The policy document should be very stable. If found otherwise in practice, it merits serious review. Conversely, the site program document is intended to reflect actual practice, and may be subject to more frequent revision.
• First of all the program document should contain a floor plan of the aseptic facility with the areas within the area clearly identified by their grades.
• On this floor plan the locations for environmental monitoring should be marked. The locations should be identified versus the monitoring technique to be used at each particular location (say, T01-n for total particle counts, V01-n for active microbial air samples, etc.).
• It is then quite easy to tabulate the locations against frequency of testing (e.g., batch- or time-related), and against the alert and action limits to be applied.
• The program document should identify how media and equipment should be taken into aseptic areas, how samples should be labelled, and how they should be accounted for and reconciled for incubation, read out and review.
• The program document should ideally contain a flow diagram of responsibilities and interfaces.
• The program document should contain copies of all formal report forms.
• The program should contain directions about what to do when limits are exceeded.
• The program should state which of the microorganisms recovered in the program should be identified. The extent of identification may be quite different from one area grade to another.
The environmental monitoring program document should describe everything the personnel involved in undertaking environmental monitoring need to know. There are also important things that it should not contain, best referenced to other formal documents that can be self-contained. These other documents should, in common with the site environmental policy document, be quite stable. In "process" order these document should separately address the following "enabling" processes:
• Media preparation
• Growth support tests
• Total particle counters and how to use, maintain and calibrate them
• Microbiological sampling methods (e.g., active air sampling, swabbing, settle plates, etc.). These can be addressed in one document or split out into one document for each technique
• Identification of microorganisms
• Handling of out-of-specification and atypical results
• Conduct and reporting of trend analyses
The author favors the principle of a documentation system that allows environmental monitoring to be addressed in a practical way, with procedures compartmentalized and focused for the likely tasks done by different personnel.
Thus documents will be facilitated as training aids and as day-to-day guidance, in the ongoing quest for safe pharmaceutical manufacturing environments and patient benefit.
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