Pharmaceutical Validation

Pharmaceutical Validation

WHAT IS THE QUESTION ???

Hi Sir,

Could you please let me more insights about the QR2 (R2) VALIDATION OF ANALYTICAL PROCEDURES co-validation. How we will get benefit and what is the way Forword to handle this type of validation.

In which guidelines mentioned frequency of purified water heat sanitization?

There are no specific guidelines on the frequency of any type of sanitization of purified water systems (Chemical, Thermal, Steam, UV-light method).
WHO guidelines specify different methods of sanitization of the purified water system. And establishing its frequency based on microbiological trend data and validation.
This is reproduced below, (WHO- Annex 3 Good manufacturing practices: water for pharmaceutical use, TRS 1033 -2021)

  1. System sanitization and bioburden control
    8.1 Water treatment, storage, and distribution systems should be subjected to
    controls that will reduce the risk of contamination and the proliferation of
    microbiological organisms.
    8.2 Controls may include using chemical and/or thermal sanitization
    procedures as appropriate for production, storage and distribution systems.
    The procedure and conditions used (such as times and temperatures, as
    well as the frequency), should be defined and proven to be effective for
    sanitizing all relevant parts of the system. The techniques employed should
    be considered during the design stage of the system as the procedure and
    technique may impact on the components and materials of construction.

SANITIZATION:- Microbial control in water systems is achieved primarily through sanitization practices. Systems can be sanitized using either thermal or (photo-) chemical means.

Sanitization steps require validation to demonstrate the ability to reduce and hold microbial contamination at acceptable levels.
Validation of thermal methods should include a heat distribution study to demonstrate that sanitization temperatures are achieved throughout the system, including the body of use point valves; sampling ports; instrument side branches; and fittings, couplings, and adapters, relying on water convection and thermal conduction through system materials for heat transfer to wetted surfaces.
The routine frequency of sanitization should be supported by the results of system microbial monitoring (Validation of sanitization).
Conclusions derived from trend analysis of the microbiological data should be used as the alert mechanism for the need for extraordinary maintenance.
The routine frequency of sanitization should be established in such a way that the system operates in a state of microbiological control and does not regularly exceed Alert and Action Levels.

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