acceptance criteria, [ICH Q6ANumerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures.][ICH Q7Numerical limits, ranges, or other suitable measures for acceptance of test results.]
acceptable operating range (AOR)
acceptable quality level (AQL)
active controls ICH Q13 DraftA system consisting of hardware and software architecture, mechanisms, and algorithms that automatically adjust a process to maintain the process output within a desired range. Examples include feedforward and feedback controls.
active pharmaceutical ingredients (API) (or drug substance) ICH Q7Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
annual product review (APR) Code of Federal RegulationsWritten records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.
batch (or lot) ICH Q7A 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. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
batch number (or lot number) ICH Q7A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined.
biological license application (BLA)
breakthrough therapy designation (BTD)
capability of a process ICH Q10Ability of a process to realize a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statistical terms.
CAPA effectiveness verification (CEV)
certificate of analysis (CoA)
certificate of testing (CoT)
change management ICH Q10A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.
change record (CR)
chemistry, manufacturing, and controls (CMC)
Chinese hamster ovary (CHO)
Code of Federal Regulations (CFR)
coefficient of variation (CV)
continued process verification (CPV)
contract manufacturer ICH Q7A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer.
control strategy (CS) ICH Q10A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.
control strategy summary (CSS)
corrective action ICH Q10Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
corrective action and preventive action (CAPA) ICH Q12System that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their occurrence.
critical ICH Q7Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the API meets its specification.
critical material attribute (CMA)
critical process parameter (CPP) ICH Q8(R2)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.
critical quality attribute (CQA) ICH Q8(R2)A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
critical to quality (CtQ)
cross contamination ICH Q7Contamination of a material or product with another material or product.
design space ICH Q8(R2)The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.
deviation ICH Q7Departure from an approved instruction or established standard.
disturbances ICH Q13 DraftUnplanned changes to process inputs beyond normal operating range or conditions (e.g., process parameter, material property, equipment condition, or environment) that are introduced into a system.
diversion ICH Q13 DraftProcedure in which materials are isolated and separated from the product stream in the manufacturing process.
drug product (DP)
drug substance (DS) ICH Q7Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
electronic data capture (EDC)
electronic data management system (EDMS)
established conditions (ECs) ICH Q12ECs are legally binding information considered necessary to assure product quality. As a consequence, any change to ECs necessitates a submission to the regulatory authority.
European Medicines Agency (EMA)
European Pharmacopoeia (Ph. Eur.)
executed batch record (EBR)
expiry date (or expiration date) ICH Q7The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.
failure modes, effects, and criticality analysis (FMECA)
impurity ICH Q7Any component present in the intermediate or API that is not the desired entity.
impurity profile ICH Q7A description of the identified and unidentified impurities present in an API.
in-process control (IPC) (or Process Control) ICH Q7Checks performed during production in order to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or API conforms to its specifications.
intermediate ICH Q7A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this Guide only addresses those intermediates produced after the point that the company has defined as the point at which the production of the API begins.)
International Organization for Standardization (ISO)
Key Process Parameter (KPP). WARNING - per FDA/EMA Q&A (2013), "The Agencies do not support the use of the term Key Process Parameters (KPP) since it is not an ICH terminology. Furthermore, experience reveals that different applicants use the term “key” differently, leading to more difficult internal communication."
lifecycle ICH Q8(R2)All phases in the life of a product from the initial development through marketing until the product’s discontinuation.
limit of detection (LOD)
limit of quantitation (LOQ)
lot number ICH Q7A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and distribution history can be determined.
model maintenance ICH Q13 DraftA set of planned activities over the product lifecycle to monitor and sustain the model’s performance to continually ensure its suitability for the intended and approved purpose.
multivariate statistical process control ICH Q13 Draft The application of multivariate statistical techniques to analyse complex process data with potentially correlated variables.
Post-approval CMC commitment ICH Q12Commitment by the MAH to undertake specific CMC activities to be implemented during the commercial phase.
preventive action ICH Q10Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. NOTE: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
prior approval ICH Q12Change to an approved established condition that requires regulatory review and approval prior to implementation.
procedure ICH Q7A documented description of the operations to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of an intermediate or API.
process dynamics ICH Q13 Draft The response of a manufacturing process to changing conditions or transient events.
product quality review ICH Q12Regular periodic review of API or drug products with the objective to verify process consistency, to highlight any trends and to identify product and process improvements
proven acceptable range (PAR) ICH Q8(R2)A characterised range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria.
qualification ICH Q7Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
qualified small scale model (QSSM)
quality ICH Q6AThe suitability of either a drug substance or a drug product for its intended use. This term includes such attributes as the identity, strength, and purity.
quality assurance (QA) ICH Q7The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.
quality by design (QbD) ICH Q8(R2)A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
quality control (QC) ICH Q7Checking or testing that specifications are met.
quality target product profile (QTPP) ICH Q8(R2)A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.
quality unit(s) ICH Q7.An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
quantitation limit (QL)
real time release testing (RTRT) ICH Q8(R2)The ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls.
reference standard, primary ICH Q7A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognised source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.
reference standard, secondary ICH Q7A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.
relative standard deviation (RSD)
risk evaluation and mitigation strategy (REMS) A drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
rest of world (ROW)
retest date ICH Q7The date when a material should be re-examined to ensure that it is still suitable for use.
reworkingICH Q7Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).
room temperature (RT)
root cause analysis (RCA)
run time ICH Q13 DraftThe time interval used to produce a quantity of output material.
sample management plan (SMP)
size exclusion chromatography (SEC)
specification [ICH Q6AA list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. "Conformance to specifications" means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.] [ICH Q7A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. “Conformance to specification” means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.]
standard operating procedure (SOP)
state of control ICH Q10A condition in which the set of controls consistently provides assurance of continued process performance and product quality.
steady state ICH Q13 DraftA stable condition that does not change over time.
submission ICH Q12 Communication to a regulatory authority regarding a change to an established condition that could be prior approval or notification.
technology transfer (TT)
transient events ICH Q13 DraftA temporary condition in which a process goes through a dynamic change. This change may be due to a disturbance or an intentional alteration in the selected operating conditions (e.g., start-up, shutdown, changes from one operating condition to another).
United States Code of Federal Regulations (US CFR)
United States Pharmacopoeia (USP)
well-controlled critical process parameter (WC-CPP)