All regulatory bodies expect to see environmental data reviewed as part of the batch-release procedure for sterile products. This may be confined to the data obtained from the Grades A and B aseptic areas. A summary of the data obtained during the period in which the batch was manufactured is most often included in the batch records. Alternatively, a formal statement from microbiological QA of satisfactory results may be included.
It is sensible to review environmental data in relation to batch release. However this may tend to lead to a perspective that environmental monitoring data are batch-related, rather than part of a continuous process leading to the provision of a satisfactory microbiologically controlled environment. The environmental data obtained in the periods both before and after a batch was made, may be equally as applicable as data obtained during the time the batch was manufactured. This should be appreciated in whatever mechanism is applied to a review of environmental data as part of batch release.
This review may be useful leverage to microbiological QA. Batches should not be released until environmental action limit infringement documentation has been closed out. Most batches of sterile pharmaceutical products are quarantined for seven or 14 days after manufacture, while the test for sterility is incubating. This should be sufficient time for action limit infringement reports to be released, corrective actions taken, remonitoring and the completion of documentation.
All action limit infringement reports should be sent to the batch records of the batch made at the time of the infringement and the immediately preceding and subsequent batches. Release of these batches is not permitted until the reports are formally closed out to the satisfaction of QA.
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