With regard to industry standard batch record review times; in a
previous company, which was a solid oral dose production facility, we
were benchmarked by an external consultant for operational parameters
such as this (in 2008), and from memory, the industry standard for
review was around 10 days. With "lean" techniques it is possible to
reduce this significantly, however in practice it is rarely of
benefit to reduce batch record review times to shorter than the time
required for your longest analytical test (typically micro).
Regards
Anthony Mc Mahon
Anthony Mc Mahon
Quality and Regulatory Manager
Azur Pharma Ltd
Tel: + 353 1 634 4208
Fax: + 353 1 634 4188
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