Gamp 5

GAMP 5 guideline

The GAMP guidelines relate to the Regulated company and their good manufacturing practices, the responsibility for full compliance of relevant standards ultimately stops there. In GAMP 5 however greater importance has been placed on Supplier Leverage, that is the supplier of a product or service should be aware of the guidelines and adhere to them, this has the effect that Regulated companies can use the suppliers documentation, testing, verification, and quality plan, to prove compliance to regulation authorities. This puts more responsibility to the supplier, and reduces the amount of duplication the Regulated company needs to carry in order to have a compliant system to the required standards. The key driver behind the evolution of the GAMP guidelines from GAMP 4 to GAMP 5 is to focus attention on patient safety, product quality and data integrity, through categorizing computer systems by risk, novelty & complexity. There is a need to avoid duplication by integrating engineering activities with computer system activities, and to leverage supplier activities whilst ensuring fitness for intended use. The aim is not to restrict but to aid innovation.

About ISPE

Founded in 1980, the International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit industry trade group for pharmaceutical science and manufacturing professionals, and has 25,000 members in more than 90 countries.

ISPE aims to be the catalyst for pharmaceutical innovation by providing pharmaceutical industry professionals with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore.
ISPE offers access to industry-standard technical documents, peer-reviewed publications, industry and regulatory resources, relevant continuing education and training, and the first competency-based international certification for pharmaceutical professionals. And is the drive behind the GAMP guides.
GAMP applies to Healthcare industries who produce pharmaceutical, biotechnology & medical devices fall under the embrace of the GAMP guidelines.
The ISPE is an international organization, the GAMP documents are a guide to progress good manufacturing practices world wide. Because the GAMP guidelines are not a standard a company cannot be Certified, Compliant or ApprovedActivity to gain more understanding of healthcare automated manufacturing started in the late 80’s and early 90’s, when greater validation of the pharmaceutical industries was becoming necessary as automated systems played a greater role in healthcare production.
The first GAMP guidelines were put into action in March 1994. January 2008 being the latest release of the GAMP 5 guidelines.
The GAMP guide has been updated to keep up with concepts and regulatory & industry developments.
• Avoid duplication of activities, fully integrate engineering and computer system activities so that they are only performed once.
• Leverage supplier activities to the maximum possible extent, while still ensuring fitness for intended use.
• Scale all life cycle activities and associated documentation according to risk, complexity, and novelty; e.g. If the system uses non-configured off the shelf software, complexity, novelty and risk is therefore low. If the system uses programmed software designed specifically for the application, the novelty, complexity and risk is high.

A comparison between FDA and GAMP guidelines

GAMP focuses on the whole system and the end product, where as the FDA focuses on each process and stage of production that contributes to the end product. FDA guidances are incorporated into the GAMP guidelines.
As the GAMP 5 guidelines have "Automated" built into the name and their philosophy—they envision process and system (computer) validation as integrated entities. An automated process is tested as an installation, operational, and performance qualification to be certain that the automated procedure has been properly installed, tested, and used. By contrast, the FDA's GMP document assumes a manual process with reference to the reality of automated process systems through the separate document 21 CFR Part 11, which defines system validation and provides guidelines for it. The GAMP stresses bottom-line performance, while the FDA stresses the process itself (procedurally and with automation). Under GAMP 5, an investigator would validate the results of an automated analysis system as a functioning analytical unit. Under GMP, an investigator would validate the analytical process of each step of the process.
Similarly, the GAMP focuses on quality assurance (QA). While still emphasizing QA, the FDA approach puts equal weight on the quality control (QC) process, including all aspects of production and operation as well as the final QA overview.
The result is, the FDA has a greater reliance on analysis at all phases, where GAMP has reliance on the final result rather than the interim steps that lead to that result. In short, process understanding (FDA) versus process outcome (GAMP).