The pharmaceutical industry has the characteristic of being regulated.

Institutional bodies are therefore called upon to decide on the characteristics of production systems and their peripheral systems, which includes tertiary computer systems as long as they relate to data deemed critical. European regulation, centered on the European Directive 2003-94, is designed to be compatible with the laws of the United States contained in CFR 21 parts 210 and 211, through mutual recognition agreements, and piloted by The FDA. In this context, the compliance of the instal- lations with the expectations of the inspectors passes before respecting state of the rules art more than standards. The state of the art is synthesized in the GAMP (Good Automated Manufacturing Practice) currently in version 5. The GAMP is structured around a life cycle leading from the specification of an instalaltion to its validation, the production.

In France, the ANSM is based on Good Manufacturing Practices (which constitute a reference frame opposable to the inspections).

GMPs are based on 10 principles:

1. WRITE the procedures and instructions to provide a "roadmap" for GMP compliance and regular quality production.
2. FOLLOW scrupulously procedures and instructions to prevent contamination, inversion or error.
3. DOCUMENT early and accurately current work for procedural compliance and traceability.
4. PROVIDE that systems do what they are designed for by formal validation.
5. INTEGRATE productivity, product quality and safety of personnel in the design of buildings and equipment.
6. PERFORM MAINTENANCE of buildings and equipment on a regular and efficient basis.
7. DEVELOP AND DEMONSTRATE clearly skills at the workplace.
8. PROTECT products against contamination by adopting regular and systematic habits of cleanliness and hygiene.
9. BUILDING QUALITY in products through control of raw materials and processes such as manufacturing, packaging, labeling ...
10. PLAN and perform AUDITS on a regular basis to ensure GMP compliance and quality system effectiveness

And the concept of 5 M:

• Equipment (identified, maintained, cleaned, qualified ...)
• Methods (available, detailed, precise, verified, validated, audited ...)
• Workforce (trained and empowered at work)
• Materials (identified, controlled ...)
• Environment (qualified production infrastructure ...)