Batch or Lot Number:
A unique identifier assigned to a production unit, which allows for traceability and tracking.

Batch Release:
The process of reviewing all production and quality control data to ensure that the batch meets established specifications before it can be sold or distributed.

Calibration:
The process of verifying that an instrument or device produces results within specified limits by comparison to those produced by a standard over an appropriate range of measurements.

Certificate of Analysis (CoA):
A document issued by Quality Assurance that confirms a regulated product meets its product specification. It includes the actual results obtained from testing performed as part of quality control of an individual batch of a product.

Change Control:
A systematic approach to managing all changes made to a product or system.

Corrective and Preventive Action (CAPA):
A method of finding and correcting minor issues before they become major ones, as well as identifying and preventing repeat issues.

Critical Quality Attributes (CQAs):
The physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality

Critical Process Parameters (CPPs):
Key variables affecting the production process that must be controlled within predetermined limits to ensure that a product meets its specification.

Design History File (DHF)
is a compilation of records which describes the design history of a finished device.The DHF can be either a collection of the actual documents generated in the product development (PD) process or an index of documents and their storage location.

Device History Record (DHR)
is a compilation of records that contains the production history of a finished medical device and ensures that the device is manufactured according to the Device Master Record (DMR) (How the recipe was executed)

Device Master Record (DMR)
is a comprehensive compilation of procedures and specifications for a medical device and includes everything from design specifications to packaging and labeling information. (Similar to a recipe)

Deviation:
Departure from an approved instruction or standard. (Can also referred to as a non conformance)

Environmental Monitoring:
The collection and analysis of data regarding environmental conditions, such as temperature, humidity, and particulate levels during manufacturing.

Good Manufacturing Practice (GMP):
Regulations that require manufacturers to ensure products are produced and controlled to quality standards. They cover all aspects of production, from the raw materials, premises, and equipment to the training and personal hygiene of staff.

In-Process Controls:
Checks and tests that are carried out before the manufacturing process is completed.

Master Batch Record (MBR) or Master Production and Control Records (MPCR):
The authorized, written procedure for a specific product and batch size, including detailed instructions and essential information for each stage of production and testing.

Material Safety Data Sheet (MSDS):
A document that contains information on the potential hazards (health, fire, reactivity, and environmental) and how to work safely with chemical products.

Quality Assurance (QA):
The maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

Quality Control (QC):
The operational techniques and activities used to fulfill requirements for quality, including measuring, examining, testing a product, and comparing the results with specified requirements to ensure conformity.

Reconciliation:
The process of comparing theoretical quantities (expected) with actual quantities for materials and components used in the batch to ensure that any discrepancies are within allowed tolerances.

Standard Operating Procedure (SOP):
A set of written instructions that document a routine or repetitive activity followed by an organization.

Validation:
Confirming that a process, system, material, method, product, piece of equipment, or personnel practice, if used as intended, will produce results that meet predetermined requirements.

Yield (Theoretical vs. Actual):
The quantity that is expected (theoretical) versus the quantity that is produced (actual) of a product.