Glossary

A report to identify all bid packages and proposed pre-qualified bidders. The report should list the scope of each bid package along with the contract terms (e.g. lump sum, time and material, not to exceed.)

Overall strategy for execution of the procurement related aspects of a Capital Project.

(ISO) Result of a process.

(PDA) The intended result of activities or processes.

The production of more than one product in a facility, with strict adherence to accepted cleaning procedures between these products.

The production of more than one product in a facility, with strict adherence to accepted cleaning procedures between these products.

The program by which a processing area is cleared of supplies and components used in the manufacture of a previous product and then readied for production of a new product. This often includes parts change over and/or special cleaning to eliminate cross-contamination.

A selection of materials of construction, raw materials and products, and utility fluids in contact with one another that are not reactive with one another, and therefore do not have the potential to negatively impact the product directly or indirectly.

A selection of materials of construction, raw materials and products, and utility fluids in contact with one another that will not interact sufficiently to cause unacceptable changes in the quality of the dosage form.

A part used for a qualified item of equipment or system that is in direct contact.

As defined by the International Association for Food Protection (IAFP) (formerly, International Association of Milk, Food, and Environmental Sanitarians (IAMFES)) “all surfaces that are exposed to the product or from which liquids may drain, drop, or be drawn into the product”. A surface that contacts raw materials, process materials, and/or product.

A surface that contacts raw materials, process materials, and/or product.

Surfaces of process components that are in direct contact with, or have the potential to come in contact with drug product(s) where drug product(s) are defined by owner/user. Examples of product contact surfaces may include the interior surfaces of bioreactors, process tanks, storage vessels, transfer piping/tubing, pumps, chromatography columns, and recirculating segments of CIP systems.(also see: Process Contact Surfaces, Solution Contact Surface)

A product critical instrument is an instrument whose accuracy/failure may have a direct effect on product quality.

An application to the FDA for approval to market a biological in the United States. The FDA determines if a protein pharmaceutical is considered a biological or a drug and whether a PLA or a New Drug Application (NDA), respectively, should be filed to obtain marketing approval.

(ICH Q9) All phases in the life of the product from the initial development through marketing until the product’s discontinuation.

The types and number of different products produced in a facility.

(FDA) Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.

An optional strategy document developed by the manufacturer to assure that any potential contamination in the process is adequately controlled to prevent adverse impact on the drug substance.

ISPE launched its Product Quality Lifecycle Implementation (PQLI) initiative in June 2007 to help industry find practical approaches to the global implementing of ICH Quality Guidelines. Through PQLI, ISPE is spearheading efforts to assist in the implementation of the ICH Quality documents, in particular, ICH Q8, Q9, and Q10, and to support the work of the ICH Implementation Working Group (IWG). Key goals of PQLI include the provision of a technical framework comprising, for example, explanatory documents and illustrative examples, supporting the implementation of enhanced science and risk-based approaches to product realization, technology transfer, commercial manufacture, and its continual improvement in both research- and generic-based organizations.PQLI encompasses the whole of the product lifecycle and comprises three strategic themes:a)Principles of Quality by Design (QbD)b)Pharmaceutical Quality System elementsc)Enablers (knowledge management, quality risk management)These strategic themes represent the key components of the ICH quality vision described at the July 2003 meeting in Brussels which supported the development of the ICH Quality Guidelines. Within PQLI, ISPE has established multi-disciplinary, multi-national teams in support of these strategic themes, addressing them from the perspectives of both small molecule (chemically derived) and biotechnology.PQLI will continue its efforts to assist in the adoption and implementation of the ICH Quality vision to “Develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”.

(ICH Q10) Achievement of a product with the quality attributes appropriate to meet the needs of patients, health care professionals, and regulatory authorities (including compliance with marketing authorization) and internal customers requirements.

Process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The manufacturer/importer/ distributor or a responsible agency might initiate the recall.

The process of separating a desired recombinant protein from the growth medium and the other elements in the host cells in which it was grown.

(ICH Q6B) Molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety.