Browse Definitions :
Definition

good automated manufacturing practice (GAMP)

Good automated manufacturing practice (GAMP) is a set of guidelines for manufacturers and other automation users follow to maintain operational efficiency and reliability. GAMP is also a subcommittee of the International Society for Pharmaceutical Engineering (ISPE).

GAMP guidelines are used heavily by the pharmaceutical industry to ensure that drugs are manufactured with the required quality. GAMP COP (Community of Practice) is a pharmaceutical professionals’ forum that ensures continued development and adoption of best practices in the field.

Rather than testing quality control batches, GAMP makes quality testing an integral part of each stage of manufacturing, including facilities, equipment, materials acquisition and staff hygiene. This rigorous employment of standard of operating procedures (SOP) helps ensure purity of manufactured pharmaceuticals.

GAMP publications include practice guides on calibration management, compliance, IT infrastructure, data archiving and process validation. One of the most guidance documents is GAMP 5 Guide: Compliant GxP Computerized Systems, which is often simply referred to as GAMP 5. The document provides an outline for the application of risk management principles and tools for computer system validation.

GAMP was created in 1991 in the United Kingdom to address the pharmaceutical industry’s desire to create guidelines that would improve understanding of changing expectations of regulatory agencies in Europe. This included improved working relationships with agencies in other countries like the United States Food and Drug Administration (FDA). GAMP also sought to encourage understanding of how computer systems validation should be handled in the pharmaceutical industry. Since its creation, the standards organization has become a recognized creator of good practice worldwide.

This was last updated in September 2018

Continue Reading About good automated manufacturing practice (GAMP)

SearchCompliance
  • pure risk

    Pure risk refers to risks that are beyond human control and result in a loss or no loss with no possibility of financial gain.

  • risk reporting

    Risk reporting is a method of identifying risks tied to or potentially impacting an organization's business processes.

  • risk avoidance

    Risk avoidance is the elimination of hazards, activities and exposures that can negatively affect an organization and its assets.

SearchSecurity
  • script kiddie

    Script kiddie is a derogative term that computer hackers coined to refer to immature, but often just as dangerous, exploiters of ...

  • cipher

    In cryptography, a cipher is an algorithm for encrypting and decrypting data.

  • What is risk analysis?

    Risk analysis is the process of identifying and analyzing potential issues that could negatively impact key business initiatives ...

SearchHealthIT
SearchDisasterRecovery
  • What is risk mitigation?

    Risk mitigation is a strategy to prepare for and lessen the effects of threats faced by a business.

  • fault-tolerant

    Fault-tolerant technology is a capability of a computer system, electronic system or network to deliver uninterrupted service, ...

  • synchronous replication

    Synchronous replication is the process of copying data over a storage area network, local area network or wide area network so ...

SearchStorage
  • gigabyte (GB)

    A gigabyte (GB) -- pronounced with two hard Gs -- is a unit of data storage capacity that is roughly equivalent to 1 billion ...

  • MRAM (magnetoresistive random access memory)

    MRAM (magnetoresistive random access memory) is a method of storing data bits using magnetic states instead of the electrical ...

  • storage volume

    A storage volume is an identifiable unit of data storage. It can be a removable hard disk, but it does not have to be a unit that...

Close