Apart from the term facility, a range of other designations exist such as "machine", "apparatus" or "equipment". The EU GMP Guideline uses the term equipment which describes all cases where individual items, or items that are connected with one another, are used to manufacture, process or package pharmaceutical products through direct or indirect contact with one another. Equipment may be driven manually or mechanically. In the EU GMP Guideline, production machines, testing or control devices, as well as supply and disposal systems for air, water and other utilities, are also included under "equipment".
Information on supply and disposal systems can be found in the chapter on rooms and utilities (see chapter 3 Premises). The following chapters focus on the category of mechanical and automated production and packaging machines. The specifications and information provided here may partially be applied to simple manual apparatus.
From the start of and throughout their entire service life, rooms and facilities must be designed, organised and assessed from the standpoint of the quality of medicinal products. To this end all data must be brought together in a comprehensive technical documentation: starting with the specification followed by the building and design documents, and then all changes made during production. Calibration (see chapter 4.G Calibration) and qualification (see chapter 6 Qualification) may also, similar to maintenance (see chapter 4.H Maintenance), only effectively perform their quality assurance functions if up-to-date technical documentation is used as the basis (see chapter 4.F Technical documentation).
In addition to the technical performance data, specifications for facilities in the pharmaceutical production and packaging sectors must always take the special requirements of the GMP regulations into account. General requirements of the EU GMP Guideline for equipment may be found in the guidelines (Article 8) and in chapter 3.34 onwards
Figure 1 Requirements for equipment
Requirements for equipment
The equipment ...
- ... must be suitable for the intended purpose
- ... must be maintained
- ... must be qualified
- ... must be easy to clean
- ... must not cause any undesirable interaction with the product
- ... must not damage the product
- ... must be installed correctly
- ... must be calibrated
Using the above basic rules, individual specifications, known as user requirements, may be derived for all machines. Together with the technical specification from the supplier and the order documents, these are part of the design qualification (DQ). (See chapter 1 Design qualification.)
Apparatus or facilities are constructed using a range of components. In order to be able to assess and quantify the quality of a facility, its individual components must be initially considered in the installation qualification (IQ) (see chapter 2 Installation qualification). The interaction of components is then tested in the operational qualification (OQ) (see chapter 3 Operational qualification) and the effect on the product is tested in the performance qualification (PQ). As quality cannot be tested in the facility itself afterwards, it is expedient from the outset to refer to individual components in the specification phase (DQ).
Machines can generally be classified into two main components: a machine essentially consists of the mechanical part (see chapter 4.B Mechanical components) that is driven electrically or pneumatically, and the control (see chapter 4.C Control). From the point of view of quality assurance, machine controls have a greater significance, as their scope and complexity is always increasing. Special facility designs (see chapter 4.D Facility concepts) that are the result of ongoing further development of GMP ideas (such as Cleaning in Place) are described in a separate chapter.