Glossary

A highly heat and chemical resistant dormant inclusion (spore) occurring within the substance of certain genera of bacteria, mainly Bacillus and Clostridium.

An endogenous protein that blocks the proliferation of blood vessels.

A layer of flat cells that line the tumor blood vessel structure.

A physical or chemical change that requires or is accompanied by the absorption of heat.

Cell wall debris (lypopolysaccharide) from Gram-negative bacteria.

A poisonous molecule in the form of a fat/sugar complex (lipopolysaccharide) that forms an integral part of the bacterial (gram-negative bacteria) cell wall and is only released when the integrity of the wall is disturbed and can cause septic shock and tissue damage. Certain organisms may release endotoxins (e.g. E. coli) during biosynthesis of a recombinant DNA product, thus necessitating purification steps to ensure their removal. In water treatment, it most often refers to pyrogens.

Cell wall debris (lipopolysaccharide) from Gram-negative bacteria.

Pyrogens from certain Gram negative bacteria. Generally highly toxic Lipopolysaccharide-protein complexes (fat, linked sugars, and protein) from cell walls. A marker for these bacteria with a reputation for persistent contamination because they tend to adhere to surfaces.(also see: Pyrogen)

Pyrogens from certain Gram negative bacteria. Generally highly toxic Lipopolysaccharide-protein complexes (fat, linked sugars, and protein) from cell walls. A marker for these bacteria with a reputation for persistent contamination because they tend to adhere to surfaces.

A medicinal product that is administered to a clinical trial participant to measure the effect of the IMP or other relevant clinical endpoint.

European Norms Electrical Certification

A process by which qualified individual(s) review proposed or actual engineering design changes for their cost and/or schedule impact on the project, approve or deny the requests, and manage their implementation. Engineering change management is good engineering practice, to effectively manage project execution and associated costs and schedules.

(ASTM E2500) Prior to system or facility acceptance, changes managed by an approved through SMEs. Changes affecting Critical Aspects should be communicated to the Quality Unit.

Templates, advisable designs and best practices whose project application is optional.

A legally binding, comprehensive, easy to follow set of instructions, statements and practices to procure materials and workmanship for building, installation and execution of engineering projects.

Mandatory minimum requirements presented in a flexible format fitting the topic, that apply to new construction projects and improvements in design, construction, and testing. Engineering Standards represent value-added, cost-effective applications as well as efficient operation and maintenance practices.

A documented review of the engineering design, at an appropriate stage in a project, for conformance to operational and regulatory expectations.

A documented review of the design, at an appropriate stage in a project, for conformance to operational and regulatory expectations.

Required for “Direct Impact” systems. Enhanced documentation may involve additional tests, documentation, QA change control and QA review and approval.

Collection of Engineering, Quality Control, and Regulatory Affairs documents which will be required for the operation, validation, maintenance, and regulatory compliance of a pharmaceutical plant.

Adds change control and validation to Good Engineering Practice.

Required for “Direct Impact” Systems. A collection of documents that may involve additional tests, Quality Assurance change control, review, and approval.

A standard interface for hard disks introduced in 1983 which provides for faster data transfer compared to ST-506.

To consent to and enter a clinical trial.

European Standards