Gamp categories examples manual#
Gamp categories examples software#
Gamp categories examples professional#
Gamp categories examples series#

It manages data flows to and from the Machine Control and displays them on the monitor it also collects the data and statistics regarding product quality. The HMI software, on the other hand, is the means of communication between the machine and the operator. In the Prexima it is installed on a PC, while in the Mylab it is installed on a PLC.

Gamp categories examples software#

The Machine Control software processes all machine movements, the phases, the data coming from the sensors and the specific functions of the machine. The software architectures of Prexima and Mylab are made up of two macro systems: Machine Control and User Interface, both designed and implemented in-house.

Gamp categories examples series#

In order that the software used in these machines can be classified as non-configured and belonging to Category 3, as suppliers we have had to carry out a series of activities, listed below.īefore carrying out the Risk Assessment, it was necessary to understand the context of application and make an in-depth study of the software architecture of the two machine models aim of the project.

It is a compact laboratory system, designed for R&D applications and for small product batches. Mylab is a multifunction system used to carry out granulation and/or core coating processes. Prexima is an automatic rotary tablet press for producing single layer tablets it has a gravimetric powder feeding system and allows all production volumes to be processed. The project focused on the software of IMA Active’s two latest machine models: Prexima and Mylab.

Gamp categories examples professional#

The process involved the collaboration of various professional figures, including members of the Quality Assurance Department, software engineers, validation and Risk Assessment experts, co-workers from research laboratories and University of Bologna, as shown in Figure 1. In the development of the latest machine models (Prexima and Mylab), particular attention has therefore been paid to software design and a multi-phase project has been devised, including Risk Assessment and Control, which is described in this article.

Gamp categories examples manual#

Given the growing level of automation, functions and processes previously managed by mainly mechanical devices are now carried out with the aid of software components, which therefore take on increasing importance, as the aim is to guarantee the quality of products and process control even where a computerized system takes the place of a manual operation. As automatic machine supplier operating in the pharmaceutical sector, IMA Active develops its own equipment according to GAMP ® 5 principles and framework. In particular, GAMP ® 5 (“A Risk-Based Approach to Compliant GxP Computerized Systems”) guidelines introduce the concept of Risk Management for automated and computerised systems, aimed at focusing validation and control only where really necessary, identifying the functions and processes that are most at risk for the pharmaceutical product. Of the reference standards and methods, the GAMP ® (Good Automated Manufacturing Practices) guidelines have the purpose to interpret the validation requirements and apply them to all aspects linked either directly or indirectly to pharmaceutical product quality. In order to put on the market products that meet the requirements of the Customers, IMA Active must always be conscious of the requirements issued by the regulatory authorities to ensure all critical equipment is capable of being implemented to meet validation requirements and thus ensuring patients safety, product quality and data integrity. IMA Active division, one of the Group’s three pharmaceutical brands, is specialized in the design and manufacturing of machines and systems for processing and manufacturing of oral solid products. The Group’s organisational structure is based on the production and commercial divisions that make up the business: IMA Pharma (processing and packaging in the pharmaceutical sector), IMA Dairy & Food (packaging in the food sector), Extra Pharma companies (packaging of tea, herbal infusions, coffee, drinks, cosmetics and toiletries). is the world leader in the design and production of automatic machines for the processing and packaging of pharmaceuticals, cosmetics, food, tea and coffee. Founded in 1961 in Bologna (Italy), I.M.A.