NSF IPEC ANSI 363-2019 pdf free download – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
3 Definitions
Terms used in this Standard,which have a specific technical meaning, are defined here.
3.1active pharmaceutical ingredient(APl): Any substance or mixture of substances intended to beused in the manufacture of a drug product that, when used in the production of a drug, becomes an activeingredient of the drug product.Such substances are intended to furnish pharmacological activity or otherdirect effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure,or any function of the body of man or animals.
3.2adequate: Sufficient, although not necessarily the most or the best.
3.3appropriate: A quality of being suitable for assuring conformance to the requirements.
3.4archival system: System used to preserve information considered valuable,using media suitablefor storage and retrieval.
3.5backup: A copy of one or more electronic files created as an alternative in case the original data orsystem are lost or become unusable,and which is maintained securely throughout the record retentionperiod.
NOTE—Backups of electronic records are required because data loss (e.g., through deletion or corruption)during the record retention period is, historically , a common experience compared to paper records.
3.6batch: A specific quantity of material produced in a process or a series of processes so that it maybe expected to be uniform in character and quality,within specified limits. In the case of a continuousprocess, a batch may correspond to a defined fraction of the production. The batch size may be defined bya fixed quantity or by the amount produced in a fixed time interval.
3.7calibration: The demonstration that a particular instrument or measuring device produces resultswithin specitied limits by comparison with results produced by using a reference or traceable standard, overan appropriate range of measurements.
3.8certificate of analysis(COA): A document listing the test methods, specifications, and results oftesting a representative sample from the batch to be delivered.
3.9certificate of conformity (CoC): A document that confirms the product shipped to the customercomplies with a specific set of requirements or specifications. It does not contain actual test results,
3.10change control: A process used for management review of proposed changes that may impactthe quality or regulatory conformance of the excipient.
3.11competency: The demonstrated personal attributes and ability to apply knowledge and skills.3.12component:Any material present in the excipient that arises as a consequence of the rawmaterials and/or manufacturing process.
3.13computer system: A group of hardware components and associated software designed andassembled to perform a specific function or group of functions.
3.14contaminant: An undesired material of a chemical or microbiological nature, or foreign matterintroduced from a raw material, intermediate, or excipient during production, sampling, packaging, storageor transport.
3.15 contamination: The undesired introduction of impurities of a chemical or microbiological nature,or foreign matter into or onto a raw material, intermediate, or excipient during production, sampling, packaging or repackaging, storage, or transport.
3.16 continual improvement: Recurring activity to increase the ability to fulfill requirements.
3.17 continuous process: A process that continually produces material from a continuing supply of raw material.
3.18 corrective action: The action taken to eliminate the cause of a detected nonconformity or other undesirable situation.NSF IPEC ANSI 363 pdf download.