Glossary of Terms

1min
  • 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.