What is Good Manufacturing Practice?
Definition of the term
The term Good Manufacturing Practice (GMP) covers various guidelines for production processes and environments. These specific regulatory requirements 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 and biotechnological 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, 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 system3 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