The Good Automated Manufacturing Practice (GAMP) Forum was founded in 1991 by pharmaceutical industry professionals in the United Kingdom to address the industry’s need to improve comprehension and evolving expectations of regulatory agencies in Europe.
Good Automated Manufacturing Process or GAMP is a set of guidelines for manufacturers and operators of automated systems within the pharmaceutical industry. Therefore GAMP is effectively is effectively a diversification of Good Distribution Practice for the pharmaceutical automated manufacturing sector.
The Good Automated Manufacturing Process Community Of Practice (GAMP COP) is a subcommittee of the International Society for Pharmaceutical Engineering (ISPE). GAMP COP evolved from the Pharmaceutical Industry Computer Systems Validation Forum (PICSVF). The initial GAMP guidance was published in 1994, GAMP5® is the 5th and most current form and was published in February 2008.
The objective of GAMP COP is to engage in instrument validation from a software perspective. The organisation believes that a quality control system must be built into each stage of the manufacturing process. It is believed that batch testing is inadequate. GAMP COP aims to promote the understanding of the regulation and the use of automated systems.
GAMP5® guidance is circulated to allow companies to produce: “Documented evidence, which provides a high degree of assurance that all parts of a system will consistently work correctly when brought online”.
The quality assurance process consists of three main elements:
This process confirms complete documentation. This includes the checking of purchase orders, proper hardware installation and software verification according to the original manufacturer’s specifications. Both the user and the supplier share a primary testing responsibility in this situation.
This procedure confirms the system operations by testing the design requirements which are traced back to the function specifications. This incorporates software and hardware functions under normal load, as well as under realistic stress. This is vital to ensuring whether the systems will work in a demanding environment. Here the primary testing responsibility again lies equally with the supplier and the user.
This practice is designed to confirm that a system is capable of performing the required activities whilst operating in a specific environment. A series of checks are made by the user against the original requirement specifications. In this case the responsibility lies solely on the user.
GAMP testing is a software focused approach. Infrastructure is qualified but not validated, rather the validation is performed on the hosted application and not the hardware. Infrastructure should be built, configured and deployed according to procedures outlined by the original manufacturer.
Each test will comprise of the assessment of the following categories applying to the earlier qualification processes:
- Backup and Restore
- Disaster Recovery
- Audit Trail
- Record Retention
Companies can benefit tremendously by following a GAMP5® framework to ensure their high quality goods are recognised internationally. This process can be made simple by incorporating the systems offered by Seven Telematics. The products available will ensure that the medicines’ environment can be managed effortlessly throughout the transportation process. This data can be fed to a remote location, or the driver in the cab.
The Transcan® temperature recording package will play a crucial role when maintaining a constant information stream to ensure the mandatory environmental conditions are maintained. The Transcan® will store information for up to two years before the data is overwritten. This wealth of information will enable your company to fulfil the information gathering requirements of GAMP5®. The tamper-proof nature of the temperature and data recorders will ensure that the data is secure, whilst also guaranteeing the reliability of the data collected.
This system can be combined with a variety of features such as the SevenEye system which is vital in ensuring a reliable audit trail is in place. This displays the Transcan® data of the entire fleet in a topographical or mapped format, allowing vital information to be digested with ease. The electronic storage of this data provides a sophisticated record of your fleet’s activities, whilst providing a secure audit trail.
GAMP5® recognition facilitated by Seven Telematics will ensure a reduction in the time and costs associated with achieving compliant systems. By following the GAMP5 framework, your company will become a forerunner in an industry with increased uniformity regarding validation testing.