Standard Guide for Corrective Action and Preventive Action (CAPA) for the Cannabis Industry

Importancia y uso:

3.1 The ability to identify and respond to opportunities before issues become systemic or are a risk to consumer health and safety is vital to maintaining compliance and achieving consumer expectations. The CAPA process is a systematic approach for documenting, identifying, and correcting existing and potential quality issues from various data sources. The CAPA subsystem analyzes and trends data inputs from quality systems and processes to identify if a quality issue is recurring, systemic in nature, or impacts consumer health and safety (see Fig. 1).

FIG. 1 CAPA Process versus CAPA Subsystem

Subcomité:

D37.02

Referida por:

D8346-21A, D8222-21A, D8244-21A, D8403-21, D8244-21A, D8308-21, D8556-24, D8222-21A, D8477-22, D8308-21

Volúmen:

15.10

Número ICS:

11.120.99 (Other standards related to pharmaceutics), 65.020.20 (Plant growing)

Palabras clave:

cannabis; CAPA; correction; corrective action; investigation; hemp; preventive action; root cause;