Manufacturing Terms (30)

The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.

An analytical method published in an official pharmacopoeia (USP, Ph. Eur., JP) that serves as the recognized standard for testing a specific article.

The planned set of controls, derived from product and process understanding, that ensures process performance and product quality.

A systematic approach to identifying, investigating, and addressing the root causes of quality problems.

A process parameter whose variability has an impact on a Critical Quality Attribute and therefore must be monitored or controlled to ensure product quality.

A physical, chemical, biological, or microbiological property of a drug substance or product that must be within an appropriate range to ensure quality.

The current quality standards FDA enforces for the manufacture, processing, packing, and holding of drug products to ensure identity, strength, quality, and purity.

The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality, enabling operational flexibility within the defined region.

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

Inorganic impurities, principally heavy metals, that may be present in drug products and require assessment under ICH Q3D.

Analytical testing to quantify bacterial endotoxins in parenteral drugs, medical devices, and other products where endotoxin presence could cause pyrogenic reaction.

The EU GMP annex establishing requirements for the manufacture of sterile medicinal products.

The EU GMP annex establishing requirements for computerized systems used in GMP-regulated activities.

An inactive substance used as a carrier or vehicle for the active pharmaceutical ingredient in a drug product.

The quality system covering the organizational process and conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, and reported.

Regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.

The ICH guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

A class of genotoxic impurities that can form during drug substance or drug product manufacturing and require risk assessment and control.

A test result that falls outside the established acceptance criteria or specifications.

A framework for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes.

Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.

Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.

A written document defining the cGMP responsibilities and activities between a drug owner and contract manufacturer or testing facility.

A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

A prospective summary of the quality characteristics a drug product should possess to deliver the intended therapeutic benefit to the patient.

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

The formal process of evaluating and approving suppliers of materials, components, and services used in GMP-regulated manufacturing.

The documented process of moving manufacturing technology and knowledge from one site or party to another to enable production at the new location.