GAMP 5 Guidelines

The GAMP, which is an abbreviation for Good Automated Manufacturing Practice refers to a technical policy group within the International Society for Pharmaceutical Engineering. The group was put together in 1991 in the UK with the aim of handling the existing United States regulations for achieving appropriate production practices in the manufacturing of pharmaceutical products.

The initial guidelines of GAMP were published in 1994, but after that, the group went into association with the International Society for Pharmaceutical Engineering and was officially absorbed into the association in 2000.Over the years, GAMP has been accepted by several regulatory agencies in America, Europe and South Asia. Today, it has been adopted as one of the most important good practice guidelines for manufacturers of pharmaceutical products worldwide.

The aim of this group is to lay down recommendations for drug manufacturers as well as those who use automated systems to make drugs. It is a set of guidelines and techniques aimed at ensuring that the pharmaceutical products made by drug manufacturers are of the required standard. The GAMP 5 framework which is the most recent, comprehensive approach to the certification of GxP automated systems was brought forward in 2008. Its objective is to offer an affordable system of proper practice that makes sure that automated systems are good enough for producing quality pharmaceutical products as well as complies with regulations.

The major principles of GAMP 5 entail that it is not possible to test the excellence of a product within a production batch, but it has to be embedded into every step of the manufacturing process. By so doing, the GAMP 5 take care of every part of manufacturing a pharmaceutical product, from how the raw ingredients are sourced, how the manufacturing facility is built and tools to the training and safety as well as hygiene of its employees. The GAMP 5 thus lays down standard operating procedures which are important for the production steps that can influence the quality of the final product.

According to GAMP, it should be noted that GAMP 5 is not meant to be a prescriptive technique or procedure, but it is meant to offer careful guidelines, techniques and methodologies for the manufacturers in the pharmaceutical industry as well as those who use automated systems. What this entails is that manufacturing companies must utilize these guidelines together with sister recommendations to come up with the best method for certifying GxP computerized systems. The guidelines provided by the GAMP 5 go as far as showing the specification, features, as well as the certification process.

The GAMP 5 guidelines are made up of 5 major concepts, and this includes:

1. Having an excellent comprehension of the product under production as well as the process of production

2. Within the Quality Management system, the GAMP-5 is interested in the lifecycle approach

3. Lifecycle actions which are scalable

4. Excellent management of risk that is based on scientific principles.

5. Reducing the depth of involvement from the suppliers in the manufacturing process.

There are many applications of the GAMP 5 guidelines and some of them include:

1. Taking a closer look at the environment where medications are manufactured, produced and stored within the pharmaceutical industry.

2. Observing the entire process of autoclaving.

3. Monitoring the process of how water is purified.

4. Monitoring the process of freeze drying

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