Correction
Repair, rework, or adjustment relating to the disposition of an existing deviation. (TR88)
Source:
Batch Record Review
Review by the quality control unit of the batch manufacturing record for accuracy and completeness and for absence of derivation from the approved manufacturing and testing processes. The batch record is inclusive of all in-process testing and release records for a batch. (TR88)
Source:
Subvisible particle
A particle with a size <100 µm in diameter. (TR85)
Source:
Aspect Ratio
The length of a particle or fiber divided by its width. (TR85)
Source:
Visible fiber
A fiber-like particle with an aspect ratio ≥5 and a length >300 µm. (TR85)
Source:
Area
Measured surface area of a flat projection of a particle.(TR85)
Source:
Package integrity
Is the measure of the ability of the package to prevent product loss or maintain product sterility and the ability to maintain the internal environment (2). (TR86)
Source:
Audit Trail Review Assessment (ATRA)
A tool that can be used to help determine what elements within the audit trail should be reviewed, and the frequency at which the review should take place for each part of the audit trail where a review is required.
Source:
Subject Matter Experts (SMEs)
Individuals with specific technical expertise such as engineers, quality experts, automation specialists, scientists, etc. (TR54-5)
Source:
Manual Inspection
Consists of manual handling and presentation of filled containers under controlled conditions of lighting and background to allow for human visual inspection. (TR79)
Source:
Tyndall Lighting
Collimated lighting at right angle to the viewing direction, typically against a black or dark background, which is useful during manual visual inspection to detect fine dispersions of small particulate that scatter the light making them more detectable. (TR79)
Source:
Supplemental Testing or Inspection
Destructive reconstitution, dilution, transfer, clearing, solubilizing, filtration, screening, or sieving that allows a product to be visually examined or evaluated microscopically to determine the presence, type, and size of foreign particulate contamination present within the product, container, or device. (TR79)
Source:
Semiautomated Inspection
Consists of machine-assisted handling and presentation of filled containers to allow for human visual inspection. (TR79)
Source:
Probability of Detection
The likelihood of detecting a defective unit during an inspection process expressed as a probability, quantitatively as a number (0–1) or as a percentage (0–100%). (TR79)
Source:
Powders
Powders are defined as a solid or a mixture of solids in a finely divided state intended for internal or external use. Powders used as pharmaceutical dosage forms may contain one or more APIs and can be mixed with water for oral administration or injection. (TR79)
Source:
Manual Baseline
Data generated from visual inspection of a blinded set of seeded test containers that demonstrates the detection capability of human inspection. The test set is sometimes referred to as a “particle size threshold set,” where various foreign particulate types in a gradation of sizes are examined to yield a statistically significant probability of detection percentage for each unit. This allows the determination of what types and sizes of particulates can be reproducibly detected in a specific product/container system. (TR79)
Source:
Implants
Implants are long-acting dosage forms that provide continuous release of an API for periods of months to years. They are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or, for local delivery, they can be placed in a specific region in the body. (TR79)
Source:
Automated Inspection
Consists of mechanical handling and presentation of product containers combined with automated inspection of the filled containers using image analysis and/or light obscuration. (TR79)
Source:
Lot or Batch
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits.(TR76)
Source:
Warning Letters
Type of correspondence that notifies a regulated industry about violations that FDA has documented during its inspections or investigations. (TR67)
Source:
Significant Body of Information
A significant body of information on the stability of the drug product is likely to exist after 5 years of commercial experience for new molecular entities, or 3 years of commercial experience for new dosage forms (TR38)
Source:
Reportable result
The final analytical result. This result is defined in the written approved test method and derived from one full execution of that method, starting from the original sample. (TR57)
Source:
Reserve/Reference Samples
An appropriately identified reserve sample that is representative of each lot of intermediate product and in each shipment of each active ingredient shall be retained (at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications; this is a regulatory Requirement). (TR56)
Source:
Method Comparability
The demonstration of analytical method comparability (AMC) for method replacements. A study to demonstrate that a modification to an existing method either improves or does not significantly change the analytical procedure’s characteristics relative to the methods’ validation and intended use. (TR57)
Source:
Material Safety Data Sheet (MSDS)
Information provided with chemicals and other materials intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner. Includes information such as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill-handling procedures. (TR65)
Source:
Justification
Reports containing scientific data and expert professional judgment to substantiate decisions. (TR38)
Source:
ISO/IEC
International Organization for Standardization/International Electrotechnical Commision. (TR52)
Source:
Incident Management System
Part of the Quality Management System that handles incidents, deviations, excursions, and exceptions in the supply chain. (TR58)
Source:
Incident
Any event that occurs during the shelf life of a product that may have an adverse effect on quality (e.g., temperature excursion, missing temperature monitor when required, shipment time in excess of qualified packout duration, wet/ crushed packaging). (TR58)
Source:
Incoming Inspection
A preventative program where parts or products are subjected to evaluation upon receipt.(TR43)
A program where, upon receipt, parts or products are subjected to measuring, examining, testing, or gauging one or more characteristics of a product or service, and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.(TR 76)
Source:
Historical Data
For purposes of this guidance, data on impurities or physical attributes from three or more consecutive, representative pre-modification batches. (TR38)
Source:
Fault Tree Analysis (FTA)
A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)
Source:
FDA Form 483
Inspectional observation sheet used by FDA investigators to document their findings. (TR67)
Source:
Extemporaneous Preparation (EP)
A type of compounding whereby a drug or combination of drugs and/or excipients is prepared under the supervision of a pharmacist to create a customized medication dosage form in accordance with a clinical protocol. (TR63)
Source:
Decision Maker(s)
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.(TR54) (TR54-2)
Source:
Corrective Action and Preventative Action (CAPA)
Action 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. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5)
A subsystem used to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective measures to prevent recurrence of the identified problem (8). (TR88)
Source:
Commissioning
A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases:
1. Inspection, testing, and regulation
2. Adjustment and setting of work
3. Functional testing (TR 3)
A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48)
A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)
Source:
Comparative Transfer
Transfer of a method that involves the analysis of a predetermined number of samples of the same lot by both the sending and the receiving unit. (TR 57-2)
Source:
Compatibility
Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26) A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)
Source:
Class II Recall
A situation in which use of or exposure to a violative product or may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.(TR55)
Source:
Compendial Procedure
A method that is considered validated as published in one of the recognized compendia. (TR57)
Source:
Cleaning Validation
Documented evidence with a high degree of assurance that a cleaning process will result in products meeting their predetermined quality attributes throughout its life cycle. (TR29)(TR49)
Source:
Clean(liness)
The measurement for the level of particulates, microbes, or other extraneous substances on an item or surface. (TR 70)
Source:
Comparability Study
An assessment of the similarities between the critical parameters and output results of two or more separate processes or methods. (TR50)
Source:
Clean in Place (CIP)
The process of rinsing or washing of process components, as installed without removal, in order to remove or eliminate any contaminants. (TR45)
Source:
Clinician
A physician, psychiatrist, etc., who specializes in clinical work as opposed to one engaged in laboratory or experimental studies. (TR58)
Source:
Comparability Protocol
A protocol submitted by an applicant under CFR 601.12(e) and 314.70 (g) that describes the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, and potency of the product as they may relate to the safety or effectiveness of the product. Any such protocols, or change to a protocol, shall be submitted as a supplement requiring approval from FDA prior to distribution of the product. The supplement, if approved, may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect. (TR38)
Source:
Cleaning Verification
A one-time sampling and testing to ensure that specified equipment has been properly cleaned following a specific cleaning event. (TR29) (TR49)
Source:
Clean
Having product residues, process residues, and environmental contaminants removed to an acceptable level. (TR29) (TR49) The implementation of procedures to render an area, piece of equipment, system, or object free of adulterants and contaminants. (TR 70)
Source:
Complaint Files
(a) As defined by 21 CFR Part 211.198- Complaint Files. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. 1.The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant .2.Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180. (TR55)
Source:
