# What is Good Manufacturing Practice?

> The term Good Manufacturing Practice (GMP) covers various guidelines for production processes and environments.

- Source: https://info-pharma.de/en/gmp/
- Language: English (UK)
- Last updated: 2023-07-24
- Section: Home › Regulatory Requirements › GMP
- Deutsche Fassung: https://info-pharma.de/gmp/index.html.md

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## Definition of the term

The term **Good Manufacturing Practice** (**GMP**) covers various guidelines for production processes and environments. These specific [**regulatory requirements**](https://info-pharma.de/en/regulatorische-anforderungen/) serve quality assurance in the context of the production of **medicines**, active substances and foodstuffs. Assuring quality plays a decisive role, particularly in the manufacture of [pharmaceutical](https://info-pharma.de/en/pharmazie/) and [biotechnological](https://info-pharma.de/en/biotech/) products. Deviations can have a direct impact on consumers' health. To guarantee product quality and ensure that the regulatory requirements are met, GMP-compliant quality assurance systems and additional **document management systems** are frequently used.[1]

## Who draws up the GMP guidelines?

As with [**Good Laboratory Practice**](https://info-pharma.de/en/glp/), the guidelines of **Good Manufacturing Practice** are drafted by several bodies. These include, among others, the European Commission, the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the US Food and Drug Administration (FDA) and, at global level, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).[2]

## Elements of a GMP-compliant quality management system

A **quality management system**[3] designed in line with GMP guidelines should contain the following elements:

- **Document management** for controlled documents and records.
- Deviation management: processes, procedures and methods are described in controlled documents. Unplanned deviations from the GMP guidelines must be documented and assessed.
- Change management: specific changes to procedures or processes must be justified, planned and approved by quality assurance before implementation.
- Qualification of equipment: in a planned and documented process, the equipment must be shown to be suitable for the specific requirements and intended purposes.
- Validation of processes and methods: in a planned and documented process, processes and methods must be shown to deliver reliably reproducible results in accordance with the requirements.
- Staff training: employees must be trained in the relevant areas before starting their work, and this training must be documented.
- Risk management
- Internal audits

## Special document management systems for pharmaceutical and biotech companies

To meet the specific requirements of the **GMP guidelines** in the context of document management, external software is frequently used. These special **document management systems** are explicitly designed for the high demands of this industry. With the help of suitable software, complex work processes can be simplified, contributing to a smooth workflow. The resulting savings in time and resources ensure the highest possible efficiency.[4]

## Sources

[1] Gengenbach, Ralf. 2012. GMP-Qualifizierung und Validierung von Wirkstoffanlagen: Ein Leitfaden fur die Praxis. Weinheim: Wiley-VCH Verlag.

[2] Pisano, Douglas J. 2017. Essentials of pharmacy law. London, England: Routledge.

[3] Gamp good practice guide: Validation of laboratory computerized systems. 2005. International Society of Pharmaceutical Engineering.

[4] Gamp good practice guide: Validation of laboratory computerized systems. 2005. International Society of Pharmaceutical Engineering.