Tailgate Sample
Representative and random samples of the lot taken by the manufacturer during the packing process for the use of incoming inspection purposes. (TR76)
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Supplier
The entity with whom the agreement of the quality level is made and the transaction of purchase is made; the last link in the chain of manufacturers and distributors. The supplier may be the manufacturer.(TR76)
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Sampling Plan True AQL
The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4.(TR76)
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Particulate Load
The total quantity of particles in solution as tested per qualified method. (TR76)
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Particles/Particulate (Intrinsic Particles)
Particles that arise from sources related to the materials of construction of the component. Examples of intrinsic particle materials include elastomeric particles of the same formulation or ingredients from elastomer for elastomeric components. (TR76)
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Particles/Particulate (Inherent Particles)
Particles that are expected from the drug formulation, and therefore not included as a category in this Lexicon.(TR76)
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Particles/Particulate (Extrinsic Particles)
Particles that are not part of the formulation but are foreign and unexpected. Examples of extrinsic particles include fibers (e.g., cellulous), clothing fragments, hair, foreign rubber (including degraded/reverted rubber of the same formulation), metal, plastic, and paint. Materials such as foreign rubber, metal, and plastic are defined as extrinsic in cases where the specific material identified is not a material of construction and therefore not considered part of the rubber formulation.(TR76)
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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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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)
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In-Process Observations
Observations or findings that are found during the processing of a product or products.(TR76)
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Defect (ISO def.)
The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR76)
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Defect (ANSI def.)
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. (TR76)
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Container Closure Integrity (CCI)
The ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards.(TR76)
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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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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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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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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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Dimensional Product Quality
The product conforms to the required drawing dimensions. (TR43)(TR76)
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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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