A List of Pharmaceutical Terminology (A-J)
Acceptance criteria
Numerical limits, ranges or other suitable measures for acceptance of test results.
Acceptance quality limit (AQL)
The quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling.
Accuracy
The degree of agreement of test results with the true value or the closeness of the results obtained by the procedure to the true value.
Action limit
The action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results outside these limits will require specified action and investigation.
Air-handling unit (AHU)
The air-handling unit serves to condition the air and provide the required air movement within a facility.
ALCOA
A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”.
ALCOA+
A commonly used acronym for “attributable, legible, contemporaneous, original and accurate” that puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.
Audit
A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
Audit trail
The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GxP records. An audit trail provides for a secure recording of life cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record.
Batch
A defined quantity of starting material, packaging material or product, processed in a single process or series of processes, so that it is expected to be homogeneous.
Certificate of analysis (COA)
A document listing the results of testing a representative sample drawn from the batch to be delivered.
Change control
The processes and procedures to manage system changes.
Clean room
A room or area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area.
Cleaning validation
Documented evidence to establish that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration factors such as batch size, dosing, toxicology, and equipment size.
Clinical trial
Any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, and/or identify any adverse reaction to, investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety. Clinical trials are generally divided into Phases I-IV.
Colony-forming units (cfu)
A unit of measure of the level of microbial contamination of a product.
Comparator product
A pharmaceutical product with which the generic product is intended to be interchangeable in clinical practice.
Computerized system
A process or operation integrated with a computer system.
Data
All original records and true copies of original records, including source data and metadata,
Data integrity
The degree to which data are complete, consistent, accurate, trustworthy and reliable and to which these characteristics of the data are maintained throughout the data life-cycle.
Design qualification (DQ)
Documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of GMP.
Design space
The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.
Deviation
Departure from an approved instruction or established standard.
Dossier
The regulatory submission package submitted to the national regulatory authority as an application for marketing authorization in line with the applicable country requirements and requirements specified in the respective Procedure guidelines.
Excipient
A substance or compound, other than the active pharmaceutical ingredient and packaging materials, that is intended or designated to be used in the manufacture of a pharmaceutical product.
Expiry date
The date at which the product is no longer considered acceptable for use.
Essential Medicines
Essential medicines are those that satisfy the priority health care needs of the population.
Fixed Dose Combination (FDC) Product
A combination of two or more active substances in a fixed ratio of doses. This term is used generically to mean a particular combination of active substances irrespective of the formulation or brand.
Forecasting
Evidence-based expectations on sales, budget requirements, demand, projected health gain/outcome and similar.
Gap analysis
Identification of critical elements of a process which are available at the sending unit (SU) but are missing from the receiving unit (RU).
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Good distribution practices (GDP)
Good distribution practices are that part of quality assurance that ensures that the quality of a pharmaceutical products is maintained by means of adequate control of the numerous activities which occur throughout the distribution process.
Good Manufacturing Practices (GMP)
That part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
Good practices (GxP)
An acronym for the group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as GLP, GCP, GMP, good pharmacovigilance practices (GVP) and good distribution practices (GDP).
Heating, ventilation and air-conditioning (HVAC)
Heating, ventilation and air-conditioning, also referred to as environmental control system (ECS).
Harmonization (regulatory)
The process by which technical guidelines are developed to be uniform across participating authorities.
Hybrid system
The use of a combination of electronic systems and paper systems.
Impurity
Any component present in the intermediate or API that is not the desired entity.
Innovator pharmaceutical product
Generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization.
Inspection
An on-site evaluation by a regulatory authority of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with regulatory requirements and or commitments made as part of the approval to market a product.
Installation qualification (IQ)
The performance of tests to ensure that the installations (such as machines, measuring devices, utilities and manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.
Internal audit
An examination and assessment of all or part of a QMS with the specific purpose of improvement.
ISO 14644
International standard relating to the design, classification and testing of clean environments.
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