GAMP Traceability from powder to pil

GAMP  Traceability from powder to pil

GAMP – Traceability from powder to pill

The increasingly stringent regulations relating to production within the food and pharmaceuticals industries have led to the requirement for automated systems to be designed and implemented according to a set, traceable and verifiable process. Terms such as tracking and tracing are not unknown to pharmaceutical and food production companies. A producer needs to be able to demonstrate which ingredients have been incorporated into a certain batch of product and in what quantities, as well as who the supplier of those ingredients was. Furthermore, it must be possible to determine who is responsible for the realisation of a quantity of product, at what time, and subject to which production environment conditions. The FDA set down these requirements in the form of regulations and, in order to be able to satisfy the requirements, the (pharmaceutical) industry joined forces and developed GAMP “Good Automation Manufacturing Practices” and laid these down in a book.  

 

Important features include:

  • The GxP requirements are law. In order to be able to satisfy the FDA, a company must be able to provide reliable evidence.
  • It must be possible to demonstrate that products satisfy the requirements. Reproducibility of data (the demonstration) is of the utmost importance in this process. This means that the data must be stored on paper or electronically.
  • Traceability of design requirements and the selected solutions. The design requirements of the system must be recorded, along with the selected solution, so that it can be demonstrated that all requirements have been fulfilled (validation).
  • Validation and remaining validated is essential, including in relation to system maintenance.

GAMP gives direction and shape to the development process of an automated system and explicitly lays down the responsibilities of both the customer and contracting party.

On the basis of GAMP, the project is divided into phases using the so-called V-Model. This lists the documents to be produced and the responsibilities of the customer and contractor in each phase of the project. The requirements, specifications, design and construction phase are all concluded with a review of all of the documents produced (in that phase). A subsequent phase can only begin once the previous phase has been rounded off with a verification process.

This organisation of projects into phases is recorded within GAMP in the form of a V-model.



Within the V-model, one can discern a vertical line (the design phases) and a horizontal line (verification). There is a relationship between the documents on the one side and the developed software and hardware on the other. If the entire V-model is realised, this means that it must be possible to trace data between all of the individual steps.

Over the past few years, Moekotte has implemented a large number of projects on the basis of GAMP. In view of the fact that the above structure requires a certain method of working, a decision was taken by Moekotte to implement all projects in accordance with the V-model.