Glossary

The technology of using separating environments, whether protecting the world from a product or the product from the world. Containment, barrier isolation and isolation all refer to the same technology, which is enclosing an environment. In the interest of clarifying the existing confusion between the terms “isolators” and “barriers”, and providing authoritative implementation and validation of isolation technology, the Parenteral Drug Association (PDA) published in October 2000 the Draft for Technical Report No. 34 “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products”. There are, however, some redefining terms that are gaining favor:1.Containment – protect the world from the product (as in the case of highly potent compounds or a toxic).2.Isolation – protect the product from the world (as in the case of a sterile product).3.ISO 14644-7 “Minienvironments and Isolators” will define further levels of devices.NOTE: Isolators, whether operated in a closed or open manner, offer significant advantages over barrier systems: isolators can be decontaminated using reproducible and validated methods, isolators do not allow the ingress of airborne contamination from the surrounding environment, and the introduction of personnel borne contamination into the isolator is precluded. In contrast, a barrier system is an open system that can exchange unfiltered air with the surrounding environment, can only be manually disinfected, and is directly accessed by gowned personnel.

Building Automation System

Substance whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs.

An electropositive element or radical that unites with an acid to form a salt. Or, a substance that when dissolved in water, dissociates to produce one or more hydroxyl ions (OH-). Strong bases or alkalis are irritating and may damage tissue.

A key component of DNA and RNA molecules. Four different bases are found in DNA: adenine (A), cytosine (C), guanine (G), and thymine (T). In RNA, uracil (U) substitutes for thymine. Also known as nitrogenous bases. A base, a phosphate molecule and a sugar joined together constitute a nucleotide.

The part of the booklet label which is applied to the primary or secondary packaging of the IMP. Parts of the base label are not covered by the country specific information of the “book”, but visible to the site and subject at all times; also named “Binding Area” or “Opening/Closing area”. This area could be placed left and/or right of the country specific “book”.

Two nucleotides that are in different nucleic acid chains and whose bases pair by hydrogen bonding. In DNA, the nucleotide bases are adenine (A) that always pairs with thymine (T) and guanine (G) which pairs with cytosine (C). In RNA molecules, adenine (A) joins the uracil (U). Two strands of DNA are held together in the shape of a double helix by the bonds between these pairs.

The order of nucleotide bases in a DNA molecule; determines structure of proteins encoded by that DNA.

A method, sometimes automated, for determining the base sequence.

(NIST) A specification or product that has been formally reviewed and agreed upon, that serves as the basis for further development, and that can be changed only through formal change control procedures.

In some analytical procedures a sample is dissolved in water or combined with other reagents for analysis. A “blank” or standard consisting of the same reagents may be analyzed without sample present. This provides a comparative reference point, or baseline, so that the test results can be attributed solely to the sample itself.

A series of industry publications developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts. The Guides document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices. They are intended to:- Establish a baseline approach to new and renovated facility design, construction, commissioning, and qualification that is based upon clear understanding of the type of product and its manufacturing process.- Prioritize facility design features based upon the impact on product and process.- Avoid unnecessary spending on facility features that do not contribute to consistent production of quality products.The Guides include five product manufacturing operation based guides (vertical guides), and four support system/function based guides (horizontal guides). Published Guides include:1.Volume 1; Bulk Pharmaceutical Chemical (1996). Superseded by Volume 1, 2nd Edition  Active Pharmaceutical Ingredients (June 2007)2.Volume 2; Oral Solid Dosage Forms (1998). Superseded by Volume 2, 2nd Edition (November 2009)3.Volume 3; Sterile Manufacturing Facilities (January 1999). Superseded by Volume 3, 2nd Edition – Sterile Product Manufacturing Facilities (September 2011)4.Volume 4; Water and Steam Systems (January 2001). Superseded by Volume 4, 2nd Edition (December 2011)5.Volume 5; Commissioning and Qualification (March 2001)6.Volume 6; Biopharmaceutical Manufacturing Facilities (June 2004)7.Volume 7; Risk-Based Manufacture of Pharmaceutical Products (September 2010)

A series of industry publications developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts. The Guides document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices. They are intended to:- Establish a baseline approach to new and renovated facility design, construction, commissioning, and qualification that is based upon clear understanding of the type of product and its manufacturing process.- Prioritize facility design features based upon the impact on product and process.- Avoid unnecessary spending on facility features that do not contribute to consistent production of quality products.The Guides include five product manufacturing operation based guides (vertical guides), and four support system/function based guides (horizontal guides). Published Guides include:1.Volume 1 ; Bulk Pharmaceutical Chemical (1996). Superseded by Volume 1, 2nd Edition; Active Pharmaceutical Ingredients (June 2007)2.Volume 2 ; Oral Solid Dosage Forms (1998). Superseded by Volume 2, 2nd Edition (November 2009)3.Volume 3; Sterile Manufacturing Facilities (January 1999)4.Volume 6; Biopharmaceutical Manufacturing Facilities (June 2004)5.Volume 4; Water and Steam Systems (January 2001)6.Volume 5; Commissioning and Qualification Guide (March 2001)

Beginner's All-purpose Symbolic Instruction Code

A high-level programming language intended to facilitate learning to program in an interactive environment.

Firmware that activates peripheral devices in a PC. Includes routines for the keyboard, screen, disk, parallel port and serial port, and for internal services such as time and date. It accepts requests from the device drivers in the operating system as well from application programs. It also contains autostart functions that test the system on startup and prepare the computer for operation. It loads the operating system and passes control to it.

Reproduce by basidiospores, which are extended from the stalks of specialized cells called the basidia. The class comprises Photobasidiomycetes (smuts and rusts) and the Hymenomycetes (mushrooms and puffballs).

The carrier, composed of one or more excipients, for the active substance(s) in semi-solid and solid preparations.

Blood Availability and Safety Inventory System (HHS)

(1998 Edition) A design document that describes what the purpose of a given system is and how the system will accomplish its required task. This document is authored previous to the issuance of bid specifications and is often used to develop them. Until the system is developed this is a conceptual document.

A “dynamic” design document that describes the purpose of a given system and/or facility and how they will accomplish their required tasks. This document is created and approved before the issuance of bid specifications and may be used to develop them. Until the system is developed this is a conceptual document.

Narrative explaining all assumptions or clarifications made in developing an estimate.

Best Available Control Technology for existing direct discharges (EPA)

(IEEE) Pertaining to a system or mode of operation in which inputs are collected and processed all at one time, rather than being processed as they arrive, and a job, once started, proceeds to completion without additional input or user interaction.

(ICH Q7) A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production lot. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.