CMC Terms (22)

Accelerated Stability is used to prevent quality failures and strengthen manufacturing control strategy.

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

Analytical METHOD Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.

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

CGMP is foundational for process control, product quality, and inspection-readiness in manufacturing.

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

Cleaning Validation is foundational for process control, product quality, and inspection-readiness in manufacturing.

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

CQA is foundational for process control, product quality, and inspection-readiness in manufacturing.

Critical Quality Attribute is used to prevent quality failures and strengthen manufacturing control strategy.

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

Elemental Impurity supports robust CMC packages and defensible quality decisions during review.

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

Genotoxic Impurity is foundational for process control, product quality, and inspection-readiness in manufacturing.

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

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

PPQ is used to prevent quality failures and strengthen manufacturing control strategy.

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.

Q1 Stability is used to prevent quality failures and strengthen manufacturing control strategy.

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

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