Management Review

A documented review by the Top Management to assure the quality management system continues to be suitable, adequate, and effective, including stated policies and objectives related to the fulfillment of the organizations objectives.


Various operations, such as processing, packaging, labeling, and testing.

Margin of Safety

An indicator of the magnitude of the difference between an exposed dose to a human population and the highest no observed adverse effect dose determined in test animals. [7]

Marketing Authorization (Product License, Registration Certificate)

A legal document issued by the competent drug regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life. [20]

Mass Balance

The sum of the quantifiable material present in the excipient. [5]

Master Batch Record

Documentation of the steps necessary to produce a finished excipient by batch processing. [4]

Master Formula

Documents specifying the materials to be used along with their quantities, the packaging materials, and a description of the procedures and precautions required to produce a specified quantity of a finished product.

Master Process Flow

Documentation that describes excipient manufacture from raw material to final purification using continuous processing. [4]

Master Process Log

Record of the operating conditions used for the manufacture of the excipient using continuous processing. [4]

Master Production Instruction (Master Production and Control Record)

Documentation that describes the manufacture of the excipient from raw materials to completion. [1]

Master Production Record

Record of the manufacture of the lot/batch of the excipient from raw material to completion using batch manufacturing methodology.

Master Record

A document or set of documents that serve as a basis for the batch documentation (blank batch record). [20]


A general term used to denote raw materials (starting materials, reagents and solvents), process aids, intermediates, excipients, packaging and labeling materials. [1, 2, 3]


The design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations is tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations is tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and, possibly in some cases, different container closure systems. [13]

Mineral Based

Contains starting materials of mineral origin. [6]

Mixed Excipient

A mixed excipient is defined as a simple physical mixture of two or more compendial or non-compendial excipients produced by means of a low- to medium-shear process where the individual components are mixed but remain as discrete chemical entities, i.e. the nature of the components is not chemically changed.


Products resulting from the physical combination of multiple excipients, often through a mixing operation and the nature of the processing is such that the materials are not co-processed together. [7]

Model Product

A product that represents a group of similar products with respect to composition, functionality or specification. [1]

Modified Release

Dosage forms whose drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as a solution or an immediate release dosage form. Modified release solid oral dosage forms include both delayed and extended release drug products. [12]

Mother Liquor

The residual liquid that remains after crystallization or isolation processes. [1]


Material Safety Data Sheet [6]