What is role of viable monitoring programme in pharmaceutical manufacturing facility?

• Environmental monitoring programme(Viable monitoring programme) to prevent product contamination before release on the market.
• In any environment where humans operators are present, microbial contamination at some level is inevitable. 
• Zero contamination at all locations during every aseptic processing operation is technically not possible and this is unrealistic.
• The complete absence of growth  on a microbial sample means only that growth was not discovered, it doesn't means that the environment is free of contamination.
• Viable monitoring programme involves  reduce the microbial contamination on pharmaceutical product. 
• If any viable monitoring excursion was observed during filling activity or any critical activity, that batch was not discarded, before release that batch proper investigation is required. 
• These excursion  are key elements of  proper investigation and identification of contamination.
• In the case of an isolated single excursion, establishing a definitive cause probably will not be possible, and only general corrective measures can be considered.
• Corrective actions may include but are not limited,

           1. Revision of the sanitization program.

           2. Selection of antimicrobial agents.

           3. Review of microbiological sampling methods and techniques

           4. Increased surveillance of personnel practices, possibly including written critiques of aseptic                methods and techniques
            5. When higher than typical recovery levels for glove and garment contamination are                             observed,additional training for gowning practices may be indicated.

           

• The viable monitoring programme ensure that an aseptic processing area maintained in an adequate level of control.
• Viable monitoring programme is a qualitative exercise and semi quantitative exercise this not given more accurate results such as aseptic processing, conclusion regarding lot acceptability should not be made on the basis of environmental sampling results alone.
• Environmental monitoring cannot prove or disprove in absolute terms the sterility of a lot of product.
• Environmental monitoring can only assure those responsible for a process that a manufacturing facility consistent, validated state of control. Care should be taken to avoid drawing inappropriate conclusions from monitoring results.
• Environmental microbial monitoring and analysis of data by qualified personnel can assist in ensuring that a suitable state of control is maintained.