The Annex 1 introduces new guidelines for equipment and utility systems in pharmaceutical sterile production. These guidelines focus on specific requirements, particularly those under increased regulatory scrutiny, to ensure that all Critical Control Points (CCP) and Critical Process Parameters (CPP) are fully managed and documented.
System Impact Assessment
A key aspect of the new guidelines is the need for an accurate system impact assessment, which includes:
- Accurate and live documentation: This must be updated in real-time to reflect any changes or updates in the system.
- Critical alarm assessment: Identification and rigorous testing of critical alarms are essential to prevent undesired batch progressions. The absence of critical alarms could compromise product safety.
Management of Direct and Indirect Product Contact Parts
Annex 1 provides greater clarity on the sterilization of indirect product contact parts. It is crucial to ensure that all parts indirectly in contact with the product are adequately sterilized to prevent contamination.
Monitoring and Calibration of Particle Counters
The updated ISO14644 standards require more detailed monitoring of non-viable particles. This implies that the placement and maintenance of particle counters must comply with standards to avoid unwanted contamination during the production process.
Requirements for Purified Water Systems
To ensure the quality of water used in sterile production, Annex 1 recommends:
- Continuous flow monitoring: To ensure turbulent flow, considered a CPP.
- Distillation as the preferred method: For the production of Water for Injection (WFI), although other methods may be acceptable with appropriate justification.
- Design to minimize microbial and endotoxin contamination risks: Optimizing elements such as line slopes and reducing dead legs.
Steam Quality and Heat Exchanger Testing
The standard for steam used in sterile processes requires particular attention to its physical parameters, including humidity and superheat. Heat exchangers, especially those in the cooling zone of sterilization tunnels, must be designed and monitored to prevent leaks and ensure adequate sterilization.
Conclusions
The new Annex 1 introduces detailed requirements for the management and qualification of equipment and utilities in sterile environmentsr. Compliance with these guidelines requires rigorous documentation management and continuous risk assessment.
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