GMP Glossary & Definitions

Maintenance:

The term maintenance is used for a system describing on how to maintain good working order facility, utility, equipment or instruments for their intended use. Maintenance is categorized in planned or preventative maintenance or breakdown maintenance or repair.

Management with executive responsibility:

Senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer´ s quality policy and quality system.

Manufacture, processing, packing, or holding:

All operations used to manufacture an API to include packaging and labeling operations, testing, and quality control of an API.

Manufacture:

The term manufacture also often referenced as manufacturing describes the complete cycle of manufacture of drug substance / Active Pharmaceutical Ingredient (API) or drug product from start of material purchasing till dispatch for sale or supply purchase of final rug substance / Active Pharmaceutical Ingredient (API) or drug product.

Manufacturer:

The manufacturer is the producer of the drug substance / Active Pharmaceutical Ingredient (API) or drug product.

Market:

The term market describes wholesalers or distributors outside the manufacturing site, governmental organisations, pharmacists, hospitals, doctors, patients and or external organisations to which the sites distributes the product.

Market withdrawal:

The removal or correction of a distributed product, which involves a minor violation which would not be subject to any legal action by the health authorities or which involves no violation (e.g. stock rotation practices).

 

Marketing Authorization Application (MAA):

The Marketing Authorization Application is the registration file submitted to the relevant national authorities of EU member states or the EMEA (European Medicines Evaluation Agency) as part of an application to market a new product in the European Union.

Master Manufacturing Record:

The Master Manufacturing Record is the comprehensive document describing the full manufacturing process for the manufacture of a drug substance or drug product. The process starts with the starting materials, their quantities, to be used, together with a description of the manufacturing operations including details of the In Process Controls (IPC).

Master Validation Plan:

Please refer to Validation Master Plan

Material:

The term material is used for either raw materials, intermediates or packaging components used in the manufacture of drug substance / Active Pharmaceutical Ingredients (API) and drug products.

Medical Device:

FDA, Federal Food, Drug, and Cosmetic Act, 21:

http://www.fda.gov/cdrh/devadvice/312.html#link_2
European Definition: DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007, which amended the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993

Method:

A method is a designed way of performing a process, a check-up or a test which must be normally validated under GMP conditions.

Medicines & Healthcare Products Regulatory Agency (MHRA):

The UK licensing authority for pharmaceutical products and medical devices

Mother liquor:

The residual saturated liquid that remains after crystallization. A mother liquor may contain unrecovered or unreacted starting materials, intermediates, the API and/or impurities

Mock Recall:

A mock recall is called a simulation of a recall inside a site or company. 
The intend is to verify the effectiveness of the internal steps in the recall procedure except the notification of any regulatory agency.

Monitor:

The term monitoring is frequently used in the context of carrying out repeated measurements or observations of one or more characteristics of a product, process or environment. Monitoring, continuous or intermittent is used to assure that the above mentioned processes are performed as intended.