturing Practices"
(Aktuelle Warenherstellungsmethoden)

cGMP

Current design and operating practices developed by the pharmaceutical industry to meet FDA requirements as published in the Code of Federal Regulations. They reflect the least common denominator of practices in the industry at present.

"Deionized or Deionization"
(Entionisiert oder Entsaltzung)

DI

Process of the extraction of deionized water through ion exchange resins.

"Deionized Water"
(Vollentsalztes Wasser)

DIW

"Deutsches Institut für Normung"

DIN

German Institute for Standardization
Creates engineering standards for Germany and is contributing body to CEN and ISO..

"Electro-Polish"
(Elektro-Polieren)

EP or E/P

Electrochemical polishing process for metal components where metal ions are removed from the surface of the metal.

"European Hygienic Equipment Design Group"

EHEDG

The group’s objective is to provide standardization organizations
(CEN and ISO) with specialist views on hygienic and aseptic design by publishing requirements and test methods. Accredited bodies carry out cleaning tests which are certified if successful.

"European Pharmacopoeia"
(Europäisches Pharmakopöe - Arzneibuch)

EP

European counterpart to USP. A private, non-profit organization that sets standards for drugs, drug ingredients, medical devices and diagnostics..

"Food and Drug Administration (USA)" (Arzneimittelzulassungsbehörde)

FDA

Enforcement agency of the U.S. Government for food, drug and cosmetics manufacturing. Author of the U.S. cGMP’s. Responsible for new product approvals, plant inspections and product recalls.

"International Standards Organization" (Internationale Organisation für Normung)

ISO

Creates consensus standards for engineering and quality systems.

"Mill Test Report or Material Test Report" (Fabriken Test Bericht oder Material Test Bericht)

MTR

A document certifying the composition of a metal from a particular heat batch.

"Point of Use"
(Gebrauchspunkt)

POU

A valve outlet in a recirculation utility system (typically a water system).

"Purified Water"
(aufbereitetes Wasser)

PW

Ingredient water (not for injection) or rinse water for pharmaceutical products conforming to USP guidelines. Obtained by distillation, reverse osmosis, ion exchange or any other suitable process.

"Steam in Place"

SIP

Sanitization of process line components by the use of steam without the need for relocation or disassembly.

"Total Oxidizable Carbon or Total Organic Carbon"
(Vollständig oxidierbarer Kohlenstoff oder vollständig organischer Kohlenstoff)

TOC

A measure of the amount of organic compounds in a water sample. Carbon is oxidized and the level of CO2 is measured. The proposed USP water standards are based on TOC analysis.

"United States Pharmacopoeia or United States Pharmacopoeia Convention"
(US Arzneibuch oder US Arzneibuch Versammlung)

USP or USPC

A private, non-profit organization that sets standards for drugs, drug ingredients, medical devices, and diagnostics. The FDA enforces the established standards.

"Water for Injection"
(Wasser zur Einspritzung)

WFI

Water for use as a solvent for the preparation of parenteral products conforming to USP guidelines. Obtained most commonly by distillation.