Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices

Importancia y uso:

4.1 This standard provides guidance on using failure modes, effects and criticality analysis (FMECA), and hazard analysis and critical control points (HACCP) to perform the risk identification and risk analysis on cleaning procedures as required in Guide E3106. While this standard describes the use of FMEA/FMECA and HACCP/HARPC for risk analysis of cleaning processes, other risk assessment tools may be used as well (see ICH Q9 (R1) and ISO 13053).

4.1.1 The medical device industry is very broad and includes many diverse devices that have been handled differently than pharmaceuticals. Some medical devices can benefit from using an HBEL approach similar to pharmaceuticals. If an HBEL approach is used with a medical device, then this standard is applicable to performing an FMECA on their cleaning procedures. For devices where this approach is not applicable, see the ISO 10993 series of documents.

4.1.2 Microbiological concerns are also not directly addressed using the HBEL approach in this standard. However, the hazard identification, risk analysis, and HACCP steps can be applied to microbiological hazards (see also PDA Technical Report No. 54 and ISO 2200).

4.2 Application of the approach allows data-driven risk reduction/risk control for manual, semi-automated (clean-out-of-place), and automated (clean-in-place) cleaning procedures and can be adapted/amended to specific cases.

4.3 Application of the approach allows evaluation of process analytical technology (PAT) tools to assess the adequacy of cleaning procedures (Guide E2476).

4.4 Key Concepts—This guide applies the following key concepts: (1) quality risk management (QRM), (2) failure modes, effects and criticality analysis (FMECA), (3) hazard analysis and critical control points (HACCP), (4) science-based approach, and (5) risk-based approach.

Subcomité:

E55.13

Volúmen:

14.01

Palabras clave:

cleaning validation; FMEA; FMECA; HACCP; HARPC; risk-based; science-based;