Nonconformity (ISO def.)
A condition of any product or component in which one or more characteristics do not conform to requirements. Includes failures, deficiencies, defects, and malfunctions. [Synonym: Defect](TR43)(TR76)
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Post-fill Inspection
Inspection of glass containers after product filling. (TR43)
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Sampling Plan
This indicates the number of units of product from each lot or batch which are to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR43)
The number of units of product from each lot or batch that need to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR 76)
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Sanitization
Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13) A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14) The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45) A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)
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Product Stream
The process flow in which a product is manufactured.(TR43)
The process flow in which a product is manufactured that is often described in a process map.(TR 76)
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Quality Specification System
A system that outlines the nonconformities, classifications and AQL’s. (TR43) (TR 76)
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Quality Risk Management (QRM)
A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68)
Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58)
A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)(TR88)
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Online Observations
Observations or findings that are found during the processing of a product or products. (TR43)
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Operating Characteristic Curves
The operating characteristic curve shows the probability of acceptance (Pa) for any level of lot quality. (TR43)
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Nonconformity Classifications
Critical: A Nonconformity that is likely to result in personal injury or potential hazard to the patient. This classification includes any nonconformity that compromises the integrity of the container, and risks microbiological contamination of a sterile product.
Major A: A Nonconformity leading to serious impairments, for example, a malfunction that makes the packaging unusable.
Major B: A Nonconformity leading to impairments of a lesser degree, for example, reduced efficiency in production.
Minor: A Nonconformity that does not impact product quality or process capability.
N/A: An imperfection classification that is less than the size, magnitude and impact of a nonconformity is considered not applicable. Therefore an imperfection that is considered to be non-applicable is acceptable.(TR43)
Critical: A nonconformity that risks personal injury or potential hazard to the patient. Any nonconformity that risks container closure in¬tegrity is assigned to this classification.
Major A: A nonconformity leading to serious container impairments, e.g., a malfunction making packaging unusable.
Major B: A nonconformity leading to contain¬er impairments of a lesser degree, e.g., reduced efficiency in production.
Minor: A nonconformity that does not impact product quality or process capability.
N/A: Imperfections that are considered to be nonapplicable or nondefects and are therefore acceptable.(TR 76)
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Nonconformity (ANSI def.)
A departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement. [Synonym: Defect] (TR43)(TR76)
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Limit Sample
An actual physical unit that is agreed to between the drug manufacturer and the glass manufacturer that defines the approximate maximum degree of acceptability for a specified non-conformance. Creation of limit samples between the user and the manufacturer is optional. (TR43)
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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)
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Defect
(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51) (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)
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Dimensional Product Quality
The product conforms to the required drawing dimensions. (TR43)(TR76)
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Attribute Sampling
Inspection where either the unit of product is classified as conforming or non-conforming or the number of non-conformities in the unit of products is counted with respect to a given requirement of set of requirements. (TR43)
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Acceptable Quality Limit (AQL)
The quality level that is the worst-tolerable process average when a continuing series of lots are submitted for acceptance sampling. (TR43) (TR 76)
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