Glossary of Terms

allocated reserved portion of inventory, designated for specific batches archived materials, documents, or data stored and filed for future reference audit trail a systematic record of all actions related to a process or item, providing evidence of integrity and authenticity attribute a specific quality or characteristic of a product or component available products or materials ready for use or sale batch a specific quantity of a product processed or produced at one time batch # unique identifier assigned to a particular batch or production run batch id unique identifier assigned to a particular batch or production run bill of materials (bom) a comprehensive inventory of the raw materials, assemblies, and quantities needed to manufacture a product capa corrective action and preventive action; procedures that correct errors and are designed to prevent the recurrence of product or process defects cgmp current good manufacturing practice; regulations enforced by the fda, ensuring that products are consistently produced and controlled according to quality standards customer approved verification that a product/formula meets a customer's specifications and requirements deviation a departure from standard procedures or specifications, often requiring investigation and documentation fifo fifo stands for first in, first out this means the first items received will be the first used formula a specific list of ingredients and packaging for producing a particular product gmp good manufacturing practice; guidelines that govern the manufacturing, testing, and quality assurance of drugs and food in stock products or materials present in inventory lot a batch or segment of a production run or received material, identified by a unique number for tracking material request a formal request for specific materials to be delivered master manufacturing record (mmr) a document that contains the instructions for the production and packaging of a finished product metrics measurements or statistics used as a standard of performance mixed products or materials that have been combined or blended non conformance failure of a unit or batch to meet specified criteria or standards on hold items that are not to be used, sold, or moved until a specified condition is met ordered products or materials requested for purchase and waiting to be received par level a minimum quantity of a product that must be on hand to ensure uninterrupted service purchase order a document issued by a buyer to a seller, indicating the types, quantities, and agreed prices for products qc approved formulas that have been approved by the quality control department quality assurance (qa) the systematic process of ensuring products meet the established standards of quality quality control (qc) the process of verifying that a product meets required specifications and standards quality event an occurrence which causes a product or process to deviate from accepted standards or specifications quarantined products or materials isolated for quality review or safety reasons, often pending inspection or decision on their use reports excel downloads that summarise data, metrics, and events retains samples of materials or products kept for testing or as a reference for future use sales order a document confirming a sale, detailing the buyer, product, quantity, and price agreed upon between manufacturer and customer sections distinct steps within a document or process sku stock keeping unit; a unique identifier for each distinct product or component that can be used or sold sop standard operating procedure; a set of step by step instructions to help workers carry out complex routine operations specification detailed description of the requirements and quality standards for a specific component or product split lot a portion of a lot that is separated from the main lot for specific reasons templates pre designed forms and workflows used as a starting point for new mmrs unique id a unique identifier used to represent a specific item, usually used for traceability usable formulas that have all skus attached with units selected and are fit for intended use