Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

Importancia y uso:

4.1 Although some CM is used in the pharmaceutical industry (for example, purified water production), and some processes are inherently continuous individual unit operations (such as dry granulation and compression), these operations are generally operated in isolation and do not deliver the potential benefits of an integrated CM operation. The FDA Guidance for Industry PAT document specifically identifies that the introduction of continuous processing (now redefined as CM) may be one of the outcomes from the adoption of a science-based approach to process design.

4.2 This guide does not:

4.2.1 Suggest that CM is suitable for the manufacture of all pharmaceutical products.

4.2.2 Provide guidance on issues related to the safe operation of a CM process or continuous processing equipment. It is the responsibility of the user of this standard to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to use.

4.2.3 Recommend particular designs or operating regimes for CM.

4.3 Appendix X1 includes a table comparing the characteristics of continuous and discrete or batch processes.

Subcomité:

E55.11

Referida por:

E3326-22

Volúmen:

14.01

Número ICS:

11.120.01 (Pharmaceutics in general)

Palabras clave:

application; continuous manufacturing; pharmaceutical industry; process control;