CMC

Numerical limits, ranges, or other suitable measures for acceptance of test results for a product, process, or control.

A defined procedure for testing a quality attribute (e.g., assay, impurities, dissolution) with specified conditions, system suitability, and acceptance criteria.

The substance or mixture of substances used in the manufacture of a drug product that is intended to furnish pharmacological activity. Same as drug substance.

An analytical test determining the amount or potency of the active ingredient in a drug substance or drug product.

Pyrogenic substances from Gram-negative bacteria that must be controlled in parenteral products, commonly tested via BET methods.

A stability study design where only extremes (e.g., highest and lowest strengths) are tested, assuming intermediate levels behave similarly.

A document reporting test results against specifications for a material or product batch, typically issued by the manufacturer or testing laboratory.

Packaging designed to be difficult for young children to open while remaining accessible to adults (requirements and standards vary).

Demonstration that product quality remains comparable after a manufacturing change, using analytical, nonclinical, and/or clinical data as appropriate.

The ability of a container-closure system to maintain a sterile barrier and prevent ingress of contaminants throughout shelf life.

The sum of packaging components that together contain and protect the dosage form and can affect product quality (e.g., vial + stopper + seal).

A test ensuring dosage units contain the intended amount of active ingredient within defined acceptance criteria.

A planned set of controls derived from product and process understanding that ensures process performance and product quality (including material controls, in-process controls, release tests, and monitoring).

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure desired product quality.

A property of a raw material, intermediate, or component that can impact CQAs and therefore requires control.

The multidimensional combination and interaction of input variables and process parameters that has been demonstrated to provide assurance of quality within defined ranges.

A test measuring the rate and extent of drug release from a dosage form under specified conditions, commonly used as a critical quality attribute for solid orals.

The finished dosage form (e.g. tablet, injection) containing the drug substance and excipients, ready for use by the patient.

The active pharmaceutical ingredient (API) in a drug product. CMC sections describe its manufacture, characterisation, specifications, and stability.

A metal or metalloid contaminant (e.g., Pb, As, Cd, Hg) that may be present from catalysts, raw materials, or equipment and must be assessed and controlled.

An inactive ingredient in a drug product formulation used to aid processing, stability, delivery, or patient acceptability.

Chemical entities that can migrate from packaging, container-closure systems, or manufacturing components into the product; assessed to ensure patient safety and product quality.

Deliberate exposure of a substance/product to stress conditions (e.g., heat, light, oxidation) to understand degradation pathways and develop stability-indicating methods.

A study demonstrating that intermediates or bulk product can be held for defined times/conditions without adverse impact on quality.

Any component of the drug substance or drug product that is not the chemical entity defined as the drug substance or an excipient, including process- or degradation-related impurities.

Checks performed during manufacturing to monitor and, if necessary, adjust the process to ensure the product meets quality requirements.

Stability of a product after first opening, reconstitution, dilution, or other preparation steps under conditions of use.

A stability study design where a subset of samples is tested at each time point, reducing testing burden while maintaining scientific justification.

Demonstration that an analytical method performs appropriately in a receiving laboratory (e.g., QC lab) when transferred from a sending lab (e.g., development).

Documented evidence that an analytical method is suitable for its intended purpose, based on characteristics such as accuracy, precision, specificity, and robustness.

A class of potentially carcinogenic impurities that may form during manufacturing or storage and require risk assessment, testing, and control strategies.

Visible or sub-visible particles in drug products that can affect safety and quality, requiring control and testing (especially for injectables).

Stability behavior of a substance/product upon exposure to light, assessed to support packaging and labeling controls.

Tools and systems for designing, analyzing, and controlling manufacturing through timely measurements of critical attributes to improve process understanding and control.

Studies to understand process parameters and their impact on quality attributes, supporting control strategy and validation justification.

A development approach that emphasizes product and process understanding and control, supported by quality risk management, to ensure consistent quality.

Any material (e.g., reagents, solvents, excipients) used in the manufacture of drug substance or drug product that may require qualification and control.

A well-characterized material used as a benchmark for analytical testing (e.g., assay, impurities), requiring qualification and control.

Acceptance criteria applied at the time of batch release to ensure quality before distribution.

Organic volatile chemicals used or produced in the manufacture of drug substances or excipients that remain as residues and must be controlled for patient safety.

For drug substance, the period during which it is expected to remain within specification and can be retested to confirm suitability for use.

Increasing manufacturing scale (e.g., from pilot to commercial) while maintaining product quality and process performance within a defined control strategy.

The period of time during which a drug product is expected to remain within approved specifications when stored under defined conditions.

Acceptance criteria applied through end of shelf life to ensure quality throughout storage under labeled conditions.

List of tests, references to analytical procedures, and acceptance criteria (limits, ranges) that a drug substance or drug product must meet to be released.

A qualified environmental chamber used to store stability samples at defined conditions (e.g., 25°C/60%RH) with monitoring and alarms.

An analytical method that accurately measures active ingredient and separates it from degradation products, impurities, and excipients over time.

A predefined plan describing storage conditions, time points, tests, and acceptance criteria for stability studies supporting shelf life and storage statements.

A study that evaluates how the quality of a drug substance or product varies with time under the influence of environmental factors (temperature, humidity, light).

Ongoing analysis of stability results to detect trends, shifts, or emerging risks that could affect shelf life or specifications.

A raw material, intermediate, or drug substance used in the production of a drug substance that is a significant starting point for defining the manufacturing process and controls.

Packaging features that provide visible evidence of opening or interference before use.

A structured process for transferring product and process knowledge between development, manufacturing sites, and/or CMOs to ensure consistent product quality.