GAMP 5 guidelines

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 formed in 1991 in the United Kingdom for the purpose of dealing with current US regulations to obtain appropriate manufacturing practices in the manufacture of pharmaceutical products.

The original GAMP guidelines were published in 1994, but then the group joined the International Society for Pharmaceutical Engineering and officially joined the association in 2000., Europe and South Asia. Today, it has been adopted as one of the most important guidelines for good practice for pharmaceutical manufacturers worldwide.

The purpose of this group is to establish recommendations for drug manufacturers as well as those using automated medicine manufacturing systems. It is a set of guidelines and techniques aimed at ensuring that the pharmaceutical products manufactured by pharmaceutical manufacturers are of the required standard. The GAMP 5 framework, which is the latest comprehensive approach to certification of GxP automated systems, was promoted in 2008. Its goal is to offer an affordable system of best practices that ensures that automated systems are good enough to produce pharmaceuticals. high quality products and comply with the rules.

The key principles of GAMP 5 imply that it is not possible to test the top quality of the product within a production batch, but it must be embedded in every step of the manufacturing process. Thus, GAMP 5 takes care of every part of the manufacture of a pharmaceutical product, from how the raw ingredients are obtained, how the factory is built and tools for training and safety as well as the hygiene of its employees. Thus, GAMP 5 establishes standard procedures that are important for production steps that can affect the quality of the final product.

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

the GAMP 5 guidelines consists of 5 main concepts and this includes:

1. To have an excellent understanding of the product under production as well as the production process

2. Within the quality management system, GAMP-5 is interested in the life cycle approach

3. Scalable life cycle actions

4. Excellent risk management based on scientific principles.

5. Reducing the depth of suppliers’ commitment to the manufacturing process.

There are many uses of the GAMP 5 guidelines, some of which include:

1. Take a closer look at the environment in which medicines are manufactured, produced and stored in the pharmaceutical industry.

2. Observing the entire autoclaving process.

3. Monitoring the process of how the water is purified.

4. Monitoring of freeze drying